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21CFR352.10

§ 352.10 Sunscreen active ingredients.

Regulation Text

The active ingredient of the product consists of any of the following, within the concentration specified for each ingredient, and the finished product provides a minimum SPF value of not less than 2 as measured by the testing procedures established in subpart D of this part : (a) Aminobenzoic acid (PABA) up to 15 percent. (b) Avobenzone up to 3 percent. (c) Cinoxate up to 3 percent. (d) [Reserved] (e) Dioxybenzone up to 3 percent. (f) Homosalate up to 15 percent. (g) [Reserved] (h) Menthyl anthranilate up to 5 percent. (i) Octocrylene up to 10 percent. (j) Octyl methoxycinnamate up to 7.5 percent. (k) Octyl salicylate up to 5 percent. (l) Oxybenzone up to 6 percent. (m) Padimate O up to 8 percent. (n) Phenylbenzimidazole sulfonic acid up to 4 percent. (o) Sulisobenzone up to 10 percent. (p) Titanium dioxide up to 25 percent. (q) Trolamine salicylate up to 12 percent. (r) Zinc oxide up to 25 percent.

Authority

21 U.S.C. 321,351,352,353,355,360,371.

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21CFR352.10 — § 352.10 Sunscreen active ingredients. | CFR Explorer | BioRegHub