FDA approves long-used sunscreen already sold in Israel and Europe after 25-year dela

Key Points:

• The FDA has approved bemotrizinol (BEMT), a new sunscreen ingredient widely used in Europe since 1999, marking the first such approval in over 25 years; it protects against both UVA and UVB radiation and is safe for use in adults and children over six months old.
• Bemotrizinol addresses a key limitation of U.S. sunscreens by providing broad-spectrum protection and photostability, unlike many current U.S. chemical filters that mainly protect against UVB rays and degrade under sunlight.
• The ingredient's approval follows an accelerated FDA pathway established in 2020, overcoming decades of regulatory delays partly due to safety concerns about existing sunscreen chemicals that can enter the bloodstream.
• Bemotrizinol will be introduced to the U.S. market later this year by DSM Nutritional Products under the brand Parsol Shield, with an 18-month exclusivity period before other manufacturers can use it.
• Industry groups and experts have welcomed the approval but urge the FDA to continue modernizing sunscreen regulations, including finalizing broader reform proposals for clearer labeling and faster ingredient approvals.