21 CFR 720.4 - Information requested about cosmetic products.
(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) 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) 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]
Title 21 published on 2013-04-01
no entries appear in the Federal Register after this date.