Bemotrizinol Explained: The FDA's First New Filter Proposal in 25+ Years
A 'European-grade' broad-spectrum filter is finally in the FDA's pipeline - here's the proposed-order timeline and what it means for US shelves.
On December 11, 2025, the FDA issued a proposed administrative order to add bemotrizinol to OTC sunscreen monograph M020 at concentrations up to 6%, with a public comment period running through January 26, 2026 - the first new active ingredient proposed for US sunscreens since the late 1990s. The FDA found it offers broad-spectrum UVA/UVB protection with low systemic absorption, suitable for adults and children as young as 6 months.
Legal analysts at Holland & Knight characterize the proposed order as the first new sunscreen ingredient the FDA has advanced in decades, while NBC News coverage emphasizes its potential to strengthen UVA protection for US consumers.
Questions we get a lot
When does the public comment period on bemotrizinol close?
The FDA's proposed order opened a public comment period running through January 26, 2026. During that window, stakeholders and the public can submit input before the agency considers finalizing the order. The proposal was issued on December 11, 2025 to amend OTC sunscreen monograph M020.
How well does bemotrizinol protect, and is it absorbed by the body?
The FDA found that bemotrizinol provides broad-spectrum UVA/UVB protection with low systemic absorption, and deemed it suitable for adults and children as young as 6 months. NBC News coverage highlighted its UVA-protection benefits. As a proposed order, these findings are part of the regulatory record rather than a final approval.
Is bemotrizinol already approved, or just proposed?
It is proposed, not finalized. On December 11, 2025 the FDA issued a proposed administrative order to add bemotrizinol to monograph M020 at up to 6%, the first new active proposed for US sunscreens since the late 1990s. A comment period and finalization step remain before products could rely on it. The Environmental Working Group has welcomed it as a long-sought ingredient.
r/SkincareAddiction: 'How do I submit a comment on the bemotrizinol proposal before the January 2026 deadline, and does it even matter?'