The FDA has approved bemotrizinol, sold under the name PARSOL Shield, making it the first new sunscreen ingredient approved in the United States in over 20 years. The ingredient has been used safely in Europe and Asia for years, and its approval is expected to bring more effective sun protection products to American consumers by the end of 2026.
According to Healthline, bemotrizinol is a chemical sunscreen filter known for broad-spectrum UVA and UVB protection. It is photostable and effective at concentrations up to 6%. Unlike many older sunscreen filters, it is absorbed minimally through the skin.
HHS Secretary Robert F. Kennedy, Jr. commented on the approval, saying that "Bemotrizinol has been used safely in Europe for decades, and [the] FDA's action will increase competition and consumer confidence in sunscreen products."
The approval came through a streamlined process established by the CARES Act. It makes bemotrizinol the first new active ingredient added to an over-the-counter monograph under that process. The FDA said the approval fits within its broader commitment to modernizing sunscreen regulation, which it acknowledged had fallen behind other countries.
The FDA also stated: "This is exactly the kind of progress we can achieve when we modernize our processes and apply sound science to regulatory decisions," and that it is "committed to ensuring the American consumer has access to the most effective and safe therapies, including over-the-counter products like sunscreens."
Susan Mayou, a consultant dermatologist at the Cadogan Clinic in the United Kingdom, told Healthline the approval fills a real gap. "It introduces a modern UV filter that has been used safely and effectively in Europe and other parts of the world for many years. One longstanding criticism of the U.S. sunscreen market has been that consumers have had access to fewer advanced UV filters than those available internationally," she said.
Mayou added that "some of the newer filters available in Europe and elsewhere offer stronger UVA protection, improved stability in sunlight, and more cosmetically elegant formulations," while noting that existing U.S. sunscreens can still provide excellent protection when used correctly.
The approval also aligns with what the Make America Health Again strategy report identified as a priority: that the FDA promote innovation in the sunscreen market and improve regulatory processes for over-the-counter sunscreen products. The report specifically noted that U.S. sunscreen regulation had fallen behind other countries.
Products featuring PARSOL Shield are expected to reach U.S. store shelves before the end of 2026, with broader availability to follow after that.
