Bemotrizinol's Dec 2025 Proposal Is Also a Contamination Story
Modern, stable UV filters are the long-term antidote to 2025's benzene-and-overclaim recalls - and in December the US finally moved to approve one Europe and Asia have used for years.
On December 12, 2025 the FDA issued a proposed order (OTC000039) to add bemotrizinol to OTC Monograph M020 as GRASE at up to 6%, citing broad-spectrum UVA/UVB protection and low systemic absorption - the first new active sunscreen ingredient proposed for the US monograph since the late 1990s, with comments open through January 26, 2026.
Legal and regulatory commentators describe the proposal as the most consequential US sunscreen development in years, noting bemotrizinol's broad-spectrum coverage and low systemic absorption.
Questions we get a lot
What concentration of bemotrizinol did the FDA propose?
The FDA's December 12, 2025 proposed order would recognize bemotrizinol as generally recognized as safe and effective at concentrations up to 6%. The order cites broad-spectrum UVA/UVB protection and low systemic absorption. A public comment period stayed open through January 26, 2026.
How does a new filter relate to sunscreen recalls?
Recent sunscreen recalls have involved contamination and overclaimed SPF rather than the filters themselves, but a modern, well-characterized active broadens the formulating toolkit. Regulatory analysts describe bemotrizinol as a significant addition to the US monograph. Adding stable, broad-spectrum options can support more robust formulations over time.
When was the last new US sunscreen filter added?
Coverage of the proposal notes that no new active sunscreen ingredient had been added to the US monograph since the late 1990s. That long gap is why the bemotrizinol proposal drew so much attention. The December 12, 2025 order would be the first new active in roughly a quarter century.
r/30PlusSkinCare: 'After all the benzene recalls, I don't trust half my sunscreens anymore - would a newer filter like bemotrizinol actually be more stable?'