US Recommends Bemotrizinol, a Popular Ingredient in Europe and Asia

On October 2023, a noteworthy proposal from the US Food and Drug Administration (FDA) may significantly alter the landscape of sunscreens in the United States. The FDA has recommended the incorporation of Bemotrizinol, a chemical widely embraced in Europe, Australia, and Asia, into US sunscreens.

Bemotrizinol: A Broad-Spectrum Sun Protection Agent

Bemotrizinol promises enhanced protection against both Ultraviolet A (UVA) and Ultraviolet B (UVB) rays. Experts assert that this ingredient could outperform many existing US-approved sunscreen products. FDA Commissioner Marty Makary emphasized the urgency for the FDA to expedite approvals for new sunscreen technologies. He expressed concerns that the slow pace has limited options for American consumers compared to those in other countries.

Proposed Regulations for Bemotrizinol

The FDA’s proposal allows manufacturers to use Bemotrizinol concentrations of up to 6%. Dr. Makary stated, “Americans deserve timely access to the best safe, effective, and consumer-friendly over-the-counter products available.”

Support from FDA Officials

• Karen Murry, acting director of the US Office of Nonprescription Drugs, welcomed the addition of Bemotrizinol.
• She indicated a commitment to work with companies to facilitate the market entry of products featuring new active ingredients across various therapeutic areas.

The Regulatory Landscape of Sunscreens

In the United States, sunscreens are classified as non-prescription drugs. This classification necessitates a lengthy regulatory process, creating hurdles for innovation. Conversely, the European Union categorizes sunscreens as cosmetics, streamlining approval timelines and allowing quicker access to new formulations.

The Importance of Sunscreen

Regular sunscreen use is critical for preventing skin cancer and reducing premature aging. Health professionals, including those in the UK, highlight that most individuals do not apply sufficient amounts of sunscreen. Along with using sunscreen, they recommend wearing sunglasses, protective clothing, and hats to shield against UV damage.

Statistics and Health Implications

Skin cancer remains the most prevalent cancer in the United States. According to the Centers for Disease Control and Prevention (CDC), approximately 6.1 million adults receive treatment annually for basal cell and squamous cell carcinomas. This statistic underscores the necessity of effective sun protection measures.