FDA Adds Bemotrizinol to Over-the-Counter Sunscreens

The United States has its first new sunscreen filter in decades. Final administrative order OTC000039 adds bemotrizinolBemotrizinolModerateBis-Ethylhexyloxyphenol Methoxyphenyl Triazine · Organic UV filter (triazine)Broad-spectrum UVA/UVB filter newly GRASE on the U.S. OTC sunscreen monograph at up to 6%.Open in the Index → (BEMT) to OTC Monograph M020 at concentrations up to 6%. The order’s effective date was 9 August 2026, with a typographical correction posted 10 August[1][2].

DSM’s OMOR carried time-limited exclusivity under section 505G. Formulators still have to clear M020 conditions on combinations and dosage forms—oil, lotion, cream, gel, butter, paste, ointment, stick, and specified sprays among them—but the substance itself is now a monograph active[1][2].

Bemotrizinol has been used in Europe and Asia for years; what is new is its lawful status under M020 in the United States.