C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 352—SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] › Subpart B—Active Ingredients

21 C.F.R. § 352.10

Sunscreen active ingredients

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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.

[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.

(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.

Notes of Decisions
Cited in 2 cases (2 in the last 5 years), 2022–2023 · leading case: MEZA v. Coty, Inc. (N.D. Cal. 2023).
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MEZA v. Coty, Inc. (N.D. Cal. 2023). “21 C.F.R. § 352.10 (j). Moreover, the use of sun protection terminology on a 16 product’s label “generally causes the product to be subject to regulation as a drug.”
Truss v. Bayer HealthCare Pharm., Inc. (S.D.N.Y. 2022). “21 C.F.R. § 352.10 (l); (see SAC ¶ 22). Because the Court concludes the FDCA does not mandate disclosure of degradation byproducts (like benzophenone), the labeling duties plaintiffs seek to impose are additional to those imposed by the FDCA.”
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