New Sunscreen Filter, Bemotrizinol, on track for FDA Approval

by | Oct 28, 2025 | Cosmetics, FDA, OTC Drugs, Our View, Research/Science/Technology, U.S. Regulatory

A new sunscreen ingredient, bemotrizinol, is currently under review by the U.S. Food and Drug Administration (FDA) and could be the first new UV filter to be approved in the United States in decades. The European skincare company DSM-Firmenich has submitted a Time and Extent Application (TEA) for the ingredient, branded as PARSOL Shield, and a decision is expected by March 2026.

Bemotrizinol, also known as BEMT or Tinosorb S, is a broad spectrum, photostable UV filter that has been widely used in Europe and Asia for years. It protects against both UVA and UBV rays, which are responsible for sunburn, premature aging, and skin cancer. Unlike some older UV filters, bemotrizinol does not degrade in sunlight, meaning it remains effective for longer. It is also more fat-soluble, which helps it to provide better broad-spectrum protection.

The approval of bemotrizinol would give sunscreen manufacturers a new, effective tool to create safer and more effective products. It could also lead to more cosmetically elegant formulas that are less likely to leave a white cast on the skin, which would be a major benefit for people with darker skin tones.

If the FDA approves bemetrizinol, it could still be several months or even years before it is available in sunscreens on the U.S. market. This is due to the time it takes for manufacturers to formulate new products. Conduct stability testing and get them on store shelves. However, the potential approval of this new ingredient is a significant step forward for sun protection in the United States.