136 

SUBCHAPTER G—COSMETICS 

PART 700—GENERAL 

Subpart A—General Provisions 

Sec. 

700.3 Definitions. 

Subpart B—Requirements for Specific 

Cosmetic Products 

700.11 Cosmetics containing bithionol. 

700.13 Use of mercury compounds in cosmetics including use as skinbleaching 

agents in cosmetic preparations also regarded as drugs. 

700.14 Use of vinyl chloride as an ingredient, 

including propellant of cosmetic aerosol 

products. 

700.15 Use of certain halogenated salicylanilides as ingredients in cosmetic products. 

700.16 Use of aerosol cosmetic products containing zirconium. 

700.18 Use of chloroform as an ingredient in 

cosmetic products. 

700.19 Use of methylene chloride as an ingredient of cosmetic products. 

700.23 Chlorofluorocarbon propellants. 

700.25 Tamper-resistant packaging requirements for cosmetic products. 

700.27 Use of prohibited cattle materials in 

cosmetic products. 

700.35 Cosmetics containing sunscreen ingredients. 

AUTHORITY: 21 U.S.C. 321, 331, 352, 355, 361, 

362, 371, 374. 

SOURCE: 39 FR 10054, Mar. 15, 1974, unless 

otherwise noted. 

Subpart A—General Provisions 

§ 700.3 Definitions. 

As used in this subchapter: 

(a) The term act means the Federal 

Food, Drug, and Cosmetic Act. 

(b) The term cosmetic product means a 

finished cosmetic the manufacture of 

which has been completed. Any cosmetic product which is also a drug or 

device or component thereof is also 

subject to the requirements of Chapter 

V of the act. 

(c) The term flavor means any natural or synthetic substance or substances used solely to impart a taste to 

a cosmetic product. 

(d) The term fragrance means any 

natural or synthetic substance or substances used solely to impart an odor 

to a cosmetic product. 

(e) The term ingredient means any 

single chemical entity or mixture used 

as a component in the manufacture of 

a cosmetic product. 

(f) The term proprietary ingredient 

means any cosmetic product ingredient 

whose name, composition, or manufacturing process is protected from competition by secrecy, patent, or copyright. 

(g) The term chemical description 

means a concise definition of the chemical composition using standard chemical nomenclature so that the chemical 

structure or structures of the components of the ingredient would be clear 

to a practicing chemist. When the composition cannot be described chemically, the substance shall be described 

in terms of its source and processing. 

(h) The term cosmetic raw material 

means any ingredient, including an ingredient that is a mixture, which is 

used in the manufacture of a cosmetic 

product for commercial distribution 

and is supplied to a cosmetic product 

manufacturer, packer, or distributor 

by a cosmetic raw material manufacturer or supplier. 

(i) The term commercial distribution of 

a cosmetic product means annual gross 

sales in excess of $1,000 for that product. 

(j) Establishment means a place of 

business where cosmetic products are 

manufactured or packaged. 

(k) The term manufacture of a cosmetic product means the making of 

any cosmetic product by chemical, 

physical, biological, or other procedures, including manipulation, sampling, testing, or control procedures 

applied to the product. 

(l) The term packaging of a cosmetic 

product means filling or labeling the 

product container, including changing 

the immediate container or label (but 

excluding changing other labeling) at 

any point in the distribution of the 

cosmetic product from the original 

place of manufacture to the person who 

makes final delivery or sale to the ultimate consumer. 


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Food and Drug Administration, HHS § 700.13 

(m) The term all business trading 

names used by the establishment means 

any name which is used on a cosmetic 

product label and owned by the cosmetic product manufacturer or packer, 

but is different from the principal 

name under which the cosmetic product manufacturer or packer is registered. 

(n) The definitions and interpretations contained in sections 201, 601, and 

602 of the act shall be applicable to 

such terms when used in the regulations in this subchapter. 

(o) System of commercial distribution of 

a cosmetic product means any distribution outside the establishment manufacturing the product, whether for sale, 

to promote future sales (including free 

samples of the product), or to gage consumer acceptance through market testing, in excess of $1,000 in cost of goods. 

(p) Filed screening procedure means a 

procedure that is: 

(1) On file with the Food and Drug 

Administration and subject to public 

inspection; 

(2) Designed to determine that there 

is a reasonable basis for concluding 

that an alleged injury did not occur in 

conjunction with the use of the cosmetic product; and 

(3) Which is subject, upon request by 

the Food and Drug Administration, to 

an audit conducted by the Food and 

Drug Administration at reasonable 

times and, where an audit is conducted, 

such audit shows that the procedure is 

consistently being applied and that the 

procedure is not disregarding reportable information. 

(q) Reportable experience means an experience involving any allergic reaction, or other bodily injury, alleged to 

be the result of the use of a cosmetic 

product under the conditions of use 

prescribed in the labeling of the product, under such conditions of use as are 

customary or reasonably foreseeable 

for the product or under conditions of 

misuse, that has been reported to the 

manufacturer, packer, or distributor of 

the product by the affected person or 

any other person having factual knowledge of the incident, other than an alleged experience which has been determined to be unfounded or spurious 

when evaluated by a filed screening 

procedure. 

[39 FR 10054, Mar. 15, 1974, as amended at 46 

FR 38073, July 24, 1981] 

Subpart B—Requirements for 

Specific Cosmetic Products 

§ 700.11 Cosmetics containing 

bithionol. 

(a) Bithionol has been used to some 

extent as an antibacterial agent in cosmetic preparations such as detergent 

bars, shampoos, creams, lotions, and 

bases used to hide blemishes. New evidence of clinical experience and 

photopatch tests indicate that 

bithionol is capable of causing 

photosensitivity in man when used 

topically and that in some instances 

the photosensitization may persist for 

prolonged periods as severe reactions 

without further contact with sensitizing articles. Also, there is evidence 

to indicate that bithionol may produce 

cross-sensitization with other commonly used chemicals such as certain 

halogenated salicylanilides and 

hexachlorophene. It is, therefore, the 

view of the Food and Drug Administration that bithionol is a deleterious substance which may render any cosmetic 

product that contains it injurious to 

users. Accordingly, any cosmetic containing bithionol is deemed to be adulterated under section 601(a) of the Federal Food, Drug, and Cosmetic Act. 

(b) Regulatory proceedings may be 

initiated with respect to any cosmetic 

preparation containing bithionol 

shipped within the jurisdiction of the 

act after March 15, 1968. 

§ 700.13 Use of mercury compounds in 

cosmetics including use as 

skinbleaching agents in cosmetic 

preparations also regarded as 

drugs. 

(a) Mercury-containing cosmetic 

preparations have been represented for 

many years as skin-bleaching agents or 

as preparations to remove or prevent 

freckles and/or brown spots (so-called 

age spots). Preparations intended for 

such use are regarded as drugs as well 

as cosmetics. In addition to such use as 

skin-bleaching agents, mercury compounds have also been widely used as 

preservatives in cosmetics such as 


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§ 700.14 21 CFR Ch. I (4–1–15 Edition) 

hand and body creams and lotions; hair 

shampoos, hair sets and rinses, hair 

straighteners, hair coloring, and other 

preparations; bath oils, bubble bath, 

and other bath preparations; makeup; 

antiperspirants and deodorants; and 

eye-area cosmetics. 

(b) The toxicity of mercury compounds is extensively documented in 

scientific literature. It is well known 

that mercury compounds are readily 

absorbed through the unbroken skin as 

well as through the lungs by inhalation 

and by intestinal absorption after ingestion. Mercury is absorbed from topical application and is accumulated in 

the body, giving rise to numerous adverse effects. Mercury is a potent allergen and sensitizer, and skin irritation 

is common after topical application. 

Cosmetic preparations containing mercury compounds are often applied with 

regularity and frequency for prolonged 

periods. Such chronic use of mercurycontaining skin-bleaching preparations 

has resulted in the accumulation of 

mercury in the body and the occurrence of severe reactions. Recently it 

has also been determined that microorganisms in the environment can convert various forms of mercury into 

highly toxic methyl mercury which has 

been found in the food supply and is 

now considered to be a serious environmental problem. 

(c) The effectiveness of mercury-containing preparations as skin-bleaching 

agents is questionable. The Food and 

Drug Administration has not been provided with well controlled studies to 

document the effectiveness of these 

preparations. Although mercurial preservatives are recognized as highly effective, less toxic and satisfactory substitutes are available except in the 

case of certain eye-area cosmetics. 

(d) Because of the known hazards of 

mercury, its questionable efficacy as a 

skin-bleaching agent, and the availability of effective and less toxic nonmercurial preservatives, there is no 

justification for the use of mercury in 

skin-bleaching preparations or its use 

as a preservative in cosmetics, with the 

exception of eye-area cosmetics for 

which no other effective and safe nonmercurial preservative is available. 

The continued use of mercurial preservatives in such eye-area cosmetics 

is warranted because mercury compounds are exceptionally effective in 

preventing Pseudomonas contamination 

of cosmetics and Pseudomonas infection 

of the eye can cause serious injury, including blindness. Therefore: 

(1) The Food and Drug Administration withdraws the opinion expressed 

in trade correspondence TC–9 (issued 

May 13, 1939) and concludes that any 

product containing mercury as a skinbleaching agent and offered for sale as 

skin-bleaching, beauty, or facial preparation is misbranded within the meaning of sections 502(a), 502(f)(1) and (2), 

and 502(j), and may be a new drug without approval in violation of section 505 

of the Federal Food, Drug, and Cosmetic Act. Any such preparation 

shipped within the jurisdiction of the 

Act after January 5, 1973 will be the 

subject of regulatory action. 

(2) The Food and Drug Administration withdraws the opinion expressed 

in trade correspondence TC–412 (issued 

Feb. 11, 1944) and will regard as adulterated within the meaning of section 

601(a) of the Act any cosmetic containing mercury unless the cosmetic 

meets the conditions of paragraph 

(d)(2) (i) or (ii) of this section. 

(i) It is a cosmetic containing no 

more than a trace amount of mercury 

and such trace amount is unavoidable 

under conditions of good manufacturing practice and is less than 1 part 

per million (0.0001 percent), calculated 

as the metal; or 

(ii) It is a cosmetic intended for use 

only in the area of the eye, it contains 

no more than 65 parts per million 

(0.0065 percent) of mercury, calculated 

as the metal, as a preservative, and 

there is no effective and safe nonmercurial substitute preservative available 

for use in such cosmetic. 

§ 700.14 Use of vinyl chloride as an ingredient, including propellant of 

cosmetic aerosol products. 

(a) Vinyl chloride has been used as an 

ingredient in cosmetic aerosol products 

including hair sprays. Where such aerosol products are used in the confines 

of a small room, as is often the case, 

the level of vinyl chloride to which the 


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Food and Drug Administration, HHS § 700.18 

individual may be exposed could be significantly in excess of the safe level established in connection with occupational exposure. Evidence indicates 

that vinyl chloride inhalation can result in acute toxicity, manifested by 

dizziness, headache, disorientation, and 

unconsciousness where inhaled at high 

concentrations. Studies also demonstrate carcinogenic effects in animals as a result of inhalation exposure 

to vinyl chloride. Furthermore, vinyl 

chloride has recently been linked to 

liver disease, including liver cancer, in 

workers engaged in the polymerization 

of vinyl chloride. It is the view of the 

Commissioner that vinyl chloride is a 

deleterious substance which may 

render any cosmetic aerosol product 

that contains it as an ingredient injurious to users. Accordingly, any cosmetic aerosol product containing vinyl 

chloride as an ingredient is deemed to 

be adulterated under section 601(a) of 

the Federal Food, Drug, and Cosmetic 

Act. 

(b) Any cosmetic aerosol product 

containing vinyl chloride as an ingredient shipped within the jurisdiction of 

the Act is subject to regulatory action. 

[39 FR 30830, Aug. 26, 1974] 

§ 700.15 Use of certain halogenated 

salicylanilides as ingredients in cosmetic products. 

(a) Halogenated salicylanilides (tribromsalan (TBS,3,4′,5–tribromosalicylanilide), dibromsalan (DBS,4′5–dibromosalicylanilide), metabromsalan 

(MBS, 3,5–dibromosalicylanilide) and 

3,3′,4,5′–tetrachlorosalicylanilide 

(TCSA)) have been used as antimicrobial agents for a variety of purposes in cosmetic products. These halogenated salicylanilides are potent 

photosensitizers and cross-sensitizers 

and can cause disabling skin disorders. 

In some instances, the 

photosensitization may persist for prolonged periods as a severe reaction 

without further exposure to these 

chemicals. Safer alternative antimicrobial agents are available. 

(b) These halogenated salicylanilides 

are deleterious substances which 

render any cosmetic that contains 

them injurious to users. Therefore, any 

cosmetic product that contains such a 

halogenated salicylanilide as an ingredient at any level for any purpose is 

deemed to be adulterated under section 

601(a) of the Federal Food, Drug, and 

Cosmetic Act. 

(c) Any cosmetic product containing 

these halogenated salicylanilides as an 

ingredient that is initially introduced 

into interstate commerce after December 1, 1975, that is not in compliance 

with this section is subject to regulatory action. 

[40 FR 50531, Oct. 30, 1975] 

§ 700.16 Use of aerosol cosmetic products containing zirconium. 

(a) Zirconium-containing complexes 

have been used as an ingredient in cosmetics and/or cosmetics that are also 

drugs, as, for example, aerosol antiperspirants. Evidence indicates that 

certain zirconium compounds have 

caused human skin granulomas and 

toxic effects in the lungs and other organs of experimental animals. When 

used in aerosol form, some zirconium 

will reach the deep portions of the 

lungs of users. The lung is an organ, 

like skin, subject to the development 

of granulomas. Unlike the skin, the 

lung will not reveal the presence of 

granulomatous changes until they have 

become advanced and, in some cases, 

permanent. It is the view of the Commissioner that zirconium is a deleterious substance that may render any 

cosmetic aerosol product that contains 

it injurious to users. 

(b) Any aerosol cosmetic product 

containing zirconium is deemed to be 

adulterated under section 601(a) of the 

Federal Food, Drug, and Cosmetic Act. 

(c) Any such cosmetic product introduced in interstate commerce after 

September 15, 1977 is subject to regulatory action. 

[42 FR 41376, Aug. 16, 1977] 

§ 700.18 Use of chloroform as an ingredient in cosmetic products. 

(a) Chloroform has been used as an 

ingredient in cosmetic products. Recent information has become available 

associating chloroform with carcinogenic effects in animals. Studies conducted by the National Cancer Institute have demonstrated that the oral 

administration of chloroform to mice 


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§ 700.19 21 CFR Ch. I (4–1–15 Edition) 

and rats induced hepatocellular carcinomas (liver cancer) in mice and 

renal tumors in male rats. Scientific 

literature indicates that chloroform is 

absorbed from the gastrointestinal 

tract, through the respiratory system, 

and through the skin. The Commissioner concludes that, on the basis of 

these findings, chloroform is a deleterious substance which may render injurious to users any cosmetic product 

that contains chloroform as an ingredient. 

(b) Any cosmetic product containing 

chloroform as an ingredient is adulterated and is subject to regulatory action 

under sections 301 and 601(a) of the 

Federal Food, Drug, and Cosmetic Act. 

Any cosmetic product containing chloroform in residual amounts from its 

use as a processing solvent during manufacture, or as a byproduct from the 

synthesis of an ingredient, is not, for 

the purpose of this section, considered 

to contain chloroform as an ingredient. 

[41 FR 26845, June 29, 1976] 

§ 700.19 Use of methylene chloride as 

an ingredient of cosmetic products. 

(a) Methylene chloride has been used 

as an ingredient of aerosol cosmetic 

products, principally hair sprays, at 

concentrations generally ranging from 

10 to 25 percent. In a 2-year animal inhalation study sponsored by the National Toxicology Program, methylene 

chloride produced a significant increase in benign and malignant tumors 

of the lung and liver of male and female mice. Based on these findings and 

on estimates of human exposure from 

the customary use of hair sprays, the 

Food and Drug Administration concludes that the use of methylene chloride in cosmetic products poses a significant cancer risk to consumers, and 

that the use of this ingredient in cosmetic products may render these products injurious to health. 

(b) Any cosmetic product that contains methylene chloride as an ingredient is deemed adulterated and is subject to regulatory action under sections 301 and 601(a) of the Federal 

Food, Drug, and Cosmetic Act. 

[54 FR 27342, June 29, 1989] 

§ 700.23 Chlorofluorocarbon propellants. 

The use of chlorofluorocarbons in 

cosmetics as propellants in self-pressurized containers is prohibited as provided in §2.125 of this chapter. 

[43 FR 11317, Mar. 17, 1978] 

§ 700.25 Tamper-resistant packaging 

requirements for cosmetic products. 

(a) General. Because most cosmetic 

liquid oral hygiene products and vaginal products are not now packaged in 

tamper-resistant retail packages, there 

is the opportunity for the malicious 

adulteration of those cosmetic products with health risks to individuals 

who unknowingly purchase adulterated 

products and with loss of consumer 

confidence in the security of cosmetic 

product packages. The Food and Drug 

Administration has the authority and 

responsibility under the Federal Food, 

Drug, and Cosmetic Act (the act) to establish a uniform national requirement 

for tamper-resistant packaging of cosmetic liquid oral hygiene products or 

products used vaginally that will improve the packaging security and help 

assure the safety of those products. 

Such a cosmetic product for retail sale 

that is not packaged in a tamper-resistant package or that is not properly 

labeled under this section is adulterated under section 601 of the act or 

misbranded under section 602 of the 

act, or both. 

(b) Requirement for tamper-resistant 

package. Each manufacturer and packer who packages a cosmetic liquid oral 

hygiene product or vaginal product for 

retail sale shall package the product in 

a tamper-resistant package, if this 

product is accessible to the public 

while held for sale. A tamper-resistant 

package is one having an indicator or 

barrier to entry which, if breached or 

missing, can reasonably be expected to 

provide visible evidence to consumers 

that tampering has occurred. To reduce 

the likelihood of substitution of a tamper-resistant feature after tampering, 

the indicator or barrier to entry is required to be distinctive by design (e.g., 

an aerosol product container) or by the 

use of an identifying characteristic 

(e.g., a pattern, name, registered trademark, logo, or picture). For purposes of 


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Food and Drug Administration, HHS § 700.25 

this section, the term ‘‘distinctive by 

design’’ means the packaging cannot be 

duplicated with commonly available 

materials or through commonly available processes. For purposes of this section, the term ‘‘aerosol product’’ 

means a product which depends upon 

the power of a liquified or compressed 

gas to expel the contents from the container. A tamper-resistant package 

may involve an immediate-container 

and closure system or secondary-container or carton system or any combination of systems intended to provide 

a visual indication of package integrity. The tamper-resistant feature 

shall be designed to and shall remain 

intact when handled in a reasonable 

manner during manufacture, distribution, and retail display. 

(c) Labeling. Each retail package of a 

cosmetic product covered by this section, except aerosol products as defined 

in paragraph (b) of this section, is required to bear a statement that is 

prominently placed so that consumers 

are alerted to the specific tamper-resistant feature of the package. The labeling statement is also required to be 

so placed that it will be unaffected if 

the tamper-resistant feature of the 

package is breached or missing. If the 

tamper-resistant feature chosen to 

meet the requirement in paragraph (b) 

of this section is one that uses an identifying characteristic, that characteristic is required to be referred to 

in the labeling statement. For example, the labeling statement on a bottle 

with a shrink band could say ‘‘For your 

protection, this bottle has an imprinted seal around the neck.’’ 

(d) Requests for exemptions from packaging and labeling requirements. A manufacturer or packer may request an exemption from the packaging and labeling requirements of this section. A request for an exemption is required to 

be submitted in the form of a citizen 

petition under §10.30 of this chapter 

and should be clearly identified on the 

envelope as a ‘‘Request for Exemption 

from Tamper-resistant Rule.’’ The petition is required to contain the following: 

(1) The name of the product. 

(2) The reasons that the product’s 

compliance with the tamper-resistant 

packaging or labeling requirements of 

this section is unnecessary or cannot 

be achieved. 

(3) A description of alternative steps 

that are available, or that the petitioner has already taken, to reduce the 

likelihood that the product will be the 

subject of malicious adulteration. 

(4) Other information justifying an 

exemption. 

This information collection requirement has been approved by the Office 

of Management and Budget under number 0910–0149. 

(e) Effective date. Cosmetic products 

covered by this section are required to 

comply with the requirements of this 

section on the dates listed below except 

to the extent that a product’s manufacturer or packer has obtained an exemption from a packaging or labeling requirement. 

(1) Initial effective date for packaging 

requirements. (i) The packaging requirement in paragraph (b) of this section is 

effective on Feburary 7, 1983 for each 

affected cosmetic product (except vaginal tablets) packaged for retail sale on 

or after that date, except for the requirement in paragraph (b) of this section for a distinctive indicator or barrier to entry. 

(ii) The packaging requirement in 

paragraph (b) of this section is effective on May 5, 1983 for each cosmetic 

product that is a vaginal tablet packaged for retail sale on or after that 

date. 

(2) Initial effective date for labeling requirements. The requirement in paragraph (b) of this section that the indicator or barrier to entry be distinctive 

by design and the requirement in paragraph (c) of this section for a labeling 

statement are effective on May 5, 1983 

for each affected cosmetic product 

packaged for retail sale on or after 

that date, except that the requirement 

for a specific label reference to any 

identifying characteristic is effective 

on February 6, 1984 for each affected 

cosmetic product packaged for retail 

sale on or after that date. 

(3) Retail level effective date. The tamper-resistant packaging requirement of 

paragraph (b) of this section is effective February 6, 1984 for each affected 

cosmetic product held for sale on or 

after that date that was packaged for 

retail sale before May 5, 1983. This does 


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§ 700.27 21 CFR Ch. I (4–1–15 Edition) 

not include the requirement in paragraph (b) of this section that the indicator or barrier to entry be distinctive 

by design. Products packaged for retail 

sale after May 5, 1983, as required to be 

in compliance with all aspects of the 

regulations without regard to the retail level effective date. 

[47 FR 50451, Nov. 5, 1982; 48 FR 1707, Jan. 14, 

1983; 48 FR 11427, Mar. 18, 1983, as amended at 

48 FR 16664, Apr. 19, 1983; 48 FR 37624, Aug. 19, 

1983] 

EFFECTIVE DATE NOTE: See 48 FR 41579, 

Sept. 16, 1983, for a document announcing an 

interim stay of the effective date of certain 

provisions in paragraph (e)(3) of §700.25. 

§ 700.27 Use of prohibited cattle materials in cosmetic products. 

(a) Definitions. The definitions and interpretations of terms contained in 

section 201 of the Federal Food, Drug, 

and Cosmetic Act (the act) apply to 

such terms when used in this part. The 

following definitions also apply: 

(1) Prohibited cattle materials means 

specified risk materials, small intestine of all cattle except as provided in 

paragraph (b)(2) of this section, material from nonambulatory disabled cattle, material from cattle not inspected 

and passed, or mechanically separated 

(MS) (Beef). Prohibited cattle materials do not include the following: 

(i) Tallow that contains no more 

than 0.15 percent insoluble impurities, 

tallow derivatives, hides and hide-derived products, and milk and milk 

products, and 

(ii) Cattle materials inspected and 

passed from a country designated 

under paragraph (e) of this section. 

(2) Inspected and passed means that 

the product has been inspected and 

passed for human consumption by the 

appropriate regulatory authority, and 

at the time it was inspected and 

passed, it was found to be not adulterated. 

(3) Mechanically Separated (MS)(Beef) 

means a meat food product that is finely comminuted, resulting from the mechanical separation and removal of 

most of the bone from attached skeletal muscle of cattle carcasses and 

parts of carcasses that meet the specifications contained in 9 CFR 319.5, the 

regulation that prescribes the standard 

of identity for MS (Species). 

(4) Nonambulatory disabled cattle 

means cattle that cannot rise from a 

recumbent position or that cannot 

walk, including, but not limited to, 

those with broken appendages, severed 

tendons or ligaments, nerve paralysis, 

fractured vertebral column, or metabolic conditions. 

(5) Specified risk material means the 

brain, skull, eyes, trigeminal ganglia, 

spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and 

lumbar vertebrae, and the wings of the 

sacrum), and dorsal root ganglia of cattle 30 months and older and the tonsils 

and distal ileum of the small intestine 

of all cattle. 

(6) Tallow means the rendered fat of 

cattle obtained by pressing or by applying any other extraction process to 

tissues derived directly from discrete 

adipose tissue masses or to other carcass parts and tissues. Tallow must be 

produced from tissues that are not prohibited cattle materials or must contain not more than 0.15 percent insoluble impurities as determined by the 

method entitled ‘‘Insoluble Impurities’’ 

(AOCS Official Method Ca 3a-46), American Oil Chemists’ Society (AOCS), 5th 

Edition, 1997, incorporated by reference 

in accordance with 5 U.S.C. 552(a) and 1 

CFR part 51, or another method equivalent in accuracy, precision, and sensitivity to AOCS Official Method Ca 3a46. You may obtain copies of the method from the AOCS (http://www.aocs.org) 

2211 W. Bradley Ave. Champaign, IL 

61821. Copies may be examined at the 

Center for Food Safety and Applied Nutrition’s Library, 5100 Paint Branch 

Pkwy., College Park, MD 20740, or at 

the National Archives and Records Administration (NARA). For information 

on the availability of this material at 

NARA, call 202–741–6030, or go to http:// 

www.archives.gov/federallregister/ 

codeloflfederallregulations/ 

ibrllocations.html. 

(7) Tallow derivative means any chemical obtained through initial hydrolysis, saponification, or transesterification of tallow; chemical conversion of material obtained by hydrolysis, saponification, or transesterification may be applied to obtain 

the desired product. 


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Food and Drug Administration, HHS § 700.35 

(b) Requirements. (1) No cosmetic 

shall be manufactured from, processed 

with, or otherwise contain, prohibited 

cattle materials. 

(2) The small intestine is not considered prohibited cattle material if the 

distal ileum is removed by a procedure 

that removes at least 80 inches of the 

uncoiled and trimmed small intestine, 

as measured from the caeco-colic junction and progressing proximally towards the jejunum, or by a procedure 

that the establishment can demonstrate is equally effective in ensuring complete removal of the distal 

ileum. 

(c) Records. (1) Manufacturers and 

processors of a cosmetic that is manufactured from, processed with, or otherwise contains, material from cattle 

must establish and maintain records 

sufficient to demonstrate that the cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials. 

(2) Records must be retained for 2 

years after the date they were created. 

(3) Records must be retained at the 

manufacturing or processing establishment or at a reasonably accessible location. 

(4) The maintenance of electronic 

records is acceptable. Electronic 

records are considered to be reasonably 

accessible if they are accessible from 

an onsite location. 

(5) Records required by this section 

and existing records relevant to compliance with this section must be available to FDA for inspection and copying. 

(6) When filing entry with U.S. Customs and Border Protection, the importer of record of a cosmetic manufactured from, processed with, or otherwise containing, cattle material must 

affirm that the cosmetic was manufactured from, processed with, or otherwise contains, cattle material and 

must affirm that the cosmetic was 

manufactured in accordance with this 

section. If a cosmetic is manufactured 

from, processed with, or otherwise contains, cattle material, then the importer of record must, if requested, provide within 5 days records sufficient to 

demonstrate that the cosmetic is not 

manufactured from, processed with, or 

does not otherwise contain, prohibited 

cattle material. 

(7) Records established or maintained 

to satisfy the requirements of this subpart that meet the definition of electronic records in §11.3(b)(6) of this 

chapter are exempt from the requirements of part 11 of this chapter. 

Records that satisfy the requirements 

of this subpart but that are also required under other applicable statutory 

provisions or regulations remain subject to part 11 of this chapter. 

(d) Adulteration. Failure of a manufacturer or processor to operate in 

compliance with the requirements of 

paragraph (b) or (c) of this section renders a cosmetic adulterated under section 601(c) of the act. 

(e) Process for designating countries. A 

country seeking designation must send 

a written request to the Director, Office of the Center Director, Center for 

Food Safety and Applied Nutrition, 

Food and Drug Administration, at the 

address designated in 21 CFR 5.1100. 

The request shall include information 

about a country’s bovine spongiform 

encephalopathy (BSE) case history, 

risk factors, measures to prevent the 

introduction and transmission of BSE, 

and any other information relevant to 

determining whether specified risk materials, the small intestine of cattle except as provided in paragraph (b)(2) of 

this section, material from nonambulatory disabled cattle, or MS 

(Beef) from cattle from the country 

should be considered prohibited cattle 

materials. FDA shall respond in writing to any such request and may impose conditions in granting any such 

request. A country designation granted 

by FDA under this paragraph will be 

subject to future review by FDA, and 

may be revoked if FDA determines 

that it is no longer appropriate. 

[70 FR 53068, Sept. 7, 2005, as amended at 71 

FR 59668, Oct. 11, 2006; 73 FR 20794, Apr. 17, 

2008] 

§ 700.35 Cosmetics containing sunscreen ingredients. 

(a) A product that includes the term 

‘‘sunscreen’’ in its labeling or in any 

other way represents or suggests that 

it is intended to prevent, cure, treat, or 

mitigate disease or to affect a structure or function of the body comes 


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Pt. 701 21 CFR Ch. I (4–1–15 Edition) 

within the definition of a drug in section 201(g)(1) of the act. Sunscreen active ingredients affect the structure or 

function of the body by absorbing, reflecting, or scattering the harmful, 

burning rays of the sun, thereby altering the normal physiological response 

to solar radiation. These ingredients 

also help to prevent diseases such as 

sunburn and may reduce the chance of 

premature skin aging, skin cancer, and 

other harmful effects due to the sun 

when used in conjunction with limiting 

sun exposure and wearing protective 

clothing. When consumers see the term 

‘‘sunscreen’’ or similar sun protection 

terminology in the labeling of a product, they expect the product to protect 

them in some way from the harmful effects of the sun, irrespective of other 

labeling statements. Consequently, the 

use of the term ‘‘sunscreen’’ or similar 

sun protection terminology in a product’s labeling generally causes the 

product to be subject to regulation as a 

drug. However, sunscreen ingredients 

may also be used in some products for 

nontherapeutic, nonphysiologic uses 

(e.g., as a color additive or to protect 

the color of the product). To avoid consumer misunderstanding, if a cosmetic 

product contains a sunscreen ingredient and uses the term ‘‘sunscreen’’ or 

similar sun protection terminology 

anywhere in its labeling, the term 

must be qualified by describing the 

cosmetic benefit provided by the sunscreen ingredient. 

(b) The qualifying information required under paragraph (a) of this section shall appear prominently and conspicuously at least once in the labeling 

in conjunction with the term ‘‘sunscreen’’ or other similar sun protection 

terminology used in the labeling. For 

example: ‘‘Contains a sunscreen—to 

protect product color.’’ 

[64 FR 27693, May 21, 1999] 

PART 701—COSMETIC LABELING 

Subpart A—General Provisions 

Sec. 

701.1 Misbranding. 

701.2 Form of stating labeling requirements. 

701.3 Designation of ingredients. 

701.9 Exemptions from labeling requirements. 

Subpart B—Package Form 

701.10 Principal display panel. 

701.11 Identity labeling. 

701.12 Name and place of business of manufacturer, packer, or distributor. 

701.13 Declaration of net quantity of contents. 

Subpart C—Labeling of Specific 

Ingredients 

701.20 Detergent substances, other than 

soap, intended for use in cleansing the 

body. 

701.30 Ingredient names established for cosmetic ingredient labeling. 

AUTHORITY: 21 U.S.C. 321, 352, 361, 362, 363, 

371, 374; 15 U.S.C. 1454, 1455. 

SOURCE: 39 FR 10056, Mar. 15, 1974, unless 

otherwise noted. 

Subpart A—General Provisions 

§ 701.1 Misbranding. 

(a) Among representations in labeling of a cosmetic which render such 

cosmetic misbranded is a false or misleading representation with respect to 

another cosmetic or a food, drug, or device. 

(b) The labeling of a cosmetic which 

contains two or more ingredients may 

be misleading by reason (among other 

reasons) of the designation of such cosmetic in such labeling by a name which 

includes or suggests the name of one or 

more but not all such ingredients, even 

though the names of all such ingredients are stated elsewhere in the labeling. 

§ 701.2 Form of stating labeling requirements. 

(a) A word, statement, or other information required by or under authority 

of the Act to appear on the label may 

lack that prominence and conspicuousness required by section 602(c) of the 

Act by reason (among other reasons) 

of: 

(1) The failure of such word, statement, or information to appear on the 

part or panel of the label which is presented or displayed under customary 

conditions of purchase; 

(2) The failure of such word, statement, or information to appear on two 

or more parts or panels of the label, 

each of which has sufficient space 


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Food and Drug Administration, HHS § 701.3 

therefor, and each of which is so designed as to render it likely to be, 

under customary conditions of purchase, the part or panel displayed; 

(3) The failure of the label to extend 

over the area of the container or package available for such extension, so as 

to provide sufficient label space for the 

prominent placing of such word, statement, or information; 

(4) Insufficiency of label space (for 

the prominent placing of such word, 

statement, or information) resulting 

from the use of label space for any 

word, statement, design, or device 

which is not required by or under authority of the Act to appear on the 

label; 

(5) Insufficiency of label space (for 

the prominent placing of such word, 

statement, or information) resulting 

from the use of label space to give materially greater conspicuousness to any 

other word, statement, or information, 

or to any design or device; 

(6) Smallness or style of type in 

which such word, statement, or information appears, insufficient background contrast, obscuring designs or 

vignettes, or crowding with other written, printed, or graphic matter. 

(b)(1) All words, statements, and 

other information required by or under 

authority of the Act to appear on the 

label or labeling shall appear thereon 

in the English language: Provided, however, That in the case of articles distributed solely in the Commonwealth 

of Puerto Rico or in a Territory where 

the predominant language is one other 

than English, the predominant language may be substituted for English. 

(2) If the label contains any representation in a foreign language, all words, 

statements, and other information required by or under authority of the Act 

to appear on the label shall appear 

thereon in the foreign language. 

(3) If the labeling contains any representation in a foreign language, all 

words, statements, and other information required by or under authority of 

the Act to appear on the label or labeling shall appear on the labeling in the 

foreign language. 

§ 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 §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 §701.30 as 

established by the Commissioner for 

that ingredient for the purpose of cosmetic ingredient labeling pursuant to 

paragraph (e) of this section; 

(2) In the absence of the name specified in §701.30, the name adopted for 

that ingredient in the following editions and supplements of the following 


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§ 701.3 21 CFR Ch. I (4–1–15 Edition) 

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 at the National Archives and Records Administration 

(NARA), which is incorporated by reference, except for the following deletions and revisions. (For information 

on the availability of this material at 

NARA, call 202–741–6030, or go to: http:// 

www.archives.gov/federallregister/ 

codeloflfederallregulations/ 

ibrllocations.html.) 

(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 at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, or 

go to: http://www.archives.gov/ 

federallregister/ 

codeloflfederallregulations/ 

ibrllocations.html.). 

(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 at 

the National Archives and Records Administration (NARA). For information 

on the availability of this material at 

NARA, call 202–741–6030, or go to: http:// 

www.archives.gov/federallregister/ 

codeloflfederallregulations/ 

ibrllocations.html.). 

(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, 5100 Paint Branch 

Pkwy., College Park, MD 20740, or at 


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Food and Drug Administration, HHS § 701.3 

the National Archives and Records Administration (NARA). For information 

on the availability of this material at 

NARA, call 202–741–6030, or go to: http:// 

www.archives.gov/federallregister/ 

codeloflfederallregulations/ 

ibrllocations.html. 

(v) USAN and the USP dictionary of 

drug names, USAN 1975, 1961–1975 cumulative list. (Copies are available 

from the U.S. Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway, 

Rockville, MD 20852, or at the National 

Archives and Records Administration 

(NARA). For information on the availability of this material at NARA, call 

202–741–6030, or go to: http:// 

www.archives.gov/federallregister/ 

codeloflfederallregulations/ 

ibrllocations.html.) 

(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 

an over-the-counter drug product, the 

declaration shall declare the active 

drug ingredients as set forth in 

§201.66(c)(2) and (d) of this chapter, and 

the declaration shall declare the cosmetic ingredients as set forth in 

§201.66(c)(8) and (d) of this chapter. 

(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 §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 


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§ 701.3 21 CFR Ch. I (4–1–15 Edition) 

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 §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 

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, 


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Food and Drug Administration, HHS § 701.3 

in a container that does not contain 

other cosmetic products. 

(6) The firm whose name appears on a 

product pursuant to §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 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 


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§ 701.3 21 CFR Ch. I (4–1–15 Edition) 

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 

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: 


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Food and Drug Administration, HHS § 701.10 

(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 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; 64 FR 13297, 

Mar. 17, 1999; 69 FR 18803, Apr. 9, 2004] 

§ 701.9 Exemptions from labeling requirements. 

(a) Except as provided by paragraphs 

(b) and (c) of this section, a shipment 

or other delivery of a cosmetic which 

is, in accordance with the practice of 

the trade, to be processed, labeled, or 

repacked in substantial quantity at an 

establishment other than that where 

originally processed or packed, shall be 

exempt, during the time of introduction into and movement in interstate 

commerce and the time of holding in 

such establishment, from compliance 

with the labeling requirements of sections 601(a) and 602(b) of the act if: 

(1) The person who introduced such 

shipment or delivery into interstate 

commerce is the operator of the establishment where such cosmetic is to be 

processed, labeled, or repacked; or 

(2) In case such person is not such operator, such shipment or delivery is 

made to such establishment under a 

written agreement, signed by and containing the post office addresses of 

such person and such operator, and 

containing such specifications for the 

processing, labeling, or repacking, as 

the case may be, of such cosmetic in 

such establishment as will insure, if 

such specifications are followed, that 

such cosmetic will not be adulterated 

or misbranded within the meaning of 

the act upon completion of such processing, labeling, or repacking. Such 

person and such operator shall each 

keep a copy of such agreement until 2 

years after the final shipment or delivery of such cosmetic from such establishment, and shall make such copies 

available for inspection at any reasonable hour to any officer or employee of 

the Department who requests them. 

(b) An exemption of a shipment or 

other delivery of a cosmetic under 

paragraph (a)(1) of this section shall, at 

the beginning of the act of removing 

such shipment or delivery, or any part 

thereof, from such establishment, become void ab initio if the cosmetic 

comprising such shipment, delivery, or 

part is adulterated or misbranded within the meaning of the act when so removed. 

(c) An exemption of a shipment or 

other delivery of a cosmetic under 

paragraph (a)(2) of this section shall 

become void ab initio with respect to 

the person who introduced such shipment or delivery into interstate commerce upon refusal by such person to 

make available for inspection a copy of 

the agreement, as required by such 

clause. 

(d) An exemption of a shipment or 

other delivery of a cosmetic under 

paragraph (a)(2) of this section shall 

expire: 

(1) At the beginning of the act of removing such shipment or delivery, or 

any part thereof, from such establishment if the cosmetic comprising such 

shipment, delivery, or part is adulterated or misbranded within the meaning 

of the act when so removed; or 

(2) Upon refusal by the operator of 

the establishment where such cosmetic 

is to be processed, labeled, or repacked, 

to make available for inspection a copy 

of the agreement, as required by such 

clause. 

Subpart B—Package Form 

§ 701.10 Principal display panel. 

The term principal display panel as it 

applies to cosmetics in package form 

and as used in this part, means the part 

of a label that is most likely to be displayed, presented, shown, or examined 

under customary conditions of display 

for retail sale. The principal display 

panel shall be large enough to accommodate all the mandatory label information required to be placed thereon 


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§ 701.11 21 CFR Ch. I (4–1–15 Edition) 

by this part with clarity and conspicuousness and without obscuring designs, 

vignettes, or crowding. Where packages 

bear alternate principal display panels, 

information required to be placed on 

the principal display panel shall be duplicated on each principal display 

panel. For the purpose of obtaining 

uniform type size in declaring the 

quantity of contents of all packages of 

substantially the same size, the term 

‘‘area of the principal display panel’’ 

means the area of the side or surface 

that bears the principal display panel, 

which area shall be: 

(a) In the case of a rectangular package where one entire side properly can 

be considered to be the principal display panel side, the product of the 

height times the width of that side; 

(b) In the case of a cylindrical or 

nearly cylindrical container, 40 percent 

of the product of the height of the container times the circumference; and 

(c) In the case of any other shape of 

container, 40 percent of the total surface of the container: Provided, however, That where such container presents an obvious ‘‘principal display 

panel’’ such as the top of a triangular 

or circular package, the area shall consist of the entire top surface. 

In determining the area of the principal display panel, exclude tops, bottoms, flanges at the tops and bottoms 

of cans, and shoulders and necks of bottles or jars. In the case of cylindrical 

or nearly cylindrical containers, information required by this part to appear 

on the principal display panel shall appear within that 40 percent of the circumference which is most likely to be 

displayed, presented, shown, or examined under customary conditions of display for retail sale. 

§ 701.11 Identity labeling. 

(a) The principal display panel of a 

cosmetic in package form shall bear as 

one of its principal features a statement of the identity of the commodity. 

(b) Such statement of identity shall 

be in terms of: 

(1) The common or usual name of the 

cosmetic; or 

(2) An appropriately descriptive name 

or, when the nature of the cosmetic is 

obvious, a fanciful name understood by 

the public to identify such cosmetic; or 

(3) An appropriate illustration or vignette representing the intended cosmetic use. 

(c) The statement of identity shall be 

presented in bold type on the principal 

display panel, shall be in a size reasonably related to the most prominent 

printed matter on such panel, and shall 

be in lines generally parallel to the 

base on which the package rests as it is 

designed to be displayed. 

§ 701.12 Name and place of business of 

manufacturer, packer, or distributor. 

(a) The label of a cosmetic in package form shall specify conspicuously 

the name and place of business of the 

manufacturer, packer, or distributor. 

(b) The requirement for declaration 

of the name of the manufacturer, packer, or distributor shall be deemed to be 

satisfied in the case of a corporation 

only by the actual corporate name, 

which may be preceded or followed by 

the name of the particular division of 

the corporation. Abbreviations for 

‘‘Company,’’ ‘‘Incorporated,’’ etc., may 

be used and ‘‘The’’ may be omitted. In 

the case of an individual, partnership, 

or association, the name under which 

the business is conducted shall be used. 

(c) Where the cosmetic is not manufactured by the person whose name appears on the label, the name shall be 

qualified by a phrase that reveals the 

connection such person has with such 

cosmetic; such as, ‘‘Manufactured for 

lllllll’’, ‘‘Distributed by 

llllllll’’, or any other wording 

that expresses the facts. 

(d) The statement of the place of 

business shall include the street address, city, State, and ZIP Code; however, the street address may be omitted 

if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP 

Code shall apply only to consumer 

commodity labels developed or revised 

after the effective date of this section. 

In the case of nonconsumer packages, 

the ZIP Code shall appear either on the 

label or the labeling (including the invoice). 

(e) If a person manufactures, packs, 

or distributes a cosmetic at a place 

other than his principal place of business, the label may state the principal 


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Food and Drug Administration, HHS § 701.13 

place of business in lieu of the actual 

place where such cosmetic was manufactured or packed or is to be distributed, unless such statement would be 

misleading. 

§ 701.13 Declaration of net quantity of 

contents. 

(a) The label of a cosmetic in package form shall bear a declaration of the 

net quantity of contents. This shall be 

expressed in terms of weight, measure, 

numerical count, or a combination of 

numerical count and weight or measure. The statement shall be in terms of 

fluid measure if the cosmetic is liquid 

or in terms of weight if the cosmetic is 

solid, semisolid, or viscous, or a mixture of solid and liquid. If there is a 

firmly established, general consumer 

usage and trade custom of declaring 

the net quantity of a cosmetic by numerical count, linear measure, or 

measure of area, such respective term 

may be used. If there is a firmly established, general consumer usage and 

trade custom of declaring the contents 

of a liquid cosmetic by weight, or a 

solid, semisolid, or viscous cosmetic by 

fluid measure, it may be used. Whenever the Commissioner determines for 

a specific packaged cosmetic that an 

existing practice of declaring net quantity of contents by weight, measure, 

numerical count, or a combination of 

these does not facilitate value comparisons by consumers, he shall by regulation designate the appropriate term 

or terms to be used for such cosmetic. 

(b) Statements of weight shall be in 

terms of avoirdupois pound and ounce. 

Statements of fluid measure shall be in 

terms of the U.S. gallon of 231 cubic 

inches and quart, pint, and fluid-ounce 

subdivisions thereof and shall express 

the volume at 68 °F. (20 °C.). 

(c) When the declaration of quantity 

of contents by numerical count, linear 

measure, or measure of area does not 

give accurate information as to the 

quantity of cosmetic in the package, it 

shall be augmented by such statement 

of weight, measure, or size of the individual units or the total weight or 

measure of the cosmetic as will give 

such information. 

(d) The declaration may contain 

common or decimal fractions. A common fraction shall be in terms of 

halves, quarters, eighths, sixteenths, or 

thirty-seconds; except that if there exists a firmly established, general consumer usage and trade custom of employing different common fractions in 

the net quantity declaration of a particular commodity they may be employed. A common fraction shall be reduced to its lowest terms; a decimal 

fraction shall not be carried out to 

more than two places. A statement 

that includes small fractions of an 

ounce shall be deemed to permit smaller variations than one which does not 

include such fractions. 

(e) The declaration shall be located 

on the principal display panel of the 

label; with respect to packages bearing 

alternate principal display panels, it 

shall be duplicated on each principal 

display panel: Provided, That: 

(1) The principal display panel of a 

cosmetic marketed in a ‘‘boudoir-type’’ 

container including decorative cosmetic containers of the ‘‘cartridge,’’ 

‘‘pill box,’’ ‘‘compact,’’ or ‘‘pencil’’ variety, and those with a capacity of onefourth ounce or less, may be considered 

to be a tear-away tag or tape affixed to 

the decorative container and bearing 

the mandatory label information as required by this part, but the type size of 

the net quantity of contents statement 

shall be governed by the dimensions of 

the decorative container; and 

(2) The principal display panel of a 

cosmetic marketed on a display card to 

which the immediate container is affixed may be considered to be the display panel of the card, and the type 

size of the net quantity of content 

statement is governed by the dimensions of the display card. 

(f) The declaration shall appear as a 

distinct item on the principal display 

panel, shall be separated (by at least a 

space equal to the height of the lettering used in the declaration) from 

other printed label information appearing above or below the declaration and 

(by at least a space equal to twice the 

width of the letter ‘‘N’’ of the style of 

type used in the quantity of contents 

statement) from other printed label information appearing to the left or right 

of the declaration. It shall not include 

any term qualifying a unit of weight, 

measure, or count (such as ‘‘giant 

pint’’ and ‘‘full quart’’) that tends to 


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§ 701.13 21 CFR Ch. I (4–1–15 Edition) 

exaggerate the amount of the cosmetic 

in the container. It shall be placed on 

the principal display panel within the 

bottom 30 percent of the area of the 

label panel in line generally parallel to 

the base on which the package rests as 

it is designed to be displayed: Provided, 

That: 

(1) On packages having a principal 

display panel of 5 square inches or less, 

the requirement for placement within 

the bottom 30 percent of the area of the 

label panel shall not apply when the 

declaration of net quantity of contents 

meets the other requirements of this 

part; and 

(2) In the case of a cosmetic that is 

marketed with both outer and inner retail containers bearing the mandatory 

label information required by this part, 

and the inner container is not intended 

to be sold separately, the net quantity 

of contents placement requirement of 

this section applicable to such inner 

containers is waived. 

(g) The declaration shall accurately 

reveal the quantity of cosmetic in the 

package exclusive of wrappers and 

other material packed therewith: Provided, That: 

(1) In the case of cosmetics packed in 

containers designed to deliver the cosmetic under pressure, the declaration 

shall state the net quantity of the contents that will be expelled when the instructions for use as shown on the container are followed. The propellant is 

included in the net quantity declaration; and 

(2) In the case of a package which 

contains the integral components making up a complete kit, and which is designed to deliver the components in the 

manner of an application (for example, 

a home permanent wave kit), the declaration may state the net quantity of 

the contents in nondeceptive terms of 

the number of applications available in 

the kit when the instructions for use as 

shown on the container are followed. 

(h) The declaration shall appear in 

conspicuous and easily legible boldface 

print or type in distinct contrast (by 

typography, layout, color, embossing, 

or molding) to other matter on the 

package; except that a declaration of 

net quantity blown, embossed, or molded on a glass or plastic surface is permissible when all label information is 

so formed on the surface. Requirements 

of conspicuousness and legibility shall 

include the specifications that: 

(1) The ratio of height to width (of 

the letter) shall not exceed a differential of 3 units to 1 unit (no more than 

3 times as high as it is wide). 

(2) Letter heights pertain to upper 

case or capital letters. When upper and 

lower case or all lower case letters are 

used, it is the lower case letter ‘‘o’’ or 

its equivalent that shall meet the minimum standards. 

(3) When fractions are used, each 

component numeral shall meet onehalf the minimum height standards. 

(i) The declaration shall be in letters 

and numerals in a type size established 

in relationship to the area of the principal display panel of the package and 

shall be uniform for all packages of 

substantially the same size by complying with the following type specifications: 

(1) Not less than one-sixteenth inch 

in height on packages the principal display panel of which has an area of 5 

square inches or less. 

(2) Not less than one-eighth inch in 

height on packages the principal display panel of which has an area of more 

than 5 but not more than 25 square 

inches. 

(3) Not less than three-sixteenths 

inch in height on packages the principal display panel of which has an 

area of more than 25 but not more than 

100 square inches. 

(4) Not less than one-fourth inch in 

height on packages the principal display panel of which has an area of more 

than 100 square inches, except not less 

than one-half inch in height if the area 

is more than 400 square inches. 

Where the declaration is blown, embossed, or molded on a glass or plastic 

surface rather than by printing, typing, or coloring, the lettering sizes 

specified in paragraphs (i)(1) through 

(4) of this section shall be increased by 

one-sixteenth of an inch. 

(j) On packages containing less than 

4 pounds or 1 gallon and labeled in 

terms of weight or fluid measure: 

(1) The declaration shall be expressed 

both in ounces, with identification by 

weight or by liquid measure and, if applicable (1 pound or 1 pint or more), followed in parentheses by a declaration 


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Food and Drug Administration, HHS § 701.13 

in pounds for weight units, with any remainder in terms of ounces or common 

or decimal fractions of the pound (as 

set forth in paragraphs (m)(1) and (2) of 

this section), or in the case of liquid 

measure, in the largest whole units 

(quarts, quarts and pints, or pints, as 

appropriate) with any remainder in 

terms of fluid ounces or common or 

decimal fractions of the pint or quart 

(as set forth in paragraphs (m)(3) and 

(4) of this section). Net weight or fluid 

measure of less than 1 ounce shall be 

expressed in common or decimal fractions of the respective ounce and not in 

drams. 

(2) The declaration may appear in 

more than one line. The term ‘‘net 

weight’’ shall be used when stating the 

net quantity of contents in terms of 

weight. Use of the terms ‘‘net’’ or ‘‘net 

contents’’ in terms of fluid measure or 

numerical count is optional. It is sufficient to distinguish avoirdupois ounce 

from fluid ounce through association of 

terms; for example, ‘‘Net wt. 6 oz.’’ or 

‘‘6 oz. net wt.’’ and ‘‘Net contents 6 fl. 

oz.’’ or ‘‘6 fl. oz.’’ 

(k) On packages containing 4 pounds 

or 1 gallon or more and labeled in 

terms of weight or fluid measure, the 

declaration shall be expressed in 

pounds for weight units with any remainder in terms of ounces or common 

or decimal fractions of the pound; in 

the case of fluid measure, it shall be 

expressed in the largest whole unit 

(gallons, followed by common or decimal fractions of a gallon or by the 

next smaller whole unit or units 

(quarts or quarts and pints)) with any 

remainder in terms of fluid ounces or 

common or decimal fractions of the 

pint or quart (as set forth in paragraph 

(m)(5) of this section). 

(l) [Reserved] 

(m) Examples: (1) A declaration of 11⁄2

pounds weight shall be expressed as 

‘‘Net wt. 24 oz. (1 lb. 8 oz.)’’, ‘‘Net wt. 24 

oz. (11⁄2 lb.)’’, or ‘‘Net wt. 24 oz. (1.5 

lb.)’’. 

(2) A declaration of three-fourths 

pound avoirdupois weight shall be expressed as ‘‘Net wt. 12 oz.’’ 

(3) A declaration of 1 quart liquid 

measure shall be expressed as ‘‘Net 

contents 32 fl. oz. (1 qt.)’’. 

(4) A declaration of 13⁄4 quarts liquid 

measure shall be expressed as ‘‘Net 

contents 56 fl. oz. (1 qt. 11⁄2 pt.)’’ or 

‘‘Net contents 56 fl. oz. (1 qt. 1 pt. 8 

oz.)’’ but not in terms of quart and 

ounce such as ‘‘Net content 56 fl. oz. (1 

qt. 24 oz.)’’. 

(5) A declaration of 21⁄2 gallons liquid 

measure shall be expressed in the alternative as ‘‘Net contents 2 gal. 2 qt.’’ 

and not as ‘‘2 gal. 4 pt.’’ 

(n) For quantities, the following abbreviations and none other may be employed (periods and plural forms are 

optional): 

weight wt. 

square sq. 

fluid fl. 

yard yd. 

feet or foot ft. 

inch in. 

gallon gal. 

quart qt. 

pint pt. 

ounce oz. 

pound lb. 

(o) On packages labeled in terms of 

linear measure, the declaration shall 

be expressed both in terms of inches 

and, if applicable (1 foot or more), the 

largest whole units (yards, yards and 

feet, feet). The declaration in terms of 

the largest whole units shall be in parentheses following the declaration in 

terms of inches and any remainder 

shall be in terms of inches or common 

or decimal fractions of the foot or 

yard. Examples are ‘‘86 inches (2 yd. 1 

ft. 2 inches)’’, ‘‘90 inches (21⁄2 yd.)’’, ‘‘30 

inches (2.5 ft.)’’, etc. 

(p) On packages labeled in terms of 

area measure, the declaration shall be 

expressed in terms of square inches 

and, if applicable (1 square foot or 

more), the largest whole square unit 

(square yards, square yards and square 

feet, square feet). The declaration in 

terms of the largest whole units shall 

be in parentheses following the declaration in terms of square inches and 

any remainder shall be in terms of 

square inches or common or decimal 

fractions of the square foot or square 

yard; for example, ‘‘158 sq. inches (1 sq. 

ft. 14 sq. inches)’’, etc. 

(q) Nothing in this section shall prohibit supplemental statements at locations other than the principal display 

panel(s) describing in nondeceptive 

terms the net quantity of contents, 

provided that such supplemental statements of net quantity of contents shall 

not include any term qualifying a unit 

of weight, measure, or count that tends 


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§ 701.20 21 CFR Ch. I (4–1–15 Edition) 

to exaggerate the amount of the cosmetic contained in the package; for example, ‘‘giant pint’’ and ‘‘full quart.’’ 

Dual or combination declarations of 

net quantity of contents as provided 

for in paragraphs (a), (c), and (j) of this 

section (for example, a combination of 

net weight plus numerical count) are 

not regarded as supplemental net quantity statements and shall be located on 

the principal display panel. 

(r) A separate statement of the net 

quantity of contents in terms of the 

metric system is not regarded as a supplemental statement and an accurate 

statement of the net quantity of contents in terms of the metric system of 

weight or measure may also appear on 

the principal display panel or on other 

panels. 

(s) The declaration of net quantity of 

contents shall express an accurate 

statement of the quantity of contents 

of the package. Reasonable variations 

caused by loss or gain of moisture during the course of good distribution 

practice or by unavoidable deviations 

in good manufacturing practice will be 

recognized. Variations from stated 

quantity of contents shall not be unreasonably large. 

Subpart C—Labeling of Specific 

Ingredients 

§ 701.20 Detergent substances, other 

than soap, intended for use in 

cleansing the body. 

(a) In its definition of the term cosmetic, the Federal Food, Drug, and Cosmetic Act specifically excludes soap. 

The term soap is nowhere defined in 

the act. In administering the act, the 

Food and Drug Administration interprets the term ‘‘soap’’ to apply only to 

articles that meet the following conditions: 

(1) The bulk of the nonvolatile matter in the product consists of an alkali 

salt of fatty acids and the detergent 

properties of the article are due to the 

alkali-fatty acid compounds; and 

(2) The product is labeled, sold, and 

represented only as soap. 

(b) Products intended for cleansing 

the human body and which are not 

‘‘soap’’ as set out in paragraph (a) of 

this section are ‘‘cosmetics,’’ and accordingly they are subject to the requirements of the act and the regulations thereunder. For example, such a 

product in bar form is subject to the 

requirement, among others, that it 

shall bear a label containing an accurate statement of the weight of the bar 

in avoirdupois pounds and ounces, this 

statement to be prominently and conspicuously displayed so as to be likely 

to be read under the customary conditions of purchase and use. 

§ 701.30 Ingredient names established 

for cosmetic ingredient labeling. 

The Commissioner establishes the 

following names for the purpose of cosmetic ingredient labeling pursuant to 

paragraph (e) of §701.3: 

Chemical name or description Chemical formula Established label name 

Trichlorofluoromethane .............................................................. CCl3F .................. Chlorofluorocarbon 11. 

Trichlorofluoromethane and 0.3 pct nitromethane .................... CCl3F+CH3NO2 .. Chlorofluorocarbon 11 S. 

Dichlorodifluoromethane ............................................................ CCl2F2 ................ Chlorofluorocarbon 12. 

Chlorodifluoromethane ............................................................... CHClF2 ............... Hydrochlorofluorocarbon 22. 

1, 2-dichloro-1, 1, 2, 2-tetrafluoroethane ................................... CClF2CClF2 ........ Chlorofluorocarbon 114. 

1-Chloro-1, 1-difluoroethane ...................................................... CH3CClF2 ........... Hydrochlorofluorocarbon 142 B. 

1, 1-difluoroethane ..................................................................... CH3CHF2 ............ Hydrofluorocarbon 152 A. 

Ethyl ester of hydrolyzed animal protein is the ester of ethyl 

alcohol and the hydrolysate of collagen or other animal protein, derived by acid, enzyme, or other form of hydrolysis.

............................. Ethyl ester of hydrolyzed animal protein. 

[42 FR 24255, May 13, 1977, as amended at 45 FR 3577, Jan. 18, 1980] 


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Food and Drug Administration, HHS § 710.7 

PART 710—VOLUNTARY REGISTRATION OF COSMETIC PRODUCT 

ESTABLISHMENTS 

Sec. 

710.1 Who should register. 

710.2 Time for registration. 

710.3 How and where to register. 

710.4 Information requested. 

710.5 Amendments to registration. 

710.6 Notification of registrant; cosmetic 

product establishment registration number. 

710.7 Inspection of registrations. 

710.8 Misbranding by reference to registration or to registration number. 

710.9 Exemptions. 

AUTHORITY: 21 U.S.C. 321, 331, 361, 362, 371, 

374. 

SOURCE: 39 FR 10059, Mar. 15, 1974, unless 

otherwise noted. 

§ 710.1 Who should register. 

The owner or operator of a cosmetic 

product establishment which is not exempt under §710.9 and engages in the 

manufacture or packaging of a cosmetic product is requested to register 

for each such establishment, whether 

or not the product enters interstate 

commerce. This request extends to any 

foreign cosmetic product establishment whose products are exported for 

sale in any State as defined in section 

201(a)(1) of the act. No registration fee 

is required. 

§ 710.2 Time for registration. 

The owner or operator of an establishment entering into the manufacture or packaging of a cosmetic product should register his establishment 

within 30 days after the operation begins. 

§ 710.3 How and where to register. 

Form FD–2511 (‘‘Registration of Cosmetic Product Establishment’’) is obtainable on request from the Food and 

Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

or at any Food and Drug Administration district office. The completed 

form should be mailed to Cosmetic 

Product Establishment Registration, 

Food and Drug Administration, 5100 

Paint Branch Pkwy., College Park, MD 

20740. 

[39 FR 10059, Mar. 15, 1974, as amended at 68 

FR 15355, Mar. 31, 2003] 

§ 710.4 Information requested. 

Form FD–2511 requests information 

on the name and address of the cosmetic product establishment, including 

post office ZIP code; all business trading names used by the establishment; 

and the type of business (manufacturer 

and/or packer). The information requested should be given separately for 

each establishment as defined in 

§700.3(j) of this chapter. 

[39 FR 10059, Mar. 15, 1974, as amended at 46 

FR 38073, July 24, 1981; 54 FR 39640, Sept. 27, 

1989] 

§ 710.5 Amendments to registration. 

Within 30 days after a change in any 

of the information contained on a submitted Form FD–2511, a new Form FD– 

2511 should be submitted to amend the 

registration. This amendment is also 

necessary when a registration is to be 

canceled because an establishment has 

changed its name and no longer conducts business under the original 

name. 

§ 710.6 Notification of registrant; cosmetic product establishment registration number. 

The Commissioner of Food and Drugs 

will provide the registrant with a validated copy of Form FD–2511 as evidence of registration. This validated 

copy will be sent only to the location 

shown for the registering establishment. A permanent registration number will be assigned to each cosmetic 

product establishment registered in accordance with the regulations in this 

part. 

§ 710.7 Inspection of registrations. 

A copy of the Form FD–2511 filed by 

the registrant will be available for inspection at the Food and Drug Administration, 5100 Paint Branch Pkwy., 

College Park, MD 20740. 

[39 FR 10059, Mar. 15, 1974, as amended at 68 

FR 15355, Mar. 31, 2003] 


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§ 710.8 21 CFR Ch. I (4–1–15 Edition) 

§ 710.8 Misbranding by reference to 

registration or to registration number. 

Registration of a cosmetic product 

establishment or assignment of a registration number does not in any way 

denote approval of the firm or its products by the Food and Drug Administration. Any representation in labeling or 

advertising that creates an impression 

of official approval because of registration or possession of a registration 

number will be considered misleading. 

§ 710.9 Exemptions. 

The following classes of persons are 

not requested to register in accordance 

with this part 710 because the Commissioner has found that such registration 

is not justified: 

(a) Beauty shops, cosmetologists, retailers, pharmacies, and other persons 

and organizations that compound cosmetic products at a single location and 

administer, dispense, or distribute 

them at retail from that location and 

who do not otherwise manufacture or 

package cosmetic products at that location. 

(b) Physicians, hospitals, clinics, and 

public health agencies. 

(c) Persons who manufacture, prepare, compound, or process cosmetic 

products solely for use in research, 

pilot plant production, teaching, or 

chemical analysis, and who do not sell 

these products. 

PART 720—VOLUNTARY FILING OF 

COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS 

Sec. 

720.1 Who should file. 

720.2 Times for filing. 

720.3 How and where to file. 

720.4 Information requested about cosmetic 

products. 

720.5 [Reserved] 

720.6 Amendments to statement. 

720.7 Notification of person submitting cosmetic product ingredient statement. 

720.8 Confidentiality of statements. 

720.9 Misbranding by reference to filing or 

to statement number. 

AUTHORITY: 21 U.S.C. 321, 331, 361, 362, 371, 

374. 

SOURCE: 39 FR 10060, Mar. 15, 1974, unless 

otherwise noted. 

§ 720.1 Who should file. 

Either the manufacturer, packer, or 

distributor of a cosmetic product is requested to file Form FDA 2512 (‘‘Cosmetic Product Ingredient Statement’’), 

whether or not the cosmetic product 

enters interstate commerce. This request extends to any foreign manufacturer, packer, or distributor of a cosmetic product exported for sale in any 

State as defined in section 201(a)(1) of 

the Federal Food, Drug, and Cosmetic 

Act. No filing fee is required. 

[57 FR 3129, Jan. 28, 1992] 

§ 720.2 Times for filing. 

Within 180 days after forms are made 

available to the industry, Form FDA 

2512 should be filed for each cosmetic 

product being commercially distributed as of the effective date of this 

part. Form FDA 2512 should be filed 

within 60 days after the beginning of 

commercial distribution of any product 

not covered within the 180-day period. 

[57 FR 3129, Jan. 28, 1992] 

§ 720.3 How and where to file. 

Forms FDA 2512 and FDA 2514 (‘‘Discontinuance of Commercial Distribution of Cosmetic Product Formulation’’) are obtainable on request from 

the Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, or at any Food and Drug Administration district office. The completed form should be mailed or delivered to: Cosmetic Product Statement, 

Food and Drug Administration, 5100 

Paint Branch Pkwy., College Park, MD 

20740, according to the instructions 

provided with the forms. 

[57 FR 3129, Jan. 28, 1992, as amended at 68 

FR 15355, Mar. 31, 2003] 

§ 720.4 Information requested about 

cosmetic products. 

(a) Form FDA–2512 requests information on: 

(1) The name and address, including 

post office ZIP code of the person 

(manufacturer, packer, or distributor) 

designated on the label of the product. 


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Food and Drug Administration, HHS § 720.4 

(2) The name and address, including 

post office ZIP code, of the manufacturer or packer of the product if different from the person designated on 

the label of the product, when the manufacturer or packer submits the information requested under this paragraph. 

(3) The brand name or names of the 

cosmetic product. 

(4) The cosmetic product category or 

categories. 

(5) The ingredients in the product. 

(b) The person filing Form FDA–2512 

should: 

(1) Provide the information requested 

in paragraph (a) of this section. 

(2) Have the form signed by an authorized individual. 

(3) Provide poison control centers 

with ingredient information and/or 

adequate diagnostic and therapeutic 

procedures to permit rapid evaluation 

and treatment of accidental ingestion 

or other accidental use of the cosmetic 

product. 

(4) Provide ingredient information 

(and, when requested, ingredient samples) to a licensed physician who, in 

connection with the treatment of a patient, requests assistance in determining whether an ingredient in the 

cosmetic product is the cause of the 

problem for which the patient is being 

treated. 

(c) One or more of the following cosmetic product categories should be 

cited to indicate the product’s intended 

use. 

(1) Baby products. (i) Baby shampoos. 

(ii) Lotions, oils, powders, and 

creams. 

(iii) Other baby products. 

(2) Bath preparations. (i) Bath oils, 

tablets, and salts. 

(ii) Bubble baths. 

(iii) Bath capsules. 

(iv) Other bath preparations. 

(3) Eye makeup preparations. (i) Eyebrow pencil. 

(ii) Eyeliner. 

(iii) Eye shadow. 

(iv) Eye lotion. 

(v) Eye makeup remover. 

(vi) Mascara. 

(vii) Other eye makeup preparations. 

(4) Fragrance preparations. (i) Colognes and toilet waters. 

(ii) Perfumes. 

(iii) Powders (dusting and talcum) 

(excluding aftershave talc). 

(iv) Sachets. 

(v) Other fragrance preparations. 

(5) Hair preparations (noncoloring). (i) 

Hair conditioners. 

(ii) Hair sprays (aerosol fixatives). 

(iii) Hair straighteners. 

(iv) Permanent waves. 

(v) Rinses (noncoloring). 

(vi) Shampoos (noncoloring). 

(vii) Tonics, dressings, and other hair 

grooming aids. 

(viii) Wave sets. 

(ix) Other hair preparations. 

(6) Hair coloring preparations. (i) Hair 

dyes and colors (all types requiring 

caution statement and patch test). 

(ii) Hair tints. 

(iii) Hair rinses (coloring). 

(iv) Hair shampoos (coloring). 

(v) Hair color sprays (aerosol). 

(vi) Hair lighteners with color. 

(vii) Hair bleaches. 

(viii) Other hair coloring preparations. 

(7) Makeup preparations (not eye). (i) 

Blushers (all types). 

(ii) Face powders. 

(iii) Foundations. 

(iv) Leg and body paints. 

(v) Lipstick. 

(vi) Makeup bases. 

(vii) Rouges. 

(viii) Makeup fixatives. 

(ix) Other makeup preparations. 

(8) Manicuring preparations. (i) 

Basecoats and undercoats. 

(ii) Cuticle softeners. 

(iii) Nail creams and lotions. 

(iv) Nail extenders. 

(v) Nail polish and enamel. 

(vi) Nail polish and enamel removers. 

(vii) Other manicuring preparations. 

(9) Oral hygiene products. (i) 

Dentifrices (aerosol, liquid, pastes, and 

powders). 

(ii) Mouthwashes and breath fresheners (liquids and sprays). 

(iii) Other oral hygiene products. 

(10) Personal cleanliness. (i) Bath 

soaps and detergents. 

(ii) Deodorants (underarm). 

(iii) Douches. 

(iv) Feminine hygiene deodorants. 

(v) Other personal cleanliness products. 

(11) Shaving preparations. (i) 

Aftershave lotions. 


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§ 720.5 21 CFR Ch. I (4–1–15 Edition) 

(ii) Beard softeners. 

(iii) Men’s talcum. 

(iv) Preshave lotions (all types). 

(v) Shaving cream (aerosol, 

brushless, and lather). 

(vi) Shaving soap (cakes, sticks, 

etc.). 

(vii) Other shaving preparation products. 

(12) Skin care preparations, (creams, lotions, powder, and sprays). (i) Cleansing 

(cold creams, cleansing lotions, liquids, 

and pads). 

(ii) Depilatories. 

(iii) Face and neck (excluding shaving preparations). 

(iv) Body and hand (excluding shaving preparations). 

(v) Foot powders and sprays. 

(vi) Moisturizing. 

(vii) Night. 

(viii) Paste masks (mud packs). 

(ix) Skin fresheners. 

(x) Other skin care preparations. 

(13) Suntan preparations. (i) Suntan 

gels, creams, and liquids. 

(ii) Indoor tanning preparations. 

(iii) Other suntan preparations. 

(d) Ingredients in the product should 

be listed as follows: 

(1) A list of each ingredient of the 

cosmetic product in descending order 

of predominance by weight (except that 

the fragrance and/or flavor may be designated as such without naming each 

individual ingredient when the manufacturer or supplier of the fragrance 

and/or flavor refuses to disclose ingredient data). 

(2) An ingredient should be listed by 

the name adopted by the Food and 

Drug Administration (FDA) for the ingredient pursuant to §701.3(c) of this 

chapter. 

(3) In the absence of a name adopted 

by FDA pursuant to §701.3(c) of this 

chapter, its common or usual name, if 

it has one, or its chemical or technical 

name should be listed. 

(4) If an ingredient is a mixture, each 

ingredient of the mixture should be 

listed in accordance with paragraphs 

(d)(2) and (d)(3) of this section, unless 

such mixture is a formulation voluntarily registered on Form FDA 2512, in 

which case such mixture should be 

identified as ‘‘fragrance,’’ ‘‘flavor,’’ 

‘‘fragrance and flavor’’ or ‘‘base formulation,’’ as appropriate, and by stating 

its FDA-assigned cosmetic product ingredient statement number. 

(5) When the manufacturer or supplier of a fragrance and/or flavor refuses to disclose ingredient data, the 

fragrance and/or flavor should be listed 

as such. The nonconfidential listing of 

the product name and/or trade name or 

name of the manufacturer or supplier 

of each proprietary fragrance and/or 

flavor mixture is optional. 

(e) A separate Form FDA–2512 should 

be filed for each different formulation 

of a cosmetic product. However, except 

for the hair coloring preparations listed in paragraph (c)(6) of this section for 

which a statement for each shade of 

such product is required, a single Form 

FDA–2512 may be filed for two or more 

shades of a cosmetic product where 

only the amounts of the color additive 

ingredient used are varied or in the 

case of flavors and fragrances where 

only the amounts of the flavors and 

fragrances used are varied. 

(Information collection requirements in this 

section were approved by the Office of Management and Budget (OMB) and assigned 

OMB control number 0910–0030) 

[39 FR 10060, Mar. 15, 1974, as amended at 46 

FR 38073, July 24, 1981; 57 FR 3129, Jan. 28, 

1992] 

§ 720.5 [Reserved] 

§ 720.6 Amendments to statement. 

Changes in the information requested 

under §§720.4 (a)(3) and (a)(5) on the ingredients or brand name of a cosmetic 

product should be submitted by filing 

an amended Form FDA 2512 within 60 

days after the product is entered into 

commercial distribution. Other 

changes do not justify immediate 

amendment, but should be shown by 

filing an amended Form FDA 2512 within a year after such changes. Notice of 

discontinuance of commercial distribution of a cosmetic product formulation 

should be submitted by Form FDA 2514 

within 180 days after discontinuance of 

commercial distribution becomes 

known to the person filing. 

[57 FR 3130, Jan. 28, 1992, as amended at 67 

FR 9587, Mar. 4, 2002] 


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Food and Drug Administration, HHS § 720.8 

§ 720.7 Notification of person submitting cosmetic product ingredient 

statement. 

When Form FDA 2512 is received, 

FDA will either assign a permanent 

cosmetic product ingredient statement 

number or a Food and Drug Administration (FDA) reference number in 

those cases where a permanent number 

cannot be assigned. Receipt of the form 

will be acknowledged by sending the 

individual signing the statement an appropriate notice bearing either the 

FDA reference number or the permanent cosmetic product ingredient 

statement number. If the person submitting Form FDA 2512 has not complied with §§720.4 (b)(1) and (b)(2), the 

person will be notified as to the manner in which the statement is incomplete. 

[57 FR 3130, Jan. 28, 1992] 

§ 720.8 Confidentiality of statements. 

(a) Data and information contained 

in, attached to, or included with Forms 

FDA 2512 and FDA 2514, and amendments thereto are submitted voluntarily to the Food and Drug Administration (FDA). Any request for confidentiality of a cosmetic ingredient 

submitted with such forms or separately will be handled in accordance 

with the procedure set forth in this 

section. The request for confidentiality 

will also be subject to the provisions of 

§20.111 of this chapter, as well as to the 

exemptions in subpart D of part 20 of 

this chapter and to the limitations on 

exemption in subpart E of part 20 of 

this chapter. 

(b) Any request for confidentiality of 

the identity of a cosmetic ingredient 

should contain a full statement, in a 

well-organized format, of the factual 

and legal grounds for that request, including all data and other information 

on which the petitioner relies, as well 

as representative information known 

to the petitioner that is unfavorable to 

the petitioner’s position. The statement of the factual grounds should include, but should not be limited to, scientific or technical data, reports, tests, 

and other relevant information addressing the following factors that 

FDA will consider in determining 

whether the identity of an ingredient 

qualifies as a trade secret: 

(1) The extent to which the identity 

of the ingredient is known outside petitioner’s business; 

(2) The extent to which the identity 

of the ingredient is known by employees and others involved in petitioner’s 

business; 

(3) The extent of measures taken by 

the petitioner to guard the secrecy of 

the information; 

(4) The value of the information 

about the identity of the claimed trade 

secret ingredient to the petitioner and 

to its competitors; 

(5) The amount of effort or money expended by petitioner in developing the 

ingredient; and 

(6) The ease or difficulty with which 

the identity of the ingredient could be 

properly acquired or duplicated by others. 

(c) The request for confidentiality 

should also be accompanied by a statement that the identity of the ingredient for which confidentiality is requested has not previously been published or disclosed to anyone other 

than as provided in §20.81(a) of this 

chapter. 

(d) FDA will return to the petitioner 

any request for confidentiality that 

contains insufficient data to permit a 

review of the merits of the request. 

FDA will also advise the petitioner 

about the additional information that 

is necessary to enable the agency to 

proceed with its review of the request. 

(e) If, after receiving all of the data 

that are necessary to make a determination about whether the identity of 

an ingredient is a trade secret, FDA 

tentatively decides to deny the request, the agency will inform the person requesting trade secrecy of its tentative determination in writing. FDA 

will set forth the grounds upon which 

it relied in making this tentative determination. The petitioner may withdraw the records for which FDA has 

tentatively denied a request for confidentiality or may submit, within 60 

days from the date of receipt of the 

written notice of the tentative denial, 

additional relevant information and arguments and request that the agency 

reconsider its decision in light of both 


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§ 720.9 21 CFR Ch. I (4–1–15 Edition) 

the additional material and the information that it originally submitted. 

(f) If the petitioner submits new data 

in response to FDA’s tentative denial 

of trade secret status, the agency will 

consider that material together with 

the information that was submitted 

initially before making its final determination. 

(g) A final determination that an ingredient is not a trade secret within 

the meaning of §20.61 of this chapter 

constitutes final agency action that is 

subject to judicial review under 5 

U.S.C. Chapter 7. If suit is brought 

within 30 calendar days after such a determination, FDA will not disclose the 

records involved or require that the 

disputed ingredient or ingredients be 

disclosed in labeling until the matter 

is finally determined in the courts. If 

suit is not brought within 30 calendar 

days after a final determination that 

an ingredient is not a trade secret 

within the meaning of 21 CFR 20.61, and 

the petitioner does not withdraw the 

records for which a request for confidentiality has been denied, the 

records involved will be made a part of 

FDA files and will be available for public disclosure upon request. 

[51 FR 11444, Apr. 3, 1986, as amended at 57 

FR 3130, Jan. 28, 1992; 68 FR 25288, May 12, 

2003] 

§ 720.9 Misbranding by reference to filing or to statement number. 

The filing of Form FDA 2512 or assignment of a number to the statement 

does not in any way denote approval by 

the Food and Drug Administration of 

the firm or the product. Any representation in labeling or advertising that 

creates an impression of official approval because of such filing or such 

number will be considered misleading. 

[57 FR 3130, Jan. 28, 1992] 

PART 740—COSMETIC PRODUCT 

WARNING STATEMENTS 

Subpart A—General 

Sec. 

740.1 Establishment of warning statements. 

740.2 Conspicuousness of warning statements. 

Subpart B—Warning Statements 

740.10 Labeling of cosmetic products for 

which adequate substantiation of safety 

has not been obtained. 

740.11 Cosmetics in self-pressurized containers. 

740.12 Feminine deodorant sprays. 

740.17 Foaming detergent bath products. 

740.18 Coal tar hair dyes posing a risk of 

cancer. 

740.19 Suntanning preparations. 

AUTHORITY: 21 U.S.C. 321, 331, 352, 355, 361, 

362, 371, 374. 

Subpart A—General 

§ 740.1 Establishment of warning statements. 

(a) The label of a cosmetic product 

shall bear a warning statement whenever necessary or appropriate to prevent a health hazard that may be associated with the product. 

(b) The Commissioner of Food and 

Drugs, either on his own initiative or 

on behalf of any interested person who 

has submitted a petition, may publish 

a proposal to establish or amend, under 

subpart B of this part, a regulation prescribing a warning for a cosmetic. Any 

such petition shall include an adequate 

factual basis to support the petition, 

shall be in the form set forth in part 10 

of this chapter, and will be published 

for comment if it contains reasonable 

grounds for the proposed regulation. 

[40 FR 8917, Mar. 3, 1975, as amended at 42 FR 

15676, Mar. 22, 1977] 

§ 740.2 Conspicuousness of warning 

statements. 

(a) A warning statement shall appear 

on the label prominently and conspicuously as compared to other words, 

statements, designs, or devices and in 

bold type on contrasting background to 

render it likely to be read and understood by the ordinary individual under 

customary conditions of purchase and 

use, but in no case may the letters and/ 

or numbers be less than 1⁄16 inch in 

height, unless an exemption pursuant 

to paragraph (b) of this section is established. 

(b) If the label of any cosmetic package is too small to accommodate the 

information as required by this section, the Commissioner may establish 

by regulation an acceptable alternative 


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Food and Drug Administration, HHS § 740.11 

method, e.g., type size smaller than 1⁄16

inch in height. A petition requesting 

such a regulation, as an amendment to 

this section, shall be submitted to the 

Division of Dockets Management in the 

form established in part 10 of this chapter. 

[40 FR 8917, Mar. 3, 1975, as amended at 42 FR 

15676, Mar. 22, 1977; 69 FR 13717, Mar. 24, 2004] 

Subpart B—Warning Statements 

§ 740.10 Labeling of cosmetic products 

for which adequate substantiation 

of safety has not been obtained. 

(a) Each ingredient used in a cosmetic product and each finished cosmetic product shall be adequately substantiated for safety prior to marketing. Any such ingredient or product 

whose safety is not adequately substantiated prior to marketing is misbranded unless it contains the following conspicuous statement on the 

principal display panel: 

Warning—The safety of this product has 

not been determined. 

(b) An ingredient or product having a 

history of use in or as a cosmetic may 

at any time have its safety brought 

into question by new information that 

in itself is not conclusive. The warning 

required by paragraph (a) of this section is not required for such an ingredient or product if: 

(1) The safety of the ingredient or 

product had been adequately substantiated prior to development of the new 

information; 

(2) The new information does not 

demonstrate a hazard to human health; 

and 

(3) Adequate studies are being conducted to determine expeditiously the 

safety of the ingredient or product. 

(c) Paragraph (b) of this section does 

not constitute an exemption to the 

adulteration provisions of the Act or to 

any other requirement in the Act or 

this chapter. 

[40 FR 8917, Mar. 3, 1975] 

§ 740.11 Cosmetics in self-pressurized 

containers. 

(a)(1) The label of a cosmetic packaged in a self-pressurized container and 

intended to be expelled from the package under pressure shall bear the following warning: 

Warning—Avoid spraying in eyes. Contents 

under pressure. Do not puncture or incinerate. Do not store at temperature above 120 

°F. Keep out of reach of children. 

(2) In the case of products intended 

for use by children, the phrase ‘‘except 

under adult supervision’’ may be added 

at the end of the last sentence in the 

warning required by paragraph (a)(1) of 

this section. 

(3) In the case of products packaged 

in glass containers, the word ‘‘break’’ 

may be substituted for the word 

‘‘puncture’’ in the warning required by 

paragraph (a)(1) of this section. 

(4) The words ‘‘Avoid spraying in 

eyes’’ may be deleted from the warning 

required by paragraph (a)(1) of this section in the case of a product not expelled as a spray. 

(b)(1) In addition to the warning required by paragraph (a)(1) of this section, the label of a cosmetic packaged 

in a self-pressurized container in which 

the propellant consists in whole or in 

part of a halocarbon or a hydrocarbon 

shall bear the following warning: 

Warning—Use only as directed. Intentional 

misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. 

(2) The warning required by paragraph (b)(1) of this section is not required for the following products: 

(i) Products expelled in the form of a 

foam or cream, which contain less than 

10 percent propellant in the container. 

(ii) Products in a container with a 

physical barrier that prevents escape of 

the propellant at the time of use. 

(iii) Products of a net quantity of 

contents of less than 2 ozs. that are designed to release a measured amount of 

product with each valve actuation. 

(iv) Products of a net quantity of 

contents of less than 1⁄2 oz. 

(c) Labeling requirements for cosmetics packaged in a self- pressurized 

container containing or manufactured 

with a chlorofluorocarbon propellant 

or other ozone-depleting substance designated by the Environmental Protection Agency (EPA) are set forth in 40 

CFR part 82. 

[40 FR 8917, Mar. 3, 1975, as amended at 42 FR 

22033, Apr. 29, 1977; 54 FR 39640, Sept. 27, 1989; 

61 FR 20101, May 3, 1996] 


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§ 740.12 21 CFR Ch. I (4–1–15 Edition) 

§ 740.12 Feminine deodorant sprays. 

(a) For the purpose of this section, 

the term ‘‘feminine deodorant spray’’ 

means any spray deodorant product 

whose labeling represents or suggests 

that the product is for use in the female genital area or for use all over 

the body. 

(b) The label of a feminine deodorant 

spray shall bear the following statement: 

Caution—For external use only. Spray at 

least 8 inches from skin. Do not apply to broken, irritated, or itching skin. Persistent, 

unusual odor or discharge may indicate conditions for which a physician should be consulted. Discontinue use immediately if rash, 

irritation, or discomfort develops. 

The sentence ‘‘Spray at least 8 inches 

from skin’’ need not be included in the 

cautionary statement for products 

whose expelled contents do not contain 

a liquified gas propellant such as a 

halocarbon or hydrocarbon propellant. 

(c) Use of the word ‘‘hygiene’’ or 

‘‘hygienic’’ or a similar word or words 

renders any such product misbranded 

under section 602(a) of the Federal 

Food, Drug, and Cosmetic Act. The use 

of any word or words which represent 

or suggest that such products have a 

medical usefulness renders such products misbranded under section 502(a) of 

the Act and illegal new drugs marketed 

in violation of section 505 of the Act. 

[40 FR 8929, Mar. 3, 1975] 

§ 740.17 Foaming detergent bath products. 

(a) For the purpose of this section, a 

foaming detergent bath product is any 

product intended to be added to a bath 

for the purpose of producing foam that 

contains a surface-active agent serving 

as a detergent or foaming ingredient. 

(b) The label of foaming detergent 

bath products within the meaning of 

paragraph (a) of this section, except for 

those products that are labeled as intended for use exclusively by adults, 

shall bear adequate directions for safe 

use and the following caution: 

Caution—Use only as directed. Excessive 

use or prolonged exposure may cause irritation to skin and urinary tract. Discontinue 

use if rash, redness, or itching occurs. Consult your physician if irritation persists. 

Keep out of reach of children. 

(c) In the case of products intended 

for use by children, the phrase ‘‘except 

under adult supervision’’ may be added 

at the end of the last sentence in the 

caution required by paragraph (b) of 

this section. 

[51 FR 20475, June 5, 1986] 

§ 740.18 Coal tar hair dyes posing a 

risk of cancer. 

(a) The principal display panel of the 

label and any labeling accompanying a 

coal tar hair dye containing any ingredient listed in paragraph (b) of this section shall bear, in accordance with the 

requirements of §740.2, the following: 

Warning—Contains an ingredient that can 

penetrate your skin and has been determined 

to cause cancer in laboratory animals. 

(b) Hair dyes containing any of the 

following ingredients shall comply 

with the requirements of this section: 

(1) 4-methoxy-m-phenylenediamine (2,4- 

diaminoanisole) and (2) 4-methoxy-mphenylenediamine sulfate (2,4- 

diaminoanisole sulfate). 

[44 FR 59522, Oct. 16, 1979] 

EFFECTIVE DATE NOTE: At 47 FR 7829, Feb. 

23, 1982, §740.18 was stayed until further notice, effective Sept. 18, 1980. 

§ 740.19 Suntanning preparations. 

The labeling of suntanning preparations that do not contain a sunscreen 

ingredient must display the following 

warning: ‘‘Warning—This product does 

not contain a sunscreen and does not 

protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin 

aging, skin cancer, and other harmful 

effects to the skin even if you do not 

burn.’’ For purposes of this section, the 

term ‘‘suntanning preparations’’ includes gels, creams, liquids, and other 

topical products that are intended to 

provide cosmetic effects on the skin 

while tanning through exposure to UV 

radiation (e.g., moisturizing or conditioning products), or to give the appearance of a tan by imparting color to 

the skin through the application of approved color additives (e.g., 

dihydroxyacetone) without the need for 

exposure to UV radiation. The term 

‘‘suntanning preparations’’ does not include products intended to provide sun 


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Food and Drug Administration, HHS § 740.19 

protection or otherwise intended to affect the structure or any function of 

the body. 

[64 FR 27693, May 21, 1999] 

PARTS 741–799 [RESERVED] 


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