§ M020.10 Sunscreen active ingredients

Law · OTC Monograph M020.10 · posted 24 Sep 2021 · checked 30 Sep 2026 · Official source: accessdata.fda.gov

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 sun protection factor (SPF) value of not less than 2 as measured by the testing procedures established in § M020.80:

(a) Aminobenzoic acid (PABA) up to 15 percent.

(b) Avobenzone up to 3 percent.

(c) Cinoxate up to 3 percent.

(d) Dioxybenzone up to 3 percent.

(e) Ensulizole2 up to 4 percent.

(f) Homosalate up to 15 percent.

(g) Meradimate3 up to 5 percent.

(h) Octinoxate4 up to 7.5 percent.

(i) Octisalate5 up to 5 percent.

(j) Octocrylene up to 10 percent.

(k) Oxybenzone up to 6 percent.

(l) Padimate O up to 8 percent.

(m) Sulisobenzone up to 10 percent.

(n) Titanium dioxide up to 25 percent.

(o) Trolamine salicylate up to 12 percent.

(p) Zinc oxide up to 25 percent.

2 Previously identified as Phenylbenzimidazole sulfonic acid.

3 Previously identified as Menthyl anthranilate.

4 Previously identified as Octyl methoxycinnamate.

5 Previously identified as Octyl salicylate.

page 3