21 CFR 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.
(iii) Eye shadow.
(iv) Eye lotion.
(v) Eye makeup remover.
(vii) Other eye makeup preparations.
(4) Fragrance preparations.
(i) Colognes and toilet waters.
(iii) Powders (dusting and talcum) (excluding aftershave talc).
(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.
(iv) Leg and body paints.
(vi) Makeup bases.
(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).
(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).
(iii) Face and neck (excluding shaving preparations).
(iv) Body and hand (excluding shaving preparations).
(v) Foot powders and sprays.
(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).
(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.