FDA Approves First New US Sunscreen Ingredient in Decades

The U.S. Food and Drug Administration approved the UV filter bemotrizinol for use in over-the-counter sunscreen products on June 9, 2026 ^[1].

This decision marks a significant shift in American skincare regulation by introducing a modern filter previously unavailable in the U.S. market. The approval aims to expand protection options for consumers by utilizing an ingredient that has already been proven effective in other global regions ^[2].

Bemotrizinol, which is also known as Tinosorb M, is a broad-spectrum UV filter ^[3]. The ingredient has been used safely and extensively in sunscreen formulations across Europe and Asia for years ^[2]. By allowing its use in the United States, the FDA is bringing the U.S. market closer to international standards for sun protection ^[3].

Industry observers said this is the first time the agency has approved a new sunscreen ingredient in a significant amount of time. Reports on the exact duration of the hiatus vary; some sources state it has been more than 25 years ^[1], while others cite a 20-year gap ^[5].

The approval allows manufacturers to incorporate bemotrizinol into a variety of over-the-counter products. This move is expected to provide American consumers with more stable and effective options for preventing skin damage and reducing the risk of skin cancer ^[2].

Because the filter is already established in other markets, the transition for manufacturers is expected to be streamlined. The addition of bemotrizinol provides a new tool for formulating sunscreens that are more resistant to degradation under sunlight, a common challenge with older UV filters ^[3].