FDA bemotrizinol proposed order moves toward final stage; clean SPF awaits U.S. unlock

Update (May 2026): The FDA's December 12, 2025 proposed administrative order OTC000039 to add bemotrizinol to the U.S. sunscreen monograph at up to 6% closed its public comment period on January 26, 2026. As of mid-May 2026 no final order has been issued — the rule remains in the final-order phase past the FDA's initial March 2026 window. The first new monograph filter in over 20 years (photostable, broad-spectrum UVA+UVB, low absorption) would unlock the first genuinely new formulation tool for U.S. clean-positioned SPF brands in a generation. Supergoop CEO Melis del Rey (appointed December 2025) sits at the front of the sequencing question.

Source

FDA / Federal Register

FDA bemotrizinol proposed order moves toward final stage; clean SPF awaits U.S. unlock

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