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FDA-ICMAD Simplified Guide to Cosmetic Labeling


FDA-ICMAD SIMPLIFIED GUIDETO COSMETIC LABELING

The information contained in this guide is based upon FDA slide presentations at various cosmeticworkshops jointly sponsored by the Independent Cosmetic Manufacturers & Distributors, Inc. andthe Food and Drug Administration throughout the United States since 1983. The source of eachregulatory requirement is identified by the applicable Federal law and/or code as well as by therespective title, section and paragraph. The purpose of this simplified guide is to assist cosmeticcompanies in labeling their products in compliance with the referenced statutory and regulatoryrequirements. ICMAD disclaims any liability for the accuracy of labeling decisions based solelyupon the information contained in this guide.

Edited by: Jerome N., Michell, ICMAD Executive Director EmeritusPenni Jones, ICMAD Executive Director

Sheila Sebor, Associate Executive Director

ACKNOWLEDGMENTS

ICMAD gratefully acknowledges the assistance of:

The Office of Cosmetics and ColorsUnited States Food & Drug Administration for their invaluable cooperation and

technical expertise in arranging this guide.

ICMAD’s Technical & Regulatory Compliance Committee for its helpful comments

Copyright©1989, 1996Independent Cosmetic Manufacturers and Distributors, Inc.

No portion of the FDA-ICMAD SIMPLIFIED GUIDE TO COSMETIC LABELING may be repro-duced in whole or in part in any form or by any electronic or mechanical means, includinginformation storage and retrieval systems without written permission from the

INDEPENDENT COSMETIC MANUFACTURERS & DISTRIBUTORS, INC.1220 West Northwest Highway, Palatine, Illinois 60067-1803

Library of Congress Catalog Card No. 89-81339

PRINTED IN THE UNITED STATES OF AMERICA


TABLE OF CONTENTS

PAGE NO.Laws regulating cosmetics

Food, Drug and Cosmetic Act........................................................................ 1Fair Packaging & Labeling Act....................................................................... 2

DefinitionsMisbranding................................................................................................. 3-5Cosmetic........................................................................................................ 6Intended Use................................................................................................. 7Cosmetics which are also Drugs.................................................................. 8Consumer Commodity.................................................................................. 9Package....................................................................................................... 10Label............................................................................................................. 11Labeling........................................................................................................ 12

Principal Display Panel (PDP)Definition....................................................................................................... 13Placement and Size...................................................................................... 14Outer Container............................................................................................ 15Inner Container............................................................................................. 16

Stating Required InformationProminence and Conspicuousness.......................................................... 17,18Language..................................................................................................... 19Type Size..................................................................................................... 20Statement of Identity.................................................................................... 21Name and Place of Business...................................................................... 22Quantity of Contents.............................................................................. 23-27

Warning StatementsGeneral Requirements................................................................................. 28Unsubstantiated Safety................................................................................ 29Aerosols.................................................................................................. 30,31Feminine Deodorant Sprays........................................................................ 32Foaming Detergent Bath Products.............................................................. 33


PAGE NO.Ingredient Labeling

General Requirements................................................................................. 34Prominence.................................................................................................. 35Type Size..................................................................................................... 35Identification of Ingredients.......................................................................... 36

Order of Declaration............................................................................. 37,38Color Additives............................................................................................. 39Fragrances................................................................................................... 40Flavors......................................................................................................... 40

Trade Secret IngredientsGeneral Information..................................................................................... 41Definition...................................................................................................... 42Requesting Trade Secrecy........................................................................... 43Exemption from Label Declaration........................................................... 44,45Determining Trade Secret Status............................................................. 46-48Requesting Exemptions........................................................................... 49,50

Cosmetics Which are Also Drugs............................................................... 51,52Color Additives for Matching...................................................................... 53,54Incidental Ingredients...................................................................................... 55

Multiunit/Multicomponent PackagesDefinitions................................................................................................... 56Dissimilar Products...................................................................................57-59Similar Products...................................................................................... 60-62Branded Shade Lines.............................................................................. 62-65

Direct Mail CosmeticsDefinition..................................................................................................... 66Declaration of Ingredient.............................................................................. 67Off-Package Labeling.............................................................................. 68-74

SUNSCREEN PRODUCTS SUPPLEMENT.................................................. 75-87INDEX............................................................................................................. 88,89FDA OFFICES................................................................................................ 90,91ICMAD OFFICE....................................................................................Back Cover


HOW TO USE THIS LABELING GUIDE

To obtain a general understanding of cosmetic labeling requirements and theirunderlying laws and regulations, it is suggested that the guide first be read inits entirety.

The guide introduces the reader to the laws and statutory provisions appli-cable to cosmetic labeling, describes pertinent legal definitions and discussesin some detail individual requirements related to stating the required labelinformation such as how and where on the label to state the name andaddress of the manufacturer or distributor, the net quantity of contents, therequired warnings or cautions and the declaration of ingredients.

While the guide attempts to address all commonly occurring cosmetic labelingissues, certain specific and less frequently encountered questions mayrequire further study and clarification.

To obtain additional information, contact your particular FDA district office,FDA headquarters staff, ICMAD (phone and fax numbers and email addressare listed in the back of this guide) or a knowledgeable attorney.


1

The cosmetics marketed in the United States,whether they are manufactured here or areimported from abroad, must comply with thelabeling requirements of the Federal Food, Drug,and Cosmetic (FD&C) Act, the Fair Packagingand Labeling (FP&L) Act, and the regulationspublished by the Food and Drug Administrationunder the authority of these two laws.

The FD&C Act was enacted by Congress toprotect consumers from unsafe or deceptivelylabeled or packaged products by prohibiting themovement in interstate commerce of adulteratedor misbranded food, drugs, devices and cos-metics.


2

The FP&L Act was passed by Congress toensure that packages and their labels provideconsumers with accurate information about thequantity of contents and facilitate value compari-sons.


3

The FD&C Act prohibits the marketing of cos-metics that are adulterated or misbranded aswell as their adulteration or misbranding while ininterstate commerce.


4

Sec. 602 of the FD&C Act defines the conditionswhich cause a cosmetic to be deemedmisbranded.


5

Labeling may be considered misleading not onlybecause a label statement is deceptive but alsobecause a material fact is not revealed on alabel.

A fact may be material in light of a statementmade on a label or because certain conse-quences may result from the recommended useof a product.


6

As defined in section 201(i) of the FD&C Act, acosmetic is a product, except soap, intended tobe applied to the human body for cleansing,beautifying, promoting attractiveness or alteringthe appearance.

In short, one may say that a cosmetic is aproduct intended to exert a physical, and not aphysiological, effect on the human body.

The raw materials used as ingredients of cos-metic products are by law also cosmetics. Insection 701.20 of Title 21 of the Code of FederalRegulations [21 CFR 701.20], the Food and DrugAdministration (FDA) defines the term “soap” asa product in which the non-volatile portionconsists principally of an alkali salt of fatty acids,i.e., the traditional composition of soap; theproduct is labeled as soap; and the label state-ments refer only to cleansing. If cosmeticsclaims, e.g., moisturizing, deodorizing, skinsoftening etc., are made on a label, the productis a cosmetic. Synthetic detergent bars are alsoconsidered cosmetics, although they may belabeled as “soap”.


7

According to Senate Report No. 493 and courtdecisions, the term “intended” in the legaldefinition of the term “cosmetic” or in otherdefinitions means, with respect to the use of aproduct, its directed or prescribed use as deter-mined from the statements made on a product’slabel or labeling.

The courts, in deciding whether a product is a“cosmetic”, a “drug”, or both a “drug” and a“cosmetic”, have relied principally on theconsumer’s perception of the meaning of a labelstatement and less so on the interpretation of themeaning of a label statement by the labeler or aregulatory agency.


8

A cosmetic is legally also a drug if it is intendedto exert a physical as well as a physiologicaleffect because the FD&C Act defines in section201(g) the term “drug” to mean, among otherthings, “articles intended for use in the...cure,mitigation, treatment, or prevention ofdisease...and...articles ...intended to affect thestructure or any function of the body...”

Section 509 of the FD&C Act provides that thecategories of “drug” and “cosmetic” are notmutually exclusive.


9

The term “consumer commodity” is defined insection 10(a) of the Fair Packaging and LabelingAct.

Not all cosmetics are considered consumercommodities. Professional products, e.g.,products used exclusively by beauticians orcosmeticians in beauty salons or cosmeticstudios, and cosmetics distributed free at hotels,for example, are not legally considered to beconsumer commodities. However, so-called “giftwith purchase” products are consumer com-modities because the “gift” is available only inconjunction with a retail sale activity.


10

The term package is defined in the Fair Packag-ing and Labeling Act [sec. 10(b)] and the Code ofFederal Regulations - [21 CFR 1.20].

Essentially, the “package” is the outer containerof a product as, for example, a box or foldingcarton. However, the “package” can also be theimmediate container, e.g., bottle, jar or aerosolcan that holds the product if the immediatecontainer is not displayed in a box or foldingcarton.


11

The term “label” is defined in the FD&C Act andthe FP&L Act. The definitions differ in that underthe FD&C Act definition a label is “a display ofwritten, printed or graphic matter upon theimmediate container”, and under the FP&L Actdefinition “written, printed or graphic matteraffixed to any consumer commodity or affixed toor appearing upon a package containing anyconsumer commodity.”

One may say that the term “label” applies in thefirst instance to the information appearingdirectly on the immediate container and in thesecond instance to information attached to theimmediate container and directly on or attachedto the outer container if so packaged.

The FD&C Act, however, requires in sec 201(k)that any information required to appear on thelabel of the immediate container shall alsoappear on the outside container of the retailpackage or is legible through the outside con-tainer.


12

The FD&C Act defines in sec. 20(m) “labeling” tomean “all labels and other written, printed orgraphic matter on or accompanying such article.”

This includes labels, inserts, risers, displaypacks, leaflets, promotional literature or anyother written or printed information distributedwith a product.


13

A label may consist of more than one panel. Itmay consist of a front panel, side panels and aback panel. Back and side panels are generallycalled information panels.

The FP&L Act also defines for consumer com-modities, packages containing a consumercommodity, the term “principal display panel,”otherwise known for short as PDP.

The “principal display panel” is that part of apanel that is most likely to be shown or exam-ined under customary conditions of display forretail sale. Usually, it is the front panel of thelabel of the outer package.


14

As mentioned before, the PDP is that part of thelabel that is most likely to be shown or examinedunder customary conditions for retail sale.

Regulations [21 CFR 701.10] published by theFDA require that the PDP be large enough toaccomodate all required label information withclarity and conspicuousness.

If a package bears more that one PDP, theinformation required to be placed on the PDPmust be duplicated on all PDPs.

For the purpose of assuming uniform type sizefor declaring a product’s net quantity of contents,the size of the surface area bearing the PDP, andnot the size of the PDP itself, is the determiningfactor. The area of the PDP is for a:

Rectangular package: One entire side.

Cylindrical package: 40% of height x circumfer-ence.

Any other shape of container: 40% of totalcontainer surface, excluding top, bottom, neck,shoulder, flanges.

The PDP of a “boudoir-type” or decorativecosmetic container, e.g., cartridge, pill box,compact or pencil variety, and those containing1/4 card to which the immediate container isaffixed [21 CFR 701.13(e)(2)].


15

The following information must appear on thelabel of the outer container which usually is abox, folding carton, wrapper, etc. holding theinner (immediate) container. The immediatecontainer holding the cosmetic product also isthe outer container if it is not displayed in a box,folding carton, etc.

Please note that only the label of an outercontainer has a PDP.

Statement of the brand name of the product isnot a regulatory requirement under the FD&C orFP&L Act.

*NOTE: Directions for safe use are notrequired but may be appropriate for yourparticular product.


16

The following information must appear on thelabel of the inner (immediate) container holdingthe cosmetic product. The inner container ispackaged and displayed in a non-transparentbox, folding carton, etc. If the outer container isremoved, and the product displayed for salewithout it, the label of the immediate containerbecomes a label of an outer container.

*NOTE: Directions for safe use are notrequired but may be appropriate for yourparticular product.


17

Section 602(c) of the FD&C Act deems acosmetic misbranded if any word, statement, orother label or labeling information required bylaw or regulation is not placed on the label orlabeling with such prominence and conspicuous-ness that is likely to be read, or if it is not statedin such terms that it is likely to be understood byordinary individuals.


18

Regulations [21 CFR 701.2] published by theFDA offer detailed information on how to complywith the requirement for prominent and conspicu-ous placement of information on cosmetic labelsor labeling.

Panel Display: The required information mustbe on a panel which is presented or displayedunder customary conditions of purchase. Thiseliminates placement of required information ona bottom panel of a cosmetic unless it is verysmall and customarily picked up by hand wheninspected for possible purchase.

Panel Size: The label must be large enough toprovide sufficient space for prominent display ofthe required information.

Style and Size of Letters: The type must be ofsuch size, and at least of the required minimumsize, and of such style that the required labelstatements are easily readable.

Background Contrast: The contrast must besufficient to make the required label statementsconspicuous and easily readable.

Obscuring Designs, Vignettes: The requiredstatements must not be obscured by vignettes orother designs or by crowding with other printedor graphic matter.


19

English Language Statements: All label orlabeling statements required by law or regulationmust be in the English language. Productsdistributed solely in Puerto Rico or a Territorywhere the predominant language is one otherthan English, may state the required labelinformation in the predominant language in placeof English.

Foreign Language Statements: If the labelcontains any foreign language representation, allstatements required by regulation must alsoappear on the label in the foreign language. Iflabeling bears foreign language representations,the required statements must appear on thelabel or other labeling as required in English.


20

Ingredient Declaration: Generally, in letters notless than 1/16” in height [21 CFR 701.3(b)]. Ifsurface area available to bear label (excludessurfaces with decorative relief, sculpturedsurfaces) is less than 12 square inches, letterheight may be not less than 1/32” [21 CFR701.3(p)].

Net Contents Declaration on PDP: Minimumletter height determined by the area of the PDP.In the case of “boudoir-type” containers, includ-ing decorative cosmetic containers of thecartridge, pill box, compact or pencil type, andcosmetics of 1/4oz. or less capacity, the typesize is determined by the toal dimensions of thecontainer. If the container is mounted on adisplay card, the display panel determines theletter height [21 CFR 701.13(e) and (i)].

Warning Statements: Type size is no less than1/16” unless smaller size established by regula-tion [21 CFR 740.2].

Identity Statement and Others: Type sizemust be reasonably related to the most promi-nent printed matter on a panel [21 CFR 701.11].

Letter Height: The lower case letter “o” orequivalent when upper and lower case letters areused [21 CFR 701.13(h)].


21

Sec. 4 of the FP&L Act [21 U.S.C 14554] re-quires that a consumer commodity bear astatement of identity. Regulations [21 CFR701.11] published by the FDA require that theidentity statement appear on the PDP.

The identity of the commodity may be expressedin terms of the common or usual name of thecosmetic, a descriptive name, or when thenature of the cosmetic is obvious, a fancifulname. It may also be expressed in form of anillustration.

The identity statement must be in bold type andin a size reasonably related to the most promi-nent printed matter which is usually the name ofthe cosmetic. It must be in lines generallyparallel to the base on which the product restswhen displayed at retail.


NAME AND PLACE OF BUSINESSCORPORATE NAME

MANUFACTURED FOR . . .

DISTRIBUTED BY . . .

ADDRESS

PRINCIPAL PLACE OF BUSINESS

21 CFR 701.12

22

The name and business address appearing onthe label may be those of the manufacturer,packer or distributor.

If the name and address is not that of themanufacturer, the name must be preceded byphrases such as “Manufactured for...”, “Distrib-uted by...”, or other appropriate wording.

The name of the firm must be the corporatename, and the address may be that of theprincipal place of business. Stating also thename of a corporation’s particular division isoptional.

The business address must include the streetaddress, name of the city and state, and ZIPcode. The street address may be omitted if thefirm is listed in a current city or telephonedirectory.

The Tariff Act of 1930 requires that importedproducts state on the label the English name ofthe country of origin.


23

Location: If the cosmetic is sold at retail in anouter container, the net contents statement mustappear (1) within the bottom 30% of the PDP ofthe outer container, generally parallel in line tothe base on which the package rests, and (2) onan information panel of the inner container. Thebottom location requirement is waived for PDPsof 5 square inches or less.

The PDP may be a tear-away tag or tape affixedto a decorative container or to a container of lessthan 1/4 oz., or it may be the panel of a displaycard to which the container is affixed.

Prominence: The declaration must be a distinctitem, separated from other printed matter by aspace equal to at least the height of the letteringused in the declaration and twice the width of theletter “N”.

Conspicuousness: The print must be easilylegible bold face type in distinct contrast tobackground and other matter on the package.The letter height must be at least that of thelower case letter “o” and the aspect ratio ofheight to width must not exceed 3:1.

The type size, as determined by the area of thePDP must be at least 1/16 in. if PDP area < 5sq. in., 1/8 in. if PDP area > 5 to < 25 sq. in.,3/16 in. if PDP area > 25 to < 100 sq. in., and 1/4in. if PDP area > 100 sq. in.


24

Cosmetics in packages containing less than 1/4av. oz. or 1/8 fl. oz. are exempt from the netquantity of contents declaration if affixed to aproperly labeled display card or sold at retail in aproperly labeled outer container [21 CFR 1.24].

When a cosmetic is required to bear net quantityof contents declarations on the inner and outercontainer, the declaration on the outer containermust appear on the PDP; on the inner container,it may appear on an information panel other thanthe panel bearing the name of the product, i.e.,the front panel.


25

Accuracy: The net quantity of contents (netcontents) declaration must accurately reveal thequantity of cosmetic in the container in terms ofweight, volume, measure, numerical count, orcombinations of count and weight, volume ormeasure. Reasonable variations due to loss orgain of moisture, or deviations in good manufac-turing practice, are acceptable. In case of anaerosol product, the net contents statement mustexpress the net quantity of contents expelled.

Product Consistency: Unless there is a firmlyestablished, general consumer usage or tradecustom to the contrary, the statement must be interms of fluid measure if the cosmetic is liquidand in terms of weight if the cosmetic is solid,semi-solid, viscous, or a mixture of solid andliquid. Fluid measures must express the volumeat 68o F (20o C).

The customary net contents declaration foraerosol products is in terms of weight.

Systems: Weight is expressed in terms ofavoirdupois pound and ounce. Fluid measuresare expressed in terms of the U.S. gallon, quart,pint and fluid ounce. Net contents may addition-ally be stated also in the metric system.

Unit Terms: The term “net weight” or “net wt.”must be used in conjunction with a weightstatement, and the term “net contents”, “net” ornothing must be used in connection with a liquidstatement.

Additional abbreviations are for: weight - wt.,fluid - fl., gallon - gal., quart - qt., pint - pt.,ounce - oz., pound - lb.

(continued next page)


26

(continued from previous page)

In case of a weight ounce statement, the term “oz.”is sufficient. A fluid ounce is expressed as “fl. oz.”

Examples: Net wt. 4 av. oz. Net contents 4 fl. oz.4 av. oz. net wt. Net 4 fl. oz.4 oz. net wt. 4 fl. oz.

Dual Declaration: If the net weight exceeds onepound but is less than 4 pounds, the net contentsstatement must reveal the total number of ouncesfollowed, in parentheses, by the number of poundsand fraction thereof. Fluid measures exceedingone pint, but being less than one gallon, must beexpressed in terms of the total number of fluidounces followed, in parentheses, by the number ofquarts, pints and ounces or by the fractions of thequart or pint.

Examples:Net Wt. 24 oz. (1 lb. 8 oz.) 56 fl. oz. (1 qt. 1 pt.

8 fl. oz.)Net Wt. 24 oz. (1-1/2 lb.) 56 fl. oz. (1 qt. 1-1/2

pt.)Net Wt. 24 oz. (1.5 lb.) 56 fl. oz. (1 qt. 1.5 pt.)

56 fl. oz. (1-3/4 qt.)

Declarations of Fractions: Fractions may beexpressed in terms of common fractions rangingfrom 1/2 to 1/32 or as decimal fractions of nomore than three significant numbers.

Metric Units: The law requires that the netcontents be declared in metric units as well asinch-pound units. However, FDA has not pub-lished final regulations on how the declaration isto be made. The Agency recommends that if youwish to avoid having to change labels againwhen the regulations on the metric declarationbecome effective, you should add the metriccontents statements now, using the guidanceprovided in the proposed regulations published inthe Federal Register on December 21, 1993.FDA expects that any differences between theproposal and the final regulations will be minorand will not by themselves require a labelchange.


27

Economy Size: Representations of this typeare permitted if the firm offers at least one otherpackaged size of the same brand, only one islabeled “ecomomy size,” and the unit price of thepackage so labeled is substantially (at least 5%)reduced compared to that of the other package.

Giant Pint, Full Quart: Supplemental state-ments describing the net quantity of contents arepermitted on panels other than the PDP. How-ever, these statements must not be deceptive orexaggerate the amount present in the package.

Six Applications: Declarations by numericalcount or linear or area measure may be aug-mented by statements of weight or size ofindividual units or total weight or measure to giveaccurate information. These are not regarded asseparate statements and must appear on thePDP.

Cosmetic Kit: If a package contains the integralcomponents making up a kit and delivers thecomponents in the manner of an application as,for example, a home permanent wave kit, the netcontents declaration may be stated in terms ofthe number of applications as per given instruc-tions [21 CFR 701.13(g) (2)].


28

Regulations require that “[t]he label of a cosmeticproduct shall bear a warning statement when-ever necessary or appropriate to prevent ahealth hazard that may be associated with theproduct” [21 CFR 740(1)]. A cosmetic notbearing a necessary warning statement may beconsidered misbranded under sec. 602(a) of theFD&C Act because it fails to reveal a fact“material...with respect to consequences whichmay result from the use of the article” [sec.201(n), FD&C Act.]

Prominence: A warning statement must appearon the label prominently and conspicuously ascompared to other words, statements or designsso that it is likely to be read by ordinary consum-ers at the time of purchase and use.

Conspicuousness: The lettering must be inbold type on contrasting background and may inno case be less than 1/16 inch in height.


29

A cosmetic is considered misbranded if its safetyhas not adequately been substantiated, and itdoes not bear the following conspicuous state-ment on the PDP:

Warning-The safety of this product has notbeen determined.

The safety of a cosmetic may be consideredadequately substantiated if experts qualified byscientific training and experience can reasonablyconclude from the available toxicological andother test data, chemical composition, and otherpertinent information that the product is notinjurious to consumers under conditions ofcustomary use and reasonably foreseeableconditions of misuse.

The safety of a cosmetic can adequately besubstantiated by:

a. Reliance on available toxicological test dataon its ingredients and on similar products,and

b. Performance of additional toxicological andother testing appropriate in the light of theexisting data.

Even if the safety of each ingredient has beensubstantiated, there usually still is at least sometoxicological testing needed with the formulatedproduct to assure adequate safety substantiation.


30

The label of a cosmetic packaged in a self-pressurized container and intended to be ex-pelled from the package under pressure mustbear the warning stated above.

The words “Avoid spraying in eyes” may beomitted if the product is not expelled as a spray.Example: Aerosol shave cream.

The word “puncture” may be replaced by theword “break” if the product is packaged in aglass container.

If the product is intended for use by children, thephrase “except under adult supervision” may beadded at the end of the last sentence of thewarning.


31

If the propellant of a cosmetic packaged in aself-pressurized container consists in whole or inpart of a halocarbon or hydrocarbon, the labelmust bear a second warning as stated above.

This second warning is not required for thefollowing products:

1. Aerosol foam or cream products containingless than 10% propellant.

2. Products which do not expel the product atthe time of use. Example: products withbuilt-in piston barrier or propellant bag.

3. Metered spray products of less than 2 oz.net contents.

4. Aerosol products of less than 1/2 oz. netcontents.


32

A feminine deodorant spray which, for thepurpose of this regulation, is defined as “anyspray deodorant product whose labeling repre-sents or suggests that the product is for the usein the female genital area or for use all over thebody” must bear the caution stated above.

If the expelled product does not contain aliquified halocarbon or hydrocarbon propellant,the sentence “Spray at least 8 inches from skin”may be omitted.

The regulation further states that the use of theword “hygiene” or “hygienic” or similar wordsrenders any such product misbranded.


33

A foaming detergent bath product - also knownas bubble bath product - is, for the purpose ofthis regulation, defined as “any product intendedto be added to a bath for the purpose of produc-ing foam that contains a surface-active agentserving as a detergent or foaming ingredient.”

The caution stated below is required on the labelof any foaming detergent bath product which isnot clearly labeled as intended for use exclu-sively by adults. The following are two examplesof label statements identifying a product asintended for use exclusively by adults. “Keep outof reach of children” and “For adult use only.”

If the bubble bath product is intended for use bychildren, the phrase “Keep out of reach ofchildren” may be expanded to further read“except under adult supervision.”

The regulation further requires that the label“shall bear adequate directions for safe use” ofthe product.


34

Cosmetic ingredient labeling became an issue inthe early 1970s. Guidelines for ingredientlabeling were published in mid-1972. Regulationswere proposed in early 1973. After publication oftwo final regulations, stays of final regulations,terminations of stays, and lengthy court proceed-ings challenging the legality of the publishedregulations, the requirement for cosmeticingredient labeling became fully effective inearly 1977.

The regulations requiring the declaration ofcosmetic ingredients were published under theauthority of the FP&L Act [secs. 5(c) and 6(a); 15U.S.C. 1454 and 1455] and the FD&C Act [sec.701(e); 21 U.S.C. 371(e)].

Since the final FP&L Act applies only to con-sumer commodities and their packages asdefined in the Act, cosmetic ingredient declara-tions are required only on the label of the outercontainer of cosmetics customarily sold at retailor used in the performance of services

conducted within the households. It does notapply, for example, to products used at profes-sional establishments or samples distributed freeof charge unless such products are customarilyalso sold at retail, even if they were labeled “Forprofessional use only.”

The ingredients must be declared in descendingorder of predominance. Exceptions to thisrequirement are discussed later.


35

The ingredient declaration may appear on anyinformation panel of the package which is theouter container in form of a folding carton, box,wrapper, etc. if the immediate container is sopackaged, or which is the jar, bottle, box, etc. ifthe immediate container is not packaged in anouter container. It may also appear on a tag, tapeor card firmly affixed to a decorative or small sizecontainer.

Prominence: The declaration must appear withprominence and conspicuousness so that it islikely to be read and understood (read with ease)by ordinary individuals under normal conditionsof purchase. The letters must not be obscuredby design, vignettes, background or crowding.

Type Size: Not less than 1/16 inch in height. Itmay be not less than 1/32 inch in height if thetotal surface area available to bear labeling(which excludes bottom, shoulder, neck, flange,decorative or sculptured surfaces) is less than12 square inches.

The type size consisting of upper and lower caseletters is determined by the height of the lowercase “o”.


36

Section 701.3 (c) requires that an ingredient beidentified by the name established by the Com-missioner for the purpose of cosmetic ingredientlabeling or, in the absence of a name establishedby the Commissioner, the name adopted for thatingredient in the editions and supplement of thecompendia listed above.

The Commissioner may establish a name aspetitioned or propose such a name on his owninitiative. See section 701.3 (e). The namesspecified by the Commissioner are listed insection 701.30.

The currently recognized edition of the CTFA(Cosmetic, Toiletry and Fragrance Association,Inc.) Cosmetic Ingredient Dictionary is thesecond edition published in 1977. This edition isrecognized only in part, i.e., not all names listedin the second edition have been adopted.

The third edition of the CTFA Cosmetic Ingredi-ent Dictionary published in 1982 and the Supple-ment published in 1985 have not yet beenrecognized. However, FDA has informed theCTFA that the agency will not take regulatoryaction against products labeled in accordancewith these editions while their review is inprogress. A petition to recognize the fourthedition of the CTFA Cosmetic Ingredient Dictio-nary was submitted to FDA in late 1991 and iscurrently being reviewed.

The compendia are listed in the descendingorder by which they must be utilized for identifi-cation of an ingredient name. If none lists aname for an ingredient, the name generallyrecognized by consumers, or the chemical ortechnical name or description, must be used.


37

The ingredients must be listed in descendingorder of predominance. However, there are a fewexceptions to this requirement.

1. If the cosmetic is also a drug, section502(c) of the FD&C Act requires that theactive drug ingredient(s) be declared beforedeclaration of the cosmetic ingredients. Adeclaration, thus, would read as follows:“Active Ingredient: ,,,(Name of drug ingredi-ent). Other (or Cosmetic) Ingredients...(Names of cosmetic ingredients in descend-ing order).” [§701.3(d)].

2. Ingredients present at a concentration notexceeding 1% may be listed in any orderafter the listing of the ingredients present atmore than 1% in descending order ofpredominence.[§701.3(f)(2)].

3. Color additives of any concentration may belisted in any order after the listing of theingredients which are not color additives[§701.3(f)(3)].

4. The name of an ingredient accepted by FDAin accordance with the procedure estab-lished in §720.8 as a trade secret need notbe disclosed on the label. In lieu of declaringthe name of that ingredient, the phrase “andother ingredients” may be used at the end ofthe ingredient declaration [701.3(a)].


38

In this example, the correct ingredient declara-tion lists castor oil (58), lanolin (8), candelilla wax(6.5), carnauba wax (3), and ozokerite (2) indescending order of predominance. The con-centrations (which need not be declared byregulation) are provided in parentheses.

The compounds of the proprietary antioxidantmixture dissolved in propylene glycol must beintegrated into the product formulation anddeclared individually in order of decreasingpredominance without the term “(and).”

The color additives titanium dioxide (2) etc.may be declared in any order after the otheringredients.


39

The hypothetical pressed powder formulationportrayed in this example illustrates the twooptions for the listing of ingredients.

On the left side, the ingredients are listed indescending order of predominance according to§701.3(a).

On the right side, the ingredients are listedaccording to §701.3(f), (2) and (3), i.e., ingredi-ents other than colors present at a concentrationexceeding 1% in descending order of predomi-nance followed by ingredients other than colorspresent at 1% or less in any order, followed bycolors present at any concentration listed in anyorder.


40

Fragance and flavor compounds may bedeclared in descending order of predominenceas “fragrance” and “flavor.” If a fragrancecompound also serves as a flavor, it must bedeclared as “flavor and fragrance.”

The components (ingredients) of a fragrance orflavor may also be declared individually by theirappropriate label names.

The ingredient or mixture of ingredients acting asa masking agent, i.e., covering the undesirableoff-odor of a product without adding adiscernable odor to it, may be declared by theirindividual name(s) or as “fragrance” (in lieu of abetter designation). A masking agent present ina product at an insignificant level may beconsidered an incidental ingredient under701.3(1)(2)(iii) in which case it need not bedeclared on the label.


41

The FP&L Act states in section 5(c) (3) (B) [15U.S.C. 1454 (c)(3)(B) that “nothing...shall bedeemed to require that any trade secret bedivulged.” Accordingly, the cosmetic ingredientlabeling regulation does not require the declara-tion of the identity of an ingredient FDA hasaccepted as exempt from public disclosure. Inlieu of the declaration of the name of a confiden-tial ingredient, the phrase “and other ingredients”may be used at the end of the ingredientdeclaration.

The policy the agency is following for processingrequests for confidentially of cosmetic ingredientidentities has been codified under §720.8.


42

The question “what is a trade secret” may beanswered by restating the definition of the term“trade secret” as provided in §20.61 (a) ofregulations published in 1974 for enforcement ofthe law commonly known as the “Freedom ofInformation Act” (the public information sectionof the Administrative Procedures Act; 5 U.S.C.552).


43

The first step in processing a request for tradesecrecy, i.e., a request for exemption from labeldeclaration, of the identity of a cosmeticingredient is the submission to FDA of thefollowing information:

a. A semi-quantitative cosmetic formulationstatement of the product in question onForm FDA 2512.

b. A full statement of the factual and legalgrounds for the request, including all dataand other information on which the petitionerrelies (as well as any information known tothe petitioner that is unfavorable to thepetitioner’s position).

The statement of factual grounds shouldinclude scientific or technical data, reports,tests, and other relevant information thataddress the factors FDA considers indetermining whether the identity of aningredient qualifies as a trade secret. (Thefactors FDA considers are stated else-where).

c. A statement that the identity of the ingredientin question has not previously been dis-closed to anyone without appropriate safe-guards for secrecy as further explained in§20.81.


44

FDA reviews the submitted information todetermine whether the data are sufficient topermit a review of the merits of the request.

A request that contains insufficient data toconduct a confidentiality review on the merits isreturned and petitioner is advised about theadditional information that is necessary to enablethe agency to proceed with the review of therequest.


45

When the submitted information is sufficient topermit a review of the merits of a request, FDAproceeds with the review.

When the agency concurs with petitioner anddecides that the ingredient identity is a tradesecret, the request for exemption from labeldisclosure is granted. If FDA does not concurwith petitioner, the agency tentatively denies therequest. The person requesting trade secrecy isinformed in writing of the agency’s determination.In case of a tentative denial, FDA informspetitioner of the grounds on which it relied inmaking this tentative determination.


46

When FDA reviews the merits of a confidentialityrequest and determines whether the identity ofan ingredient qualifies as a trade secret, itconsiders the following three principal factors byseeking answers to the following threequestions:

1. Is the ingredient’s identity and intended usepublicly known?

2. Does the intended use of the respectiveingredient have value?

3. Can the identity of the ingredient readily beacquired by legal means and its intendeduse duplicated?

These questions are based on the factorsconsidered in Comment B to section 757 of theRestatement of Torts in determining whethergiven information is a trade secret.

Since the same factors are also being consid-ered by FDA in determining whether the identityof an ingredient qualifies as a trade secret, aperson requesting trade secrecy must addressthem factually and convincingly in the statementof grounds.

Absence of public knowledge of an ingredient’sidentity under conditions of intended use may bedemonstrated by documenting the extent towhich the information is known by employees orothers in petitioner’s business, the extent theinformation is publicly disclosed in pertinentliterature, and the extent of measures taken bypetitioner to guard the secrecy of the information.


47

The value of knowing the identity and intendeduse of the ingredient in question may be deter-mined in terms of the importance of the ingredi-ent to the product information. It must beassumed that, to be of value, the ingredientsignificantly contributes to the claimed perfor-mance or other pertinent characteristics of thecosmetic and that a cosmetic not containing theclaimed trade secret ingredient, or containingconventional substitutes in place of the respec-tive ingredient, could not be expected to performequally well or otherwise meet certain require-ments. Appropriate comparative testing of acosmetic containing the trade secret ingredient,or one containing conventional substitutes, aswell as testing of petitioner’s cosmetic againstcompetitor’s cosmetic of the same use category,may provide factual documentation to this effectand thus demonstrate the value of the informa-tion to petitioner. The value of the ingredientinformation may also be determined in terms offuture market performance of a cosmetic or itsprofitability. However, this kind of value assess-ment is usually a difficult and inexact task andoften provides little factual data to support avalue assessment.

Documentation of the effort expended andfinancial resources invested in the developmentof the product formulation containing the ingredi-ent in question and providing the claimedcharacteristics may further support a request fortrade secrecy.


48

The factor concerning the ease or difficulty withwhich the identity of the ingredient in questioncould properly be acquired or duplicated byothers may be addressed by documenting aningredient’s rare or unexpected use for theintended purpose in cosmetics of a particularproduct category or by demonstrating thecomplexity of the analytical methodology neces-sary to identify it.


49

When FDA tentatively decides to deny a request,the petitioner may withdraw the records for whichFDA has tentatively denied a request for confi-dentiality. Petitioner may also submit, within 60days from the date of receipt of the written noticeof the tentative denial, additional relevant infor-mation and arguments and request that theagency reconsider its decision in light of both theadditional material and the originally submittedinformation.

If the petitioner submits new data, the agencyconsiders that material together with the initiallysubmitted information and makes its finaldetermination. This constitutes final agencyaction. The petitioner is informed of the agency’sfinal determination in writing.


50

The agency’s final decision may be challenged inthe courts under 5 U.S.C., Chapter 7. If suit isbrought within 30 days after such determination,FDA will not disclose the records involved untilthe matter is finally determined in the courts. Ifsuit is not brought within 30 days and the peti-tioner does not withdraw the records for which arequest for confidentiality has been denied, therecords involved will be made part of FDA’s filesand will then be available to the public uponrequest.

It should be noted that until the agency hascompleted its determination that the identity of acosmetic ingedient is a trade secret, the cos-metic product in question may not bear the labelstatement “and other ingredients” in lieu of adeclaration of the identity of the ingredient forwhich confidentiality has been requested. Thephrase “and other ingredients” may be used onthe label only after an ingredient is accepted byFDA as exempt from public disclosure or, whenconfidentiality has been denied, if suit is broughtwithin 30 days after a final dermination that theingredient in question is not a trade secret.


51

A product intended to be applied to the humanbody for cleansing, beautifying, promotingattractiveness, or altering the appearance is acosmetic. If this product claims to accomplishthese deeds through physiological activity or bychanging the structure of the skin, it is also adrug. The product categories “drug” and “cos-metic” are not mutually exclusive. This isrecognized in sec. 509 of the FD&C Act.

If a cosmetic is also a drug, the label must listfirst the established name of the drugingredient(s) and the quantity, kind and propor-tion of any alcohol, in compliance with sec.502(e) of the FD&C Act, as “Active Ingredients”and then the remaining ingredients, incompliance with §701.3(a) or (f), as “CosmeticIngredients.”


52

This hypothetical aerosol antiperspirant forformulation illustrates on the right side thecorrect label declaration of the ingredients of acosmetic which is also a drug.

The active drug ingredient aluminumchlorohydrate is identified as “Active Ingredient”in accordance with sec. 502(e) of the FD&C Act.The remaining ingredients may be identified as“Cosmetic Ingredients” as shown or as “OtherIngredients.”


53

A color additive(s) that is added to a cosmeticduring manufacture for the purpose of colormatching may be declared on the label of eachbatch or lot even if not present in each.

The color additive sometimes added for colormatching is listed after the declaration of othercolor additives, or at the end of the declaration,and after the phrase “May Contain.”


54

This hypothetical toilet water formulation in whichD&C Yellow No. 10 is added to some batches forthe purpose of color adjustment shows on theright side the correct label declaration of thecolor additive D&C Yellow No. 10.


55

Incidental ingredients need not be declared on thelabel.

An incidental ingredient is defined in §701.3(1) as:

1. A substance added during manufacture andremoved from the cosmetic in accordancewith good manufacturing practices before thecosmetic is packaged in finished form.Example: Filter aid.

2. A substance that is added during manufac-ture of a cosmetic, is converted to an ingredi-ent declared on the label, and does notsignificantly increase the concentration of thedeclared ingredient. Example: Sodiumhydroxide added to a sodium stearate andstearic-acid containing cosmetic.

3. A substance added to a cosmetic duringmanufacture for its technical effect in pro-cessing but present in the finished cosmeticat an insignificant level and not having anytechnical or functional effect in that cosmetic.Example: Defoaming agent.

4. A substance added to a cosmetic as acomponent of a cosmetic ingredient andhaving no technical or functional effect inthe finished cosmetic. Example: Preservativeof a raw material added to a cosmetic as aningredient at a concentration which reducesthe preservative to a level at which it is nolonger effective.


56

The ingredients of the units of cosmetics mar-keted as multiunit or multicomponent packagesmust be declared on the label of the outsidecontainer. They must also be declared on thelabels of the inside containers of the units if theinside containers are customarily separated fromthe outer container for individual retail sales.

A MULTIUNIT package is a package whichcontains an assortment of similar or dissimilarproducts. Examples: A shade assortment of eyeshadows in an eye make-up kit or a gift setconsisting of a lotion, powder and toilet water ina gift box.

A MULTICOMPONENT package is “a packagewhich contains the integral components makingup a complete kit, and which is designed todeliver the components in the manner of anapplication.” See 21 CFR 701.13(g)(2). Ex-amples: A hair coloring kit consisting of dyesolution and hydrogen peroxide or a permanentwave set consisting of thioglycolate solution andsodium bromate solution.


57

For the purpose of cosmetic ingredient labelingand to take advantage of provisions for consoli-dated ingredient listing in place of sometimesrepetitive listing of ingredients unit by unit, adistinction must be made between packagescontaining:

1. Dissimilar products. Example: Gift setcontaining a shave cream and an aftershave lotion.

2. Products of similar composition and intendedfor the same use in a package with a totalsurface area available for labeling of 12square inches or more. Example: Twotoilet waters of different fragrance or colorin gift set.

3. Products of similar composition and intendedfor the same use in a package with a totalsurface area available for labeling of lessthan 12 square inches. Example: Eyeshadows of different colors in a compactcase.

4. Products that are single units or assortmentsof a branded shade line. A branded shadeline is a series of products of similar compo-sition, intended for the same use, andsharing a common label with the same brandname. Example: A shade line of lipsticks.


58

The package of an assortment of dissimilarproducts, i.e., a multiunit package, as, forexample, a toilet water and a dusting powder in agift box, may bear:

A conventional ingredient declaration in whicheach ingredient of each product is identifiedunder an appropriate product heading, or

An alternate ingredient declaration in which thecolor additives of all products of the assortmentare integrated into a single composite list thatindicates that the list pertains to all products.

Please note that if the units of an assortment arecustomarily separated from the outer packagefor retail sale, the ingredients must also bedeclared on the label of each inside unit.


59

This example of a hypothetical assortment ofdissimilar products consisting of a toilet waterand a dusting powder illustrates on the right sidethe alternate ingredient labeling option in whichall color additives are declared in a singlecomposite list. The declaration advises that thecolor additives pertain to both products.

If, for example, Red 40 or Blue 1 were present inboth products, they would have to be listed onlyonce in the declaration.


60

An assortment of products of similar compositionand intended for the same use in a package witha total surface area available for labeling of 12square inches or more as, for example, twotoilet waters of different fragrance or color in agift set, may bear either:

A conventional ingredient declaration in whichthe ingredients of each product are identifiedunder appropriate product headings, listing eitherall the ingredients in descending order of pre-dominance according to §701.3(a) or listing theingredients according to §701.3(f), declaring firstin descending order the ingredients other thancolors present at concentrations exceeding 1%,followed in any order by the ingredients otherthan color present at concentrations of 1% orless, followed in any order by the color additivespresent at any concentration, or

An alternate ingredient declaration, listing:

1. The ingredients other than colors commonto all products in cumulative descendingorder of predominance according to§701.3(a), or according to §701.3(f)[permitting listing of ingredients present at1% or less in any order], followed by

2. The ingredients other than colors notcommon to all products, identified by theproducts in which they are present,followed by

3. The color additives of all products withoutidentification of the products in which theyare present.


61

An assortment of products similar in compositionand intended for the same use in a package witha total surface area available for labeling of lessthan 12 square inches as, for example, severaleye shadows in a compact, may bear either:

A conventional ingredient declaration in whichthe ingredients of each product are identifiedunder appropriate product headings, listing eitherall the ingredients in descending order of pre-dominance according to §701.3(a) or listing theingredients according to §701.3(f), declaring firstin descending order the ingredients other thancolors present at concentrations exceeding 1%,followed in any order by the ingredients otherthan color present at concentrations of 1% orless, followed in any order by the color additivespresent at any concentration,

or

An alternate ingredient declaration listing theingredients of all products in a single integratedlist in cumulative descending order of predomi-nance according to §701.3(a) or cumulativelyaccording to §701.3(f).


62

This example of an assortment consisting of twosimilar hypothetical eye shadow formulationsdemonstrates the optional ingredient declara-tions for packages with a total surface areaavailable for labeling of 12 square inches ormore (center) and for packages with a totalsurface area available for labeling of less than12 square inches (right side).

On the left side are shown two conventionalingredient declarations, each representing oneshade.

In the center is shown the integrated ingredientdeclaration for the two shades in the packagewith 12 square inches or more of availablelabeling area. Note that the ingredients otherthan colors not common to all products are listedafter the ingredients that are common and areindentified by the products in which they areused. (Bentonite in Blue Shade, Lanolin inGreen Shade.)

On the right side is shown the integratedingredient declaration for the two shades in thepackage with less than 12 square inches ofavailable labeling area. Note that the ingredientsnot common to all formulations need not beidentified by the products in which they are used.


63

According to §§701.3(g)(2) and (o)(3), a brandedshade line may be defined as a line of individu-ally packaged eye or facial make-up cosmeticsor nail enamels bearing a label that is sharedwith other products, i.e., bearing the sameproduct name. Example: A line of lipsticks withthe same brand name.

According to §§701.3(g)(2) and (o)(4), a brandedshade line assortment may be defined as severalassortments of eye or facial make-up cosmeticsor nail enamels in packages bearing the samelabel. Example: Several compacts with the samename and label, each containing several eyeshadows.


64

Branded shade lines and branded shade lineassortments may bear either:

A conventional ingredient declaration for eachproduct in which the ingredients of each productare identified in descending order of predomi-nance according to §701.3(a) or, alternately,according to §701.3(f) [in the case of anassortment the ingredients may be declaredcumulatively in a single list for each assortmentaccording to §§701.3(a) or (f)]

or

An alternate ingredient declaration listing allingredients for all branded shades in the cumula-tive order shown below. In this case, each shadeof a branded shade line or each package of abranded shade line assortment bears the sameingredient declaration.


65

This example of a hypothetical shade of a line oflipsticks bearing the same brand name illustratesthree common errors found in cosmetic ingredi-ent declarations, namely:

1. Proprietary mixtures of ingredients identifiedin the ingredient dictionary by a parenthetical“(and)” are often declared on the label asshown in the dictionary section listing chemi-cal/trade names and their respective labelnames. The compounds of such mixturesmust be separated, the “(and)” omitted, andthe components treated as individual ingredi-ents for labeling purposes. See “Mica (and)Titanium dioxide (and) Iron oxides.”

2. Many labels list all color additives of a shadeline after the phrase “May contain.” The coloradditives common to all shades must belisted before “May contain”, and only thosenot found in all shade formulations may belisted after “May contain.”

3. The ingredients other than colors which arenot included in all shade formulations must beidentified as to the shades in which they arepresent.


66

Direct mail cosmetics may utilize off-packageingredient labeling as an alternative to thedeclaration of ingredients on an informationpanel.

For the purpose of cosmetic ingredient labeling,direct mail cosmetics are defined as cosmeticsordered by mail and delivered to consumersthrough the mail without the involvement of anintermediary sales agent.

Cosmetics sold to customers through “door-to-door” salespersons are not considered directmail cosmetics even though they may be deliv-ered to consumers directly by mail.


67

As an alternative to the declaration of ingredientson an information panel, the declaration mayappear in letters not less than 1/16 of an inch inheight in:

Labeling that accompanies and specificallyrelates to the cosmetic(s) mailed, e.g., brochure,insert or written directions for safe use, or

Labeling furnished to each consumer for per-sonal use and from which cosmetics are orderedthrough the mail, e.g., a direct mail sales catalogor brochure.


68

If the ingredients of cosmetics distributed toconsumers by direct mail are made availablethrough off-package labeling, the followingrequirements must be met:

1. The package mailed to consumers must beaccompanied by a notice in 3/16 of an inchlettering informing the consumer of thelocation of the ingredient declaration(s), of thename and address of the mail order distribu-tor, and that a copy of the ingredientdeclaration(s) will be mailed to any personrequesting it.

2. The mail order distributor must promptly maila copy of an ingredient declaration to anyperson requesting it.

3. The notice in 3/16 of an inch in lettering mustbe located on, or affixed to, the top of thepackage; or it must be inside the package ontop of the contents or on the face of theplatform surrounding and holding theproduct(s) and must be readily visible to theconsumer on opening.

4. The ingredient declarations must beconspicuous and presented in a way that theconsumer can readily associate each ingredi-ent with each cosmetic.


69

The declaration of ingredients in labeling accom-panying a cosmetic, i.e., off-package ingredientlabeling, requires that:

1. The product is not enclosed in an outercontainer.

2. The total package surface area is less than12 square inches, and

3. The products are held for sale in tightlycompartmented trays or racks.

The ingredient declaration must be in letters notless than 1/16 of an inch in height and mayappear on padded sheets, leaflets or similarlabeling accompanying the product.

Products which are not eye or facial make-upcosmetics or nail enamels must be displayed forsale in tightly compartmented trays or racks of adisplay unit. The holder of the padded sheets orleaflets bearing the ingredient declaration(s)must be attached to the display unit.

Products which are eye or facial make-upcosmetics or nail enamels may be held for salein tightly compartmented trays or racks locatedbelow the sales counter. The holder of theingredient labeling must be attached to a displaychart which bears samples of the productshades and is displayed to purchasers.


70

Among the various conditions described in§§701.3(j) and (k) that must be met if off-package ingredient labeling utilized as analternative to the declaration of ingredients on aninformation panel, the following deserve particu-lar attention:

1. The display unit or chart must bear thestatement “Federal law requires ingredientlists to be displayed here” in letters not lessthan 3/16 of an inch in height. This statementbecomes conspicuous when the last ingredi-ent list has been taken or may also be shownat all times adjacent to the holder of labelingbearing the ingredient declaration(s).


71

2. The holder of off-package cosmetic ingredientlabeling, e.g., padded sheets or leaflets, mustbe attached to the display unit or chart so thatthe labeling is in front of the display unit orchart and can be read in full by a purchaserfacing the display under customary conditionsof retail sale.

As an alternative to full display of off-packageingredient labeling, the labeling may also be onthe side of the display unit or chart, but not at thetop, back or bottom, in which case it must beaccompanied by a conspicuous notice in 3/16 ofan inch lettering on the front of the display unit,describing the location of the off-packagelabeling and stating “Federal law requiresingredient lists to be displayed here.”


72

The following additional conditions must be metto comply with the requirements for off-packageingredient labeling of cosmetics:

1. The padded sheets or leaflets attached to thedisplay unit or chart must declare the ingredi-ents of all products sold with the display.

2. padded sheets or leaflets must beidentical.


73

3. The number of copies of padded sheets orleaflets provided with each shipment of acosmetic must be sufficient so that eachpurchaser may obtain a copy of an ingredientdeclaration. Further, the display units andreplacement labeling must be accompaniedby appropriate instructions to the retailer toassure that retailers display the paddedsheets or leaflets.

4. Shipments of refill items also must be accom-panied by sufficient copies of ingredientdeclarations, and the container holding therefill items and the respective copies ofingredient declarations must not contain othercosmetic products.


74

5. The firm engaged in off-package cosmeticingredient labeling must promptly mail a copyof the ingredient declaration to any personrequesting it.

6. In case of a formulation change, the newpadded sheet or leaflet must be dated if notshipped together with the display unit or chart.If a padded sheet or leaflet is to be used inconjunction with the old and the new formula-tions, it must bear both ingredient declara-tions, and the declarations must be identifiedin a way that the purchaser can determine inwhich declaration pertains to which product.As an alternative, the padded sheet or leafletbearing the two ingredient declarations mayadvise the purchaser that the formulation hasbeen changed and that either declaration maybe applicable.


Sunscreen Products Supplementto

FDA-ICMADSimplified Guide

to Cosmetic Labeling

*Based upon the TFM (Tentative Final Monograph)published in the Federal Register, May 12, 1993.

The following attempts to simplify theTFM on Sunscreens for a general

understanding of the proposed rules.

Compiled by: ICMAD Technical CommitteeHoward Baker, ChairmanEugene Frank, Ph.D.Maurice Siegel, Ph.D.Charles SchochSanford Salzman

Edited by: Penni Jones, Executive DirectorJerome N. Michell, ICMAD Executive Director EmeritusSheila Sebor, ICMAD Associate Executive Director

September, 1996

75


This is a guide for compliance with the most recent Tentative Final Monograph; Proposed Rulefor sunscreen products as published in the Federal Register, Vol 58, No. 90, pp 28194-28296.21 CFR Part 352 et al., May 12, 1993.

The actual regulations should be reviewed and understood along with the information in this guide.Label copy should be evaluated by the FDA according to their normal review process or bycompetent legal council to ensure compliance.Although the contents of this guide are believed to be accurate, they have not been reviewedby the FDA and may not agree with their interpretation of the regulations.

Other labeling regulations for consumer products apply and should also be consulted.This guide should be considered as an aid for those already familiar with labeling regulations.It is not an exhaustive legal treatment of all labeling considerations for sunscreens.

The Tentative Final Monograph, Proposed Rule has several requirements for sunscreen products.Additional statements are explicitly mentioned and allowed by the Monograph.These requirements and additional statements are grouped in the following categories:

Principal Display Panel Requirements - SPF Statements Outer and inner container labelsStatement of Identity Outer and inner container labelsIndications General locationAdditional Indications General locationWarnings Outer and inner container labelsDirections Outer and inner container labelsStatement on Product Performance General locationActive Ingredients Outer and inner container labelsExpiration Dating Outer and inner container labels

OTC DRUG PRODUCT LABELINGSUNSCREEN PRODUCTS

76

ICMAD Sunscreen Products Supplement




STATEMENT OF IDENTITY PRINCIPAL DISPLAY PANEL Both inner and outer packages

Identifies the product as a sunscreen

A statement of the appropriate SPF value or values must appear on the inner and outerPrincipal Display Panels as shown below:

Labeling for Sunscreen Products which are NOT “water resistant” or “very water resistant”

“SPF = (insert tested SPF value)”

Labeling for Sunscreen Products which satisfy the “water resistant” sunscreen product testing procedures.

“Water Resistant.”

“SPF= (insert SPF value before sweating or going into the water.” before water orresistant testing perspiring

“SPF+ (insert SPF value after 40 minutes of sweating or activity in the water.” resulting from water or

resistant testing) perspiring

Labeling for Sunscreen Products which satisfy the “very water resistant” sunscreen product testing procedures.

“Very Water Resistant.”

“SPF= (insert SPF value before sweating or going into the water.” before water orresistant testing perspiring

“SPF= (insert SPF value sweating or activity in the water.”resulting from very or water resistant perspiring

testing

77




INDICATIONS General location

Labeling should contain a section headed as “Indications”

Choose any of the statements below, “as appropriate.”

“Sunscreen to help prevent sunburn.”

“Filters out the sun’s burning rays to prevent sunburn.” or orscreens harsh and often harmful

“Allows you to stay in the sun up to (insert SPF value) times longer than withoutsunscreen protection.”

“Provides up to (insert SPF value) times your natural protection from sunburn.”

“Filters out the sun’s rays to help prevent lip damage.” or or and/orscreens sun’s harsh rays skin damage

or and/or sun’s harmful rays freckling

and/or uneven coloration

“Protects from the harmful rays of the sun to help prevent lip damage.” or or and/orShields from the sun skin damage

and/or freckling and/or

uneven coloration

78




ADDITIONAL INDICATIONS General locationIn addition to the “indications” statement or statementsthe following may also be used:

For products with sunscreen actives that products an SPF of 2 to under 4 --

“Provides minimal protection against sunburn.” orProvides minimum

or Minimal

or Minimum

“Prolongs exposure time before sunburn occurs.”

“Permits tanning and reduces chance of sunburning.” or or

suntanning minimizes

“Helps prevent sunburn on limited exposure of untanned skin.”

“Helps to protect the skin against sunburn while permitting tanning.”

For products with sunscreen actives that produce an SPF of 4 to under 8 --

“Provides moderate protection against sunburn.”or

Moderate


“Permits tanning and reduces chances of sunburning.” or or


“Helps prevent sunburn on moderate exposure of untanned skin.”

79



ADDITIONAL INDICATIONS (Continued)

For products with sunscreen actives that produce and SPF of 8 to under 12 --

“Provides high protection against sunburn.” orHigh


“Permits tanning and reduces chance of sunburning.” or or


“Helps prevent sunburn.”

“For sun-sensitive skin.”

“High protection against sunburn for blondes, redheads, and fairskinned persons.”


“Provides very high protection against sunburn.”or

Very high

“Prevents sunburn and limits tanning.”

“For sun-sensitive skin.”

“Very high protection against sunburn for blondes, redheads, and fairskinned persons.”


“Reflects the burning rays of the sun.”


80


81



WARNINGS Outer and inner package labeling

Labeling must contain a section headed “Warnings:”

The following statements must appear:

i “For external use only, not be be swallowed.”

ii “Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.”

iii “Discontinue use if signs of irritation or rash appear. If irritation or rash persists, consult a doctor.”

Products which are lipsticks or lip balms do not have to list warning (i) above.

Products which are lipstick do not have to list warning (i) or (ii) above.


82



DIRECTIONS Outer and inner package labeling

Labeling must contain a section headed “Directions:”More detailed directions specific to the product formulation may be included as well.

All following statements must appear:

Labeling for Sunscreen Products which are NOT “water resistant” or “very water resistant”

“Adults and children 6 months of age and over: Apply liberally before sun exposure.and/orgenerouslyand/orsmoothlyand/orevenly

Reapply after swimming, excessive sweating or anytime after towel drying. orperspiring

Children under 2 years of age should use sunscreen products with a minimum SPF of 4.Children under 6 months of age: consult a doctor.”

Labeling for Sunscreen Products which satisfy the “water resistant” testing procedures.

“Adults and children 6 months of age and over: Apply liberally (insert appropriate timeand/or interval, if a waitinggenerously period is neededand/orsmoothlyand/orevenly

before sun or water exposure.

Reapply after 40 minutes of swimming or excessive sweating or anytime afteror towel drying.perspiring

Children under 2 years of age should use sunscreen products with a minimum SPF of 4.Children under 6 months of age: consult a doctor.”



83


DIRECTIONS (Continued)

Labeling for Sunscreen Products which satisfy the “very water resistant” testing procedures.

“Adults and children 6 months of age and over: Apply liberally (insert appropriateand/or time interval, if agenerously waiting periodand/or is needed)smoothlyand/orevenly

before sun or water exposure.

Reapply after 80 minutes of swimming or excessive sweating or anytime afteror towel drying.

perspiring

Children under 2 years of age should use sunscreen products with a minimum SPF of 4.

Children under 6 months of age: consult a doctor.”



84


STATEMENT ON PRODUCT PERFORMANCE General location


“Minimal Sun Protection Product.”


“Moderate Sun Protection Product.”


“ High Sun Protection Product.”

For products with sunscreen actives that produce an SPF to 12 to under 20 --

“Very High Sun Protection Product.”

For products with sunscreen actives that produce an SPF of 20 to 30 --

“Ultra High Sun Protection Product.”



85


STATEMENT ON PRODUCT PERFORMANCE (Continued)

Labeling for Sunscreen Products which satisfy the “water resistant” testing procedures.

“Retains its sun protection for at least 40 minutes in the water.”

“Resists removal by sweating. “ orperspiring.

“Sweat resistant.” orPerspiration

Labeling for Sunscreen Products which satisfy the “very water resistant” testing procedures.

“Retains its sun protection for at least 80 minutes in the water.”

“Resists removal by sweating. “ orperspiring.

“Sweat resistant.” orPerspiration




86

STATEMENT ON PRODUCT PERFORMANCE (Continued)

The following compilation of skin types and SPF’s “shall be appropriately included in labeling as a guide.”

Recommended Sun ProtectionSunburn tanning history product

Always burns easily; rarely tans. SPF 20 to 30

Always burns easily; tans minimally SPF 12 to under 20

Burns moderately; tans gradually SPF 8 to under 12

Burns minimally; always tans well SPF 4 to under 8

Rarely burns; tans profusely. SPF 2 to under 4

Products with an SPF of 12 to 30 containing titanium dioxide may use the following statement:

“Sunblock:”

The following statement shall be used:

“SUN ALERT: The sun causes skin damage. Regular use of sunscreens over theyears may reduce the chance of skin damage, some types of skin cancer, andother harmful effects due to the sun.”

Any variation of the statement that does not relate skin aging or skin cancer as being “due to the sun”will cause the product to be misbranded.

The word physician may replace the word doctor in any of the labeling statements.


87

Federal Register / Vol. 58, No. 90 / Wednesday, May 12, 1993 / Proposed Rules 28295

ACTIVE INGREDIENTS: Below isthe actual notice from the FederalRegister listing sunscreen activeingredients and permitted com-binations of active ingredients.

Subpart B--Active Ingredients

§352.10 Sunscreen active ingredients.The active ingredient of the product

consists of any of the following whenused in the concentration establishedfor each ingredient, and the finishedproduct provides a minimum sunprotection factor value of not less than2 as measured by the testing proceduresestablished in subpart D of this part:

(a) Aminobenzoic acid up to 15percent.

(b) Cinoxate up to 3 percent.(c) Diethanolamine

methoxycinnamate up to 10 percent.(d) Digalloyl trioleate up to 5 percent.(e) Dioxybenzone up to 3 percent.(f) Ethyl 4-[bis(hydroxypropyl)]

aminobenzoate up to 5 percent.(g) Glyceryl amiinobenzoate up to 3

percent.(h) Homosalate up to 15 percent.(i) Lawsone up to 0.25 percent with

dihydroxyacetone up to 3 percent.(j) Menthyl anthranilate up to 5

percent.(k) Octocrylene up to 10 percent.(l) Octyl methoxycinnamate up to 7.5

percent.(m) Octyl salicylate up to 5 percent.(n) Oxybenzone up to 6 percent.(o) Padimate O up to 8 percent.(p) Phenylbenzimidazole sulfonic

acid up to 4 percent(q) Red petrolatum up to 100 percent.(r) Sulisobenzone up to 10 percent.(s) Titanium dioxide up to 25 percent.(t) Trolamine salicylate up to 12

percent.

§352.20 Permitted combinations of activeingredients.

(a) Combinations of sunscreen activeingredients.

(1) Two or more sunscreen activeingredients identified in §352.10 may

be combined when used in theconcentrations established for eachingredient in paragraph (a) (2) of thissection and the finished product has aminimum sun protection factor value ofnot less than 2 as measured by thetesting procedures established insubpart D of this part

(2) Sunscreen active ingredients shallbe used within the following concentra-tions when used in combination withanother sunscreen or when the combina-tion is used with any other permittedactive ingredient:

(i) Aminobenzoic acid 5 to 15 percent.(ii) Cinoxate 1 to 3 percent.(iii) Diethanolamine methoxycinnamate

8 to 10 percent.(iv) Digalloyl trioleate 2 to 5 percent.(v) Dioxybenzone 3 percent.(vi) Ethyl 4-[bis(hydroxypropyl)]

aminobenzoate 1 to 5 percent.(vii) Glyceryl aminobenzoate 2 to 3

percent.(viii) Homosalate 4 to 15 percent.(ix) Lawsone 0.25 percent with

dihydroxyacetone 3 percent.(x) Menthyl anthranilate 3.5 to 5

percent.(xi) Oxtocrylene 7 to 10 percent.(xii) Octyl methoxycinnamate 2.0 to

7.5 percent.(xiii) Octyl salicylate 3 to 5 percent.(xiv) Oxybenzone 2 to 6 percent.(xv) Padimate O 1.4 to 8 percent.(xvi) Phenylbenzimidazole sulfonic

acid 1 to 4 percent.(xvii) Red petrolatum 30 to 100

percent.(xviii) Sulisobenzone 5 to 10 percent.(xix) Titanium dioxide 2 to 25 percent.(xx) Trolamine salicylate 5 to 12

percent.(b) Sunscreen and skin protectant

combinations.(1) Any single sunscreen active

ingredient when used in the concentrationestablished in §352.10 may be combinedwith one or more skin protectant activeingredients identified in §347.10 (a), (d),(e), (f), (h), (i), and (j) of this chapter,provided the finished products has aminimum SPF value of not less than 2 asmeasured by the testing procedures

established in Subpart D of this part andprovided the product is labeled accord-ing to §352.60.

(2) Two or more sunscreen activeingredients when used in the concentra-tions established in §352.20 (a) (2) maybe combined with one or more skinprotectant active ingredients identified in§347.10 (a), (d), (e), (f), (h), (i), and (j)of this chapter, provided the finishedproducts has a minimum SPF value ofnot less than 2 as measured by thetesting procedures established in subpartD of this part and provided the productsis labeled according to §352.60.

(c) For sunscreen and skin bleachingcombinations. See §358.50 of thischapter.


88

INDEXPAGE NO.

AAerosols 30,31

BBranded Shade Lines 63-65

CColor Additives for Matching 53,54Color Additives 39Consumer commodity, Definition 9Cosmetic, Definition 6Cosmetics which are also drugs, Definition 8Cosmetics which are also drugs 51,52

DDirect Mail Cosmetics, Declaration of Ingredients 67Direct Mail Cosmetics, Definition 66Direct Mail Cosmetics, Off-package Labeling 68-74

FFair Packaging & Labeling Act 2FDA Offices 90,91Feminine Deodorant Sprays 32Flavors 40Foaming Detergent Bath Products 33Food, Drug and Cosmetic Act 1Fragrances 40

IICMAD Office Back CoverIdentification of Ingredients 36Incidental Ingredients 55Index 88,89Ingredient Labeling, General Requirements 34Ingredient Labeling, Order of Declaration 37,38Ingredient Labeling, Prominence 35Ingredient Labeling, Type Size 35Intended Use, Definition 7

LLabel, Definition 11Labeling, Definition 12Language 19Laws regulating cosmetics 1,2


89

PAGE NO.MMetric Units in Net Contents 26Misbranding, Definition 3-5Multiunit/Multicomponent Packages, Definitions 56Multiunit/Multicomponent Packages, Dissimilar Products 57-59Multiunit/Multicomponent Packages, Similar Products 60-62

NName and Place of Business 22

PPackage, Definition 10PDP, Inner Container 16PDP, Outer Container 15PDP, Placement and Size 14Principal Display Panel (PDP), Definition 13Prominence and Conspicuousness 17,18

QQuantity of Contents 23-27

RRequesting Trade Secrecy 43

SStatement of Identity 21

TTrade Secret, Definition 42Trade Secret, Ingredients 41Trade Secrets, Determining Status 46-48Trade Secrets, Exemption from Labeling 44,45Trade Secrets, Requesting Exemption 49,50Type Size 20

UUnsubstantiated Safety 29

WWarning Statements, General Requirements 28

SUNSCREEN SUPPLEMENT 75-87


COSMETIC RESOURCES

Linda Katz, M.C., DirectorOffice of Cosmetics and ColorsUniversity Station, 4300 River RoadCollege Park, MD 20740(301)436-1130

Stanley Milstein, Ph.D., Special Assistant(301)436-1373

Catherine J. Bailey, (Acting) DirectorDivision of Cosmetics and Compliance(301)436-1130

Raymond Decker, DirectorDivision of Color Certification and Technology(301)436-1108

Charles HaynesConsumer Safety Officer301-436-1126

FDA Website: www.fda.gov(click on cosmetic icon)

90


91

FDA DISTRICT OFFICESListed below are FDA District office contacts that can be of assistance to you with your questions concern-ing FDA’s legal requirements, policies and approaches as they apply to cosmetic products. The telephonenumbers below are for the District office in your location. The FDA’s website can be accessed atwww.fda.gov and then click on the cosmetics icon.

Northeast Region (covers MA,ME, VT, NY, NH RI and CT)

Regional Office158-15 Liberty Ave.Jamaica, NY 11433718-340-7000, F: 718-662-5434

MA, ME, NH, VT, RI, CTOne Montvale Ave., 4th FloorStoneham, MA 02180781-596-7725, F: 781-596-7894

NY (City & Long Island)158-15 Liberty Ave.Jamaica, NY 11433718-340-7000, F: 718-662-5434

NY (Statewide)300 Pearl St., Suite 100Buffalo, NY 14202716-551-4461, F: 716-551-4470

Central Region (covers PA,OH, NJ, MD, WV, VA, KY, IL,IN, MI, WI, MN, SD, ND andDC)

Regional Office-PhiladelphiaPA, DEU.S. CustomshouseRoom 9002nd and Chestnut Sts.Philadelphia, PA 19106215-597-4390F: 215-597-5798

Regional Office-Chicago20 N. Michigan Ave.Suite 510Chicago, IL 60602312-596-6520, F: 312-886-1682

MD, VA, WV, DC6000 Metro Drive, Suite 101Baltimore, MD 21215410-779-5454 F: 410-779-5707

NJWaterview Corporate Center10 Waterview Blvd., 3rd FloorParsippany, NJ 07054973-526-6001, F: 973-526-6069

Central Region (Cont.)

OH, KY6751 Steger Dr.Cincinnati, OH 45237-3097513-679-2700, F: 513-679-2771

IL550 W. Jackson Blvd.,Suite 1500 SouthChicago, IL 60661312-353-5863. F: 312-596-4170

IN, MI300 River Place, Suite 5900Detroit, MI 48807313-393-8100, F: 313-393-8105

MN, ND, SD, WI212 3rd Avenue SouthMinneapolis, MN 55401612-334-4100, F: 612-334-4134

Southeast Region (coversNC, SC, TN, FL, AL, MS, GA, LA,Puerto Rico, US Virgin Islands)

Regional OfficeNC, SC, GA60 Eighth St., NEAtlanta, GA 30309404-253-1169, F: 404-253-1202

FL555 Winderley Place, Suite 200Maitland, FL 32751407-475-4700, F: 407-475-4768

AL, TN, LA, MS297 Plus Park Blvd.Nashville, TN 37217615-781-5385, 5388F: 615-781-5383

Puerto Rico466 Fernandez Juncos Ave.San Juan, PR 00901-3223787-729-6842, F: 787-729-6851

Southwest Region (covers IA,MO, AR, NE, KS, OK, TX, WY,CO, NM and UT)

Regional OfficeTX, AR, OK4040 North Central ExpresswaySuite 900Dallas, TX 75204214-253-5200, F: 214-253-5318

IA, NE, MO, KS11630 W. 80th St.Lenexa, KS 66214-3340913-752-2144, F: 913-752-2111

CO, NM, UTP.O. Box 250876th & Kipling St., Bldg. 20,Denver Federal CenterDenver, CO 80225-0087303-236-3016, F: 303-236-9670

Pacific Region (covers HI, AK,MT, WA, OR, ID, CA, NV, AZ)

Regional Office1301 Clay St., Suite 1180-NOakland, CA 94612-5217510-637-3960, F: 510-637-3976

HI, NV, No. CA, Guam , Pacific1431 Harbor Bay ParkwayAlameda, CA 94502-7070510-337-6700, F: 510-337-6859

AZ, So. CA19701 FairchildIrvine, CA 92612-2506949-608-2900, F: 949-608-4417

AK, WA, ID, MT, OR22201 23rd Dr., SEBothell, WA 98021-4421425-483-4950. F: 425-483-4996

3/06


NOTES


INDEPENDENT COSMETIC MANUFACTURERS & DISTRIBUTORS, INC.

1220 W. Northwest Highway, Palatine, IL 60067-1803847-991-4499, 1-800-334-2623, FAX: 847-991-8161Website: www.icmad.org, E-mail: [email protected]

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