On June 9, 2026, the US Food Old as and Drug Administration (FDA) approved bemotrizinol, marking the first new sunscreen ingredient for over-the-counter use in the US since 1999. This approval is significant as bemotrizinol, while new to the U.S. market, has been safely and effectively used in Europe and Asia for decades, with European regulators approving it in 2000.
Bemotrizinol is a broad-spectrum UV filter, meaning it protects against both UVA and UVB rays, eliminating the need to combine it with other ingredients for comprehensive protection. A key advantage is its photostability, allowing it to last for four to eight hours before reapplication, unlike older chemical sunscreens that often require reapplication every two hours. Its molecules are also larger, preferring to sit on the skin's surface and reducing absorption into the bloodstream, a concern with some previously approved formulations. It has also been designated safe and effective for children as young as 6 months.
The regulatory process for new sunscreen ingredients in the US has been notoriously slow, with the FDA regulating sunscreens as over-the-counter drugs rather than cosmetics, unlike many other countries. This has resulted in the US lagging behind with only 16 approved active ingredients prior to bemotrizinol. The speedy approval of bemotrizinol, occurring within seven months of the request, is attributed to a combination of legislative pressure, such as the 2025 SAFE Sunscreen Act, and the Trump Administration's MAHA Strategy Report aimed at modernizing regulatory processes. Manufacturers can begin incorporating bemotrizinol, which will be available under brand names like Parasol Shield (from DSM-Firmenich AG) and Tinosorb S (from BASF outside the US), into products as early as August 9, 2026, although availability on U.S. shelves is expected later in 2026 or early 2028.
Dermatologists generally recommend sunscreens with an SPF of 30 or higher for broad-spectrum protection. While bemotrizinol offers a welcome organic option that is largely invisible and not easily absorbed, some experts still lean towards inorganic, mineral-based sunscreens containing zinc oxide or titanium dioxide due to minimal evidence of their absorption into the skin. The approval of bemotrizinol provides consumers with a more effective and stable choice, potentially increasing sunscreen compliance due to its longer efficacy and broad-spectrum protection. However, the U.S. still has fewer approved sunscreen ingredients compared to other countries.
