21 C.F.R. § 352.10

Current through November 30, 2024

Section 352.10 - Sunscreen active ingredients

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.

21 C.F.R. §352.10

64 FR 27687, May 21, 1999

Effective Date Note: At 67 FR 41823, June 20, 2002, §352.10 was amended by revising paragraphs (f) through (n), effective Sept. 1, 2002. This amendment could not be incorporated because at 66 FR 67485, Dec. 31, 2001, the effective date was stayed until further notice. For the convenience of the user, the revised text is set forth as follows:

§352.10 Sunscreen active ingredients./h4> hr class="stars">

(f) Ensulizole up to 4 percent.

(g) Homosalate up to 15 percent.

(h) [Reserved]

(i) Meradimate up to 5 percent.

(j) Octinoxate up to 7.5 percent.

(k) Octisalate up to 5 percent.

(l) Octocrylene up to 10 percent.

(m) Oxybenzone up to 6 percent.

(n) Padimate O up to 8 percent.

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