The FDA Updates Sunscreen Regulations, But Bemotrizinol Approval Remains Uncertain
The U.S. Food and Drug Administration (FDA) has finalized updates to its sunscreen monograph, a regulatory framework that governs the safety and efficacy of over-the-counter sunscreens, according to a June 2023 press release. However, claims that the agency has approved the chemical bemotrizinol for use in sunscreens appear to be inaccurate, as no official documentation confirms this approval as of 2023.
The updated monograph includes new requirements for sunscreens to be labeled as “broad-spectrum,” meaning they protect against both UVA and UVB rays, and sets limits on the concentration of certain active ingredients. The FDA also emphasized the importance of sunscreens being “water-resistant” for at least 40 or 80 minutes, depending on the product.
What Is Bemotrizinol, and Why the Confusion?
Bemotrizinol, a benzotriazole derivative, is a UV filter used in some European and Asian sunscreens. It is known for its long-lasting protection against UV radiation, which can cause premature skin aging and skin cancer. However, the FDA has not granted final approval for its use in the United States.
According to the FDA’s 2023 sunscreen monograph, the agency has not yet evaluated bemotrizinol for safety and efficacy under U.S. standards. “The FDA continues to review data on new sunscreen ingredients, but no final decision has been made on bemotrizinol,” a spokesperson stated in a June 2023 email.
How Does the FDA Approve Sunscreen Ingredients?
The FDA’s approval process for sunscreen ingredients is rigorous. To be included in the monograph, a chemical must undergo extensive testing to ensure it is safe for human use and effective in blocking harmful UV rays. As of 2023, the FDA has approved 16 active ingredients for sunscreen, including avobenzone, oxybenzone, and titanium dioxide.
Bemotrizinol, while approved in the European Union and some other regions, has not met the FDA’s current criteria for inclusion. The agency has raised concerns about its potential for skin absorption and long-term effects, which require further study.
What Does This Mean for Consumers?
Consumers should be cautious about products labeled