Inside Bemotrizinol's Public Comment Window: Dec 2025 to Jan 2026
For roughly six weeks, anyone could tell the FDA whether bemotrizinol belonged in US sunscreen - here's how that decision actually worked.
After the FDA issued its proposed order amending OTC Monograph M020, it opened a public comment period running December 12, 2025 to January 26, 2026 under docket OTC000039.
Regulatory analysts note that the comment window is where dermatology groups, manufacturers and ordinary consumers can formally weigh in before the FDA issues a final administrative order.
Questions we get a lot
When was the public comment period for bemotrizinol?
The FDA's proposed order amending OTC Monograph M020 opened a public comment period that ran from December 12, 2025 to January 26, 2026 under docket OTC000039. During that window, dermatology groups, manufacturers and members of the public could submit comments. The agency reviews those comments before issuing a final order.
Does a proposed order mean bemotrizinol is approved?
No. A proposed administrative order is an intermediate step, not a final approval. Legal analysts explain that the FDA must still consider public comments and issue a final order before the change takes full effect. Until then, products cannot be marketed in the US using the new filter.
Who typically comments on a sunscreen monograph order?
Coverage of the process notes that dermatology organizations, sunscreen manufacturers, ingredient suppliers and the general public can all submit input during the comment window. These submissions become part of the official docket. The FDA weighs them before finalizing the order.
r/SkincareAddiction: 'Wait, the FDA proposed bemotrizinol but it's not approved yet? What's this comment period and can regular people actually submit something?'