The U.S. Food and Drug Administration issued a final administrative order on June 9, 2026, adding bemotrizinol (BEMT) to the over-the-counter sunscreen monograph — making it the first new active sunscreen ingredient cleared for broad U.S. consumer use in roughly 25 years. The order, designated OTC000039 under Docket FDA-2025-N-6494, takes effect August 9, 2026.
What bemotrizinol is — and why it took so long
Bemotrizinol is a broad-spectrum UV filter that absorbs across both the UVA and UVB ranges. It has been in commercial sunscreens in the European Union since 2000 and is widely used across Asia, where it is marketed by Swiss-Dutch manufacturer DSM-Firmenich under the trade name Parsol Shield. The ingredient is notable for its photostability: studies show that more than 98% of the molecule remains intact even after high-dose UV exposure, a contrast to older chemical filters that can degrade in sunlight and may require pairing with stabilizers.
The previous benchmark for U.S. sunscreen chemistry was set in 1999, when the FDA finalized the OTC sunscreen monograph that included avobenzone as the last new chemical UV filter cleared for widespread use. For more than two decades after that, a backlog of applications for newer European and Asian filters — including several submitted in the mid-2000s — stalled under the legacy rulemaking process, which required formal Federal Register rulemaking that could take many years.
The CARES Act pathway
The Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 overhauled the OTC monograph system, replacing the slow rulemaking track with a faster administrative order process. OTC000039 is the first new active ingredient added to any OTC monograph under that streamlined authority — a proof of concept for a pathway lawmakers designed in part to resolve exactly this kind of multi-decade logjam.
FDA issued a proposed order in December 2025, accepted public comment through January 26, 2026, and finalized the order within roughly six months — a pace that would have been difficult under the prior framework.
What the order authorizes
Under OTC000039, manufacturers may include bemotrizinol at concentrations up to 6% in finished sunscreen drug products. The FDA determined the ingredient is generally recognized as safe and effective (GRASE) for use by adults and children 6 months of age and older — consistent with the labeling standard applied to other OTC sunscreen actives.
In its scientific review, the agency found that bemotrizinol is minimally absorbed through the skin into systemic circulation, a characteristic that distinguished it favorably from some older chemical filters currently under closer scrutiny. Studies submitted to FDA showed no evidence of skin irritation, sensitization, photo-allergenic response, or phototoxicity.
Exclusivity and market timeline
DSM-Firmenich, which filed the original petition, holds an 18-month market exclusivity period under the CARES Act framework, running from the date the first commercial product containing BEMT goes on sale in the United States. The company has signaled that consumer products could reach shelves as early as late summer 2026. After the exclusivity window closes, any sunscreen manufacturer may formulate with bemotrizinol under the monograph conditions.
The FDA’s order does not constitute a new drug approval; rather, it is a GRASE determination under the OTC monograph system, which governs how active ingredients may be used in self-care drug products sold without a prescription.