FDA Proposes Introduction of a Revolutionary Sunscreen Ingredient After More Than Two Decades
The U.S. Food and Drug Administration (FDA) recently proposed an administrative order in December 2025, potentially introducing a sunscreen ingredient to American consumers that has been in use abroad for several decades. If this order is finalized, bemotrizinol (BEMT) will become the first new active sunscreen ingredient approved in the United States since 1999.
Bemotrizinol offers broad-spectrum protection against both UVA and UVB rays. It is significantly more photostable than the currently U.S.-approved chemical sunscreen ingredients, meaning it breaks down less quickly when exposed to light. According to the FDA review, the ingredient has low levels of absorption through the skin into the body and rarely causes skin irritation.
“Bemotrizinol would be a welcome addition to the current array of effective sunscreen active ingredients already available to American consumers,” said Dr. Karen Murry, Acting Director of the Office of Nonprescription Drugs at the FDA.
The ingredient would be permitted at concentrations up to 6% and would become only the third sunscreen ingredient considered safe for use in children as young as 6 months, alongside zinc oxide and titanium dioxide. Bemotrizinol has been approved in Europe since 2000 and is currently used in many sunscreen products in Australia, Europe, and parts of Asia.
The FDA is accepting public comments on the proposed order until January 26, 2026. According to an FDA spokesperson, the agency anticipates issuing a final order in summer or fall 2026, which could allow manufacturers to start marketing products with BEMT as early as late 2026.
Source: FDA Press Release