WASHINGTON — The US Food and Drug Administration has approved bemotrizinol, the first new sunscreen ultraviolet filter cleared for the American market in 27 years. The broad-spectrum ingredient can now be used in over-the-counter products.
Bemotrizinol protects against both UVA and UVB radiation and has been marketed in Europe and Asia for years. Regulatory hurdles had kept the American sunscreen market reliant on older chemistries, a gap dermatologists have repeatedly criticised.
DSM-Firmenich, which manufactures the ingredient under the trade name Parsol Shield, drove the approval through a regulatory pathway. The company submitted extensive safety and photostability data to the FDA. Bemotrizinol's slow degradation under sunlight improves protection over time.
The American Academy of Dermatology has previously urged the FDA to modernise its list of approved filters, noting that the last new active ingredient was cleared in the late 1990s. Industry observers said the approval could accelerate further filter applications now pending before regulators.
Manufacturers said reformulated products containing bemotrizinol could reach US shelves within months, pending labelling and production. The move brings American sunscreen standards closer to those long available across the European Union and East Asia.