[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR720.4]

[Page 157-159]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 720_VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION 
 
Sec. 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.
    (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.

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    (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.
    (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 Sec. 
701.3(c) of this chapter.
    (3) In the absence of a name adopted by FDA pursuant to Sec. 
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

[[Page 159]]

(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]