FDA Approves Bemotrizinol, the First New Sunscreen Ingredient in 25 Years

The U.S. Food and Drug Administration (FDA) has approved bemotrizinol, a new sunscreen ingredient, after a 25-year wait. This marks the first time a sunscreen component has passed through the agency’s updated review process. The move aims to improve sun protection options for consumers across the country. Bemotrizinol will enter the U.S. market under the brand name Parsol Shield, sold initially by DSM Nutritional Products. It is the first ingredient to clear the FDA’s streamlined pathway for sunscreen approvals, introduced in 2020. Unlike many existing products, it shields against both UVA and UVB rays while minimising skin irritation and absorption.

The ingredient offers longer-lasting protection and avoids the white streaks often left by other sunscreens. It has been deemed safe for adults and children aged six months and older. After an 18-month exclusivity period, other manufacturers will be able to incorporate bemotrizinol into their own products. Health and Human Services Secretary Robert F. Kennedy welcomed the decision, calling it a step forward for sunscreen innovation. The approval aligns with the FDA’s ongoing efforts to modernise sunscreen standards, including banning misleading labelling and requiring broad-spectrum protection.

Bemotrizinol’s arrival expands U.S. sun protection choices with a formula that balances effectiveness and safety. Its approval follows years of regulatory updates aimed at ensuring clearer, more reliable sunscreen options. The ingredient will soon be available in products nationwide, offering consumers an alternative to traditional formulations.