GroundRules
21 CFR 352.10: Sunscreen active ingredients.
Where this section sits in the code
- Title 21—Food and Drugs
- 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
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON