[Title 21 CFR 701.3]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter G - COSMETICS]
[Part 701 - COSMETIC LABELING]
[Subpart A - General Provisions]
[Sec. 701.3 - Designation of ingredients.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  7
  1996-04-01
  1996-04-01
  false
  
  701.3
  Sec. 701.3
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION,
    COSMETICS
    COSMETIC LABELING
    General Provisions
  


Sec. 701.3  Designation of ingredients.

    (a) The label on each package of a cosmetic shall bear a declaration 
of the name of each ingredient in descending order of predominance, 
except that fragrance or flavor may be listed as fragrance or flavor. An 
ingredient which is both fragrance and flavor shall be designated by 
each of the functions it performs unless such ingredient is identified 
by name. No ingredient may be designated as fragrance or flavor unless 
it is within the meaning of such term as commonly understood by 
consumers. Where one or more ingredients is accepted by the Food and 
Drug Administration as exempt from public disclosure pursuant to the 
procedure established in Sec. 720.8(a) of this chapter, in lieu of label 
declaration of identity the phrase ``and other ingredients'' may be used 
at the end of the ingredient declaration.
    (b) The declaration of ingredients shall appear with such prominence 
and conspicuousness as to render it likely to be read and understood by 
ordinary individuals under normal conditions of purchase. The 
declaration shall appear on any appropriate information panel in letters 
not less than \1/16\ of an inch in height and without obscuring design, 
vignettes, or crowding. In the absence of sufficient space for such 
declaration on the package, or where the manufacturer or distributor 
wishes to use a decorative container, the declaration may appear on a 
firmly affixed tag, tape, or card. In those cases where there is 
insufficient space for such declaration on the package, and it is not 
practical to firmly affix a tag, tape, or card, the Commissioner may 
establish by regulation an acceptable alternate, e.g., a smaller type 
size. A petition requesting such a regulation as an amendment to this 
paragraph shall be submitted pursuant to part 10 of this chapter.
    (c) A cosmetic ingredient shall be identified in the declaration of 
ingredients by:
    (1) The name specified in Sec. 701.30 as established by the 
Commissioner for that ingredient for the purpose of

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cosmetic ingredient labeling pursuant to paragraph (e) of this section;
    (2) In the absence of the name specified in Sec. 701.30, the name 
adopted for that ingredient in the following editions and supplements of 
the following compendia, listed in order as the source to be utilized:
    (i) CTFA (Cosmetic, Toiletry and Fragrance Association, Inc.) 
Cosmetic Ingredient Dictionary, Second Ed., 1977 (available from the 
Cosmetic, Toiletry and Fragrance Association, Inc. 1110 Vermont Ave. 
NW., Suite 800, Washington, DC 20005, or available for inspection at the 
Office of the Federal Register, 800 North Capitol Street, NW., suite 
700, Washington, DC 20408), which is incorporated by reference, except 
for the following deletions and revisions:
    (a) The following names are not adopted for the purpose of cosmetic 
ingredient labeling:

Acid Black 58
Acid Black 107
Acid Black 139
Acid Blue 168
Acid Blue 170
Acid Blue 188
Acid Blue 209
Acid Brown 19
Acid Brown 30
Acid Brown 44
Acid Brown 45
Acid Brown 46
Acid Brown 48
Acid Brown 224
Acid Orange 80
Acid Orange 85
Acid Orange 86
Acid Orange 88
Acid Orange 89
Acid Orange 116
Acid Red 131
Acid Red 213
Acid Red 252
Acid Red 259
Acid Violet 73
Acid Violet 76
Acid Violet 99
Acid Yellow 114
Acid Yellow 127
Direct Yellow 81
Solvent Black 5
Solvent Brown 43
Solvent Yellow 63
Solvent Yellow 90

    (b) The following names are adopted for the purpose of cosmetic 
ingredient labeling, provided the respective monographs are revised to 
describe their otherwise disclosed chemical compositions, or describe 
their chemical compositions more precisely, and such revised monographs 
are published in supplements to this dictionary edition by July 18, 
1980.

Acid Black 2
Benzophenone-11
Carbomer 934
Carbomer 934P
Carbomer 940
Carbomer 941
Carbomer 960
Carbomer 961
Chlorofluorocarbon 11S
Dimethicone Copolyol
Disperse Red 17
Pigment Green 7
Polyamino Sugar Condensate
SD Alcohol (all 27 alphanumeric designations)
Sodium Chondroitin Sulfate
Synthetic Beeswax

    (c) The following names are adopted for the purpose of cosmetic 
ingredient labeling until January 19, 1981.

Amphoteric (all 20 numeric designations)
Quaternium (all 49 numeric designations)

    (ii) United States Pharmacopeia, 19th Ed., 1975, and Second 
Supplement to the USP XIX and NF XIV, 1976. (Copies are available from 
the U.S. Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, 
Rockville, MD 20852, or available for inspection at the Office of the 
Federal Register, 800 North Capitol Street, NW., suite 700, Washington, 
DC 20408.)
    (iii) National Formulary, 14th Ed., 1975, and Second Supplement to 
the USP XIX and NF XIV, 1976. (Copies are available from the U.S. 
Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 
20852, or available for inspection at the Office of the Federal 
Register, 800 North Capitol Street, NW., suite 700, Washington, DC 
20408).
    (iv) Food Chemicals Codex, 2d Ed., 1972; First Supplement, 1974, and 
Second Supplement, 1975, which are incorporated by reference. Copies are 
available from the Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 200 C St. SW., Washington, DC 20204, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.
    (v) USAN and the USP dictionary of drug names, USAN 1975, 1961-1975

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cumulative list. (Copies are available from the U.S. Pharmacopeial 
Convention, Inc., 12601 Twinbrook Parkway, Rockville, MD 20852, or 
available for inspection at the Office of the Federal Register, 800 
North Capitol Street, NW., suite 700, Washington, DC 20408.)
    (3) In the absence of such a listing, the name generally recognized 
by consumers.
    (4) In the absence of any of the above, the chemical or other 
technical name or description.
    (d) Where a cosmetic product is also a drug, the declaration shall 
first declare the active drug ingredients as required under section 
502(e) of the Federal Food, Drug, and Cosmetic Act, and shall then 
declare the cosmetic ingredients.
    (e) Interested persons may submit a petition requesting the 
establishment of a specific name for a cosmetic ingredient pursuant to 
part 10 of this chapter. The Commissioner may also propose such a name 
on his own initiative.
    (f) As an alternative to listing all ingredients in descending order 
of predominance, ingredients may be grouped and the groups listed in the 
following manner and order:
    (1) Ingredients, other than color additives, present at a 
concentration greater than 1 percent, in descending order of 
predominance; followed by
    (2) Ingredients, other than color additives, present at a 
concentration of not more than 1 percent, without respect to order of 
predominance; followed by
    (3) Color additives, without respect to order of predominance. 
Ingredients specified in paragraph (f)(2) of this section may be 
included with those specified in paragraph (f)(1) of this section and 
listed in descending order of predominance.
    (g) A declaration of ingredients may include an ingredient not in 
the product if the ingredient is identified by the phrase ``may 
contain'' and:
    (1) It is a color additive added to some batches of the product for 
purposes of color matching; or
    (2)(i) The same declaration of ingredients is also used for other 
products similar in composition and intended for the same use, including 
products which may be assortments of products similar in composition and 
intended for the same use; and
    (ii) Such products are ``shaded'' products, i.e., those falling 
within the product categories identified in Sec. 720.4 (c)(3), (7) and 
(8)(v) of this chapter; and
    (iii) All products sharing the common declaration of ingredients are 
sold by the labeler under a common trade name or brand designation, and 
no trade name or brand designation not common to all such products 
appears in the labeling of any of them; and
    (iv) The ingredient is a color additive.
    (h) As an alternative to a declaration of color additive ingredients 
for each product, the color additives of an assortment of cosmetic 
products that are sold together in the same package may be declared in a 
single composite list in a manner that is not misleading and that 
indicates that the list pertains to all the products.
    (i) As an alternative to the declaration of ingredients specified in 
paragraph (b) of this section, the declaration of ingredients may appear 
in letters not less than \1/16\ of an inch in height in labeling 
accompanying the product, as for example, on padded sheets or in 
leaflets, if the total surface area of the package is less than 12 
square inches. This paragraph is inapplicable to any packaged cosmetic 
product enclosed in an outer container, e.g., a folding carton. In 
addition, this paragraph is applicable only to cosmetic products meeting 
one of the following requirements:
    (1) The cosmetic products are held and displayed for sale in tightly 
compartmented trays or racks of a display unit. The holder of the 
labeling bearing the declaration of ingredients shall be attached to the 
display unit; or
    (2) The cosmetic products are ``shaded'' products, i.e., those 
falling within the product categories identified in Sec. 720.4 (c)(3), 
(7) and (8)(v) of this chapter, and are held for sale in tightly 
compartmented trays or racks. The holder of the labeling bearing the 
declaration of ingredients shall be attached to a display chart bearing 
samples of the product shades, which is displayed to purchasers. Such a 
display chart shall be of such construction and design as to permit its 
continuous use

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as a display, such as on a counter, and shall be designed for the 
primary purpose of displaying samples of the shades of the products.
    (j) The holder of labeling bearing a declaration of ingredients and 
used in accordance with paragraph (i) of this section shall be attached 
to the display unit or chart and shall meet one of the following 
conditions:
    (1) The labeling is on the front of the display unit or chart and 
can be read in full by a purchaser facing the display unit or chart 
under customary conditions of retail sale; or
    (2) The labeling is on the front of the display unit or chart, is 
partially visible, and is accompanied by a conspicuous notice on the 
front of the display unit or chart describing the location of such 
labeling in letters not less than \3/16\ of an inch in height, e.g., 
``Ingredient lists above'', that can be read by a purchaser facing the 
display unit or chart under customary conditions of retail sale, or by 
the notice required by provisions in paragraph (k)(3) of this section, 
if conspicuous at all times; or
    (3) The labeling is on a side of the display unit or chart, but not 
on the top, back, or bottom, and is accompanied by a conspicuous notice 
on the front of the display unit or chart describing the location of 
such labeling in letters not less than \3/16\ of an inch in height, 
e.g., ``Ingredient lists located on right side of display'', that can be 
read by a purchaser facing the display unit or chart under customary 
conditions of retail sale.
    (k) Any use of a display unit or chart bearing labeling under the 
provisions of paragraph (i) of this section shall meet the following 
requirements:
    (1) All articles of labeling bearing ingredient declarations and 
used in conjunction with any one display unit or chart shall be 
identical and shall declare the ingredients of all products sold in 
conjunction with the display unit or chart for which the ingredient 
declaration is made pursuant to paragraph (i) of this section.
    (2) Any display unit or chart intended for such use shall be shipped 
together with the labeling intended to be attached to it.
    (3) Every display unit or chart and/or labeling system shall be 
designed so that the words ``Federal law requires ingredient lists to be 
displayed here'' in letters not less than \3/16\ of an inch in height 
(i) become conspicuous when no ingredient declarations are displayed and 
when the last list has been taken, or (ii) are conspicuous at all times 
adjacent to the place where ingredient declarations are to be attached.
    (4) Any labeling containing a declaration of ingredients which 
reflects a formulation change and not shipped accompanying a display 
unit or chart shall be dated. Whenever any formulation change is made, 
and the labeling containing the declaration of ingredients is thereby 
required to be used in conjunction with products of both the old and new 
formulations, the labeling shall declare the ingredients of both the old 
and new formulations separately in a way that is not misleading and in a 
way that permits the purchaser to identify the ingredient declaration 
applicable to each package, or which clearly advises the purchaser that 
the formulation has been changed and that either declaration may be 
applicable.
    (5) Sufficient copies of the declaration of ingredients shall be 
provided with each shipment of a cosmetic so that a purchaser may obtain 
a copy of the declaration with each purchase. Display units and 
replacement labeling for display units shall be accompanied by 
instructions to the retailer, which when followed will result in 
compliance with the requirements of this section. Copies of the 
declaration accompanying refills shall be attached to the specific 
refill items to which they pertain, or shall be packed with the specific 
refill items to which they pertain, in a container that does not contain 
other cosmetic products.
    (6) The firm whose name appears on a product pursuant to Sec. 701.12 
shall promptly mail a copy of the declaration of ingredients to any 
person requesting it.
    (7) The display unit or chart shall be designed and located such 
that the labeling is easily accessible to a purchaser facing the display 
unit or chart under customary conditions of retail sale.
    (l) The provisions of this section do not require the declaration of

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incidental ingredients that are present in a cosmetic at insignificant 
levels and that have no technical or functional effect in the cosmetic. 
For the purpose of this paragraph, incidental ingredients are:
    (1) Substances that have no technical or functional effect in the 
cosmetic but are present by reason of having been incorporated into the 
cosmetic as an ingredient of another cosmetic ingredient.
    (2) Processing aids, which are as follows:
    (i) Substances that are added to a cosmetic during the processing of 
such cosmetic but are removed from the cosmetic in accordance with good 
manufacturing practices before it is packaged in its finished form.
    (ii) Substances that are added to a cosmetic during processing for 
their technical or functional effect in the processing, are converted to 
substances the same as constituents of declared ingredients, and do not 
significantly increase the concentration of those constituents.
    (iii) Substances that are added to a cosmetic during the processing 
of such cosmetic for their technical and functional effect in the 
processing but are present in the finished cosmetic at insignificant 
levels and do not have any technical or functional effect in that 
cosmetic.
    (m) In the event that there is a current or anticipated shortage of 
a cosmetic ingredient, the declaration required by this section may 
specify alternatives to any ingredients that may be affected. An 
alternative ingredient shall be declared either (1) immediately 
following the normally used ingredient for which it substitutes, in 
which case it shall be identified as an alternative ingredient by the 
word ``or'' following the name of the normally used ingredient and any 
other alternative ingredient, or (2) following the declaration of all 
normally used ingredients, in which case the alternative ingredients in 
the group so listed shall be listed in expected descending order of 
predominance or in accordance with the provisions of paragraph (f) of 
this section and shall be identified as alternative ingredients by the 
phrase ``may also contain''. This paragraph is inapplicable to any 
ingredient mentioned in advertising, or in labeling other than in the 
declaration of ingredients required by this section.
    (n) In the event that the shortage of a cosmetic ingredient 
necessitates a formulation change, packages bearing labels declaring the 
ingredients of the old formulation may be used if the revised ingredient 
declaration appears (1) on a firmly affixed tag, tape, card, or sticker 
or similar overlabeling attached to the package and bearing the 
conspicuous words ``new ingredient list'' in letters not less than \1/
16\ of an inch in height, or (2) on labeling inside an unsealed package 
and the package bears the conspicuous words, on a sticker or similar 
overlabeling, ``new ingredient list inside'' in letters not less than 
\1/16\ of an inch in height.
    (o) The ingredients of products that are similar in composition and 
intended for the same use may be declared as follows:
    (1) The declaration of ingredients for an assortment of such 
products that are sold together in the same package, e.g., eyeshadows of 
different colors, may declare the ingredients that are common to all the 
products, in a single list in their cumulative order of predominance or 
in accordance with the provisions of paragraph (f) of this section, 
together with a statement, in terms that are as informative as 
practicable and that are not misleading, declaring the other ingredients 
and identifying the products in which they are present. The color 
additive ingredients of all the products in such an assortment, whether 
or not common to all the products, may be declared in a single composite 
list following the declaration of the other ingredients without 
identifying the products in which they are present.
    (2) The ingredients of an assortment of such products that are sold 
together in the same package, e.g., eyeshadows of different colors, may 
be declared in a single list in their cumulative order of predominance 
or in accordance with the provisions of paragraph (f) of this section, 
if the package is designed such that it has a total surface area 
available to bear labeling of less than 12 square inches. For the 
purpose of this paragraph, surface area is not available

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for labeling if physical characteristics of the package surface, e.g., 
decorative relief, make application of a label impractical.
    (3) The declaration of ingredients for such a product that is 
individually packaged and bears a label that is shared with other 
products pursuant to the provisions of paragraph (g)(2) of this section, 
e.g., one lipstick in a line of lipsticks, may declare the ingredients 
that are common to all such products, in a single list in their 
cumulative order of predominance or in accordance with the provisions of 
paragraph (f) of this section, together with a statement, in terms that 
are as informative as practicable and that are not misleading, declaring 
the other ingredients in such products, and identifying the products in 
which they are present. The color additive ingredients shall be declared 
in accordance with the provisions of paragraph (g) of this section.
    (4) The declaration of ingredients for an assortment of such 
cosmetic products that bears a label that is shared with other products 
pursuant to the provisions of paragraph (g)(2) of this section, e.g., 
one of several compacts in a line of compacts, may declare the 
ingredients that are common to all such products, in a single list in 
their cumulative order of predominance or in accordance with the 
provisions of paragraph (f) of this section, together with a statement, 
in terms that are as informative as practicable and that are not 
misleading, declaring the other ingredients in such products and 
identifying the products in which they are present. The color additive 
ingredients shall be declared in accordance with the provisions of 
paragraph (g) of this section.
    (p) As an alternative to the declaration of ingredients in letters 
not less than \1/16\ of an inch in height, letters may be not less than 
\1/32\ of an inch in height if the package is designed such that it has 
a total surface area available to bear labeling of less than 12 square 
inches. For the purpose of this paragraph, surface area is not available 
for labeling if physical characteristics of the package surface, e.g., 
decorative relief, make application of a label impractical.
    (q) The inside containers in a multiunit or multicomponent retail 
cosmetic package are not required to bear a declaration of ingredients 
when the labeling of the multiunit or multicomponent retail cosmetic 
package meets all the requirements of this section and the inside 
containers are not intended to be, and are not customarily, separated 
from the retail package for retail sale.
    (r) In the case of cosmetics distributed to the consumers by direct 
mail, as an alternative to the declaration of ingredients on an 
information panel, the declaration of ingredients may appear in letters 
not less than \1/16\ of an inch in height in labeling that accompanies 
and specifically relates to the cosmetic(s) mailed, or in labeling 
furnished to each consumer for his personal use and from which he orders 
cosmetics through the mail, e.g., a direct mail sales catalog or 
brochure, provided all of the following additional requirements are met:
    (1) The declarations of ingredients are conspicuous and presented in 
a way that permits the consumer to identify the declaration of 
ingredients applicable to each cosmetic.
    (2) The package mailed to the consumer is accompanied by a notice 
located on, or affixed to, the top of the package or on top of the 
contents inside the package, or on the face of the package platform 
surrounding and holding the product(s), readily visible to the consumer 
on opening of the package, and provides the following information in 
letters not less than \3/16\ of an inch in height:
    (i) The location of the declarations of ingredients, e.g., in an 
accompanying brochure, or in a sales catalog used for ordering;
    (ii) A statement that a copy of the declaration of ingredients will 
be mailed promptly to any person requesting it; and
    (iii) The name and place of business of the mail order distributor,
    (3) The mail order distributor promptly mails a copy of the

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declaration of ingredients to any person requesting it.

[39 FR 10056, Mar. 15, 1974, as amended at 40 FR 8922, Mar. 3, 1975; 40 
FR 18426, Apr. 28, 1975; 42 FR 4718, Jan. 25, 1977; 42 FR 15676, Mar. 
22, 1977; 42 FR 24255, May 31, 1977; 42 FR 46516, Sept. 16, 1977; 42 FR 
61257, Dec. 2, 1977; 45 FR 3577, Jan. 18, 1980; 47 FR 9397, Mar. 5, 
1982; 54 FR 24900, June 12, 1989]