The FDA's New Sunscreen Filter Was Evaluated as Safe for Babies 6 Months and Up
A next-generation UV filter used abroad for years is headed to US shelves - and unlike most chemical filters, it was specifically evaluated for babies 6 months and older.
In a proposed order issued December 12, 2025, the FDA stated it considers bemotrizinol GRASE at concentrations up to 6% for use by adults and children 6 months of age and older - the first new sunscreen active ingredient proposed for the US OTC monograph since 1999.
Dermatology commentators highlight that the proposed order explicitly addresses use in children 6 months and older, a notable detail given that standard guidance discourages sunscreen on infants younger than 6 months in favor of shade and clothing.
Questions we get a lot
Is bemotrizinol safe for babies?
The FDA's December 12, 2025 proposed order considers bemotrizinol GRASE at up to 6% for adults and children 6 months of age and older. That does not endorse it for infants under 6 months, for whom standard guidance still favors shade and protective clothing. Parents should follow product labeling and a pediatrician's advice.
How is this different from other chemical sunscreens?
Dermatology coverage notes that the proposed order explicitly addresses use in children 6 months and older, which is part of why the filter drew attention. Bemotrizinol is a broad-spectrum UVA/UVB active with low systemic absorption. As with any product, patch testing and label-reading remain sensible.
When was the last new US sunscreen active before this?
Dermatology reporting describes bemotrizinol as the first new sunscreen active ingredient proposed for the US OTC monograph since 1999. That roughly 25-year gap is why the proposal is considered a landmark. A final order would still be required before products appear.
r/beauty: 'Wait, the new bemotrizinol filter was actually evaluated for babies 6 months and up? Is that different from normal chemical sunscreens?'