US Sunscreen Regulation — FDA OTC Monograph
Approved active ingredients, labeling requirements, SPF testing, and what you can and cannot say on a sunscreen label
Sunscreens Are OTC Drugs, Not Cosmetics
In the United States, sunscreens are regulated by the FDA as over-the-counter (OTC) drugs under the Federal Food, Drug, and Cosmetic Act — not as cosmetics. This single distinction has enormous consequences. It means sunscreen formulas must comply with strict rules about which active ingredients are permitted, at what concentrations, how the product is tested, and exactly what language must appear on the label.
The legal framework is the OTC Drug Monograph system. Rather than requiring each manufacturer to submit a full New Drug Application (NDA) for every sunscreen formula, the FDA publishes a monograph — essentially a public recipe for what is allowed. Any product that follows the monograph exactly can be marketed without individual FDA approval. Products that fall outside it require an NDA.
The Sunscreen Monograph: M020
The current governing rule for OTC sunscreens in the US is codified at 21 CFR Part 352, with significant updates proposed in 2019 and formalized under the CARES Act of 2020. The 2019 Proposed Rule (Federal Register Vol. 84, No. 38) updated GRASE (Generally Recognized As Safe and Effective) classifications and proposed new labeling requirements that are still partially in transition.
Category I — GRASE
Zinc Oxide, Titanium Dioxide
Category II — Not GRASE
PABA, Trolamine Salicylate
Category III — Insufficient Data
12 chemical filters including oxybenzone, avobenzone, octinoxate