FDA Approves First New Sunscreen Ingredient In Over 20 Years

The Food and Drug Administration (FDA) has approved bemotrizinol, a new sunscreen ingredient, marking the first addition of its kind to U.S. products in more than 20 years. The decision, announced Tuesday (June 9), is expected to expand sun protection options for Americans and help address the country’s high rates of skin cancer.

Bemotrizinol is a broad-spectrum ultraviolet (UV) filter that protects against both UVA and UVB rays. It is already widely used in Europe, Asia, and Australia, but until now, Americans have not had access to sunscreens containing this ingredient. The FDA’s move comes after extensive safety and effectiveness reviews, including studies that found bemotrizinol minimally absorbed by the body and not linked to skin irritation, cancer, or reproductive harm.

In the United States, sunscreens are regulated as over-the-counter drugs. This has made it more difficult for new ingredients to be approved compared to other countries, where sunscreen is often classified as a cosmetic. The FDA’s review process for bemotrizinol began after recent legislative changes, such as the SAFE Sunscreen Standards Act, which allowed the agency to consider real-world evidence from other countries where the ingredient has been safely used for years. According to Healio, these reforms sped up the approval of bemotrizinol, which is marketed internationally under names like Tinosorb S and Parsol Shield.

Dermatology experts say bemotrizinol addresses a critical “protection gap” in American sunscreens, especially against UVA rays, which penetrate deeper into the skin and are linked to premature aging and skin cancer. U.S. skin cancer rates are among the highest in the world, with more than 100,000 cases in 2022. The new ingredient could help lower these numbers by providing broader and longer-lasting protection than many existing products.

Bemotrizinol is stable in sunlight, can be combined with mineral filters like zinc oxide, and enables more user-friendly sunscreen formulations, such as gels and sheer lotions for all skin types. The FDA’s approval allows bemotrizinol to be used at concentrations up to six percent and prohibits its combination with certain other filters considered less safe.

For now, DSM-Firmenich, which markets bemotrizinol as Parsol Shield, will have 18 months of exclusive marketing before other manufacturers can use the ingredient.

Americans will likely see new sunscreens with bemotrizinol on store shelves by the end of summer 2026.