On June 10, 2026, the U.S. Food and Drug Administration (FDA) issued Final Administrative Order OTC000039 amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use. The order adds bemotrizinol as a permitted sunscreen active ingredient at concentrations up to 6% for use in nonprescription sunscreen drug products. The amendment follows a Tier 1 OTC Monograph Order Request (OMOR) submitted by DSM Nutritional Products LLC on September 23, 2024. Following a scientific review of clinical, nonclinical, pharmacology, and literature data, FDA concluded that bemotrizinol is generally recognized as safe and effective (GRASE) for use in sunscreen products intended for adults and children aged 6 months and older. The Agency determined that sunscreen products containing bemotrizinol may be marketed without an approved New Drug Application (NDA) provided they comply with specified monograph conditions, including a maximum concentration of 6% and a minimum SPF value of 2. The final order permits bemotrizinol to be used alone or in combination with approved sunscreen active ingredients, except aminobenzoic acid (PABA) and trolamine salicylate, which FDA determined should not be combined with bemotrizinol due to safety concerns. The ingredient may also be combined with certain skin protectant active ingredients identified in OTC Monograph M016, subject to applicable formulation and labeling requirements. FDA further established dosage-form restrictions for products containing bemotrizinol. Permitted dosage forms include oil, lotion, cream, gel, butter, paste, ointment, stick, and certain spray products. Spray formulations must either be propellant-free or use systems in which the propellant is isolated from the drug formulation. FDA did not approve aerosol sprays in which the propellant is directly mixed with the sunscreen formulation, nor powder dosage forms, citing insufficient supporting data. The Agency concluded that no additional bemotrizinol-specific labeling requirements are necessary beyond existing OTC sunscreen labeling provisions. FDA also granted DSM Nutritional Products LLC an 18-month marketing exclusivity period under section 505G(b)(5)(C)(i) of the Federal Food, Drug, and Cosmetic Act for products incorporating the approved monograph change.
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