DSM-Firmenich PARSOL Shield gains FDA approval as first new sunscreen active in 25 years

DSM-Firmenich has received FDA approval for bemotrizinol (brand name PARSOL Shield), the first new sunscreen active ingredient approved in the United States in more than 25 years. The approval opens formulation options for sunscreen aerosol manufacturers seeking next-generation UV protection platforms.

PARSOL Shield was evaluated under modernised FDA GRASE (Generally Recognised as Safe and Effective) and MUsT (Maximal Usage Trial) guidelines.

Clinical trials involving approximately 500 participants demonstrated broad-spectrum UV efficacy, excellent tolerability and a strong safety profile across diverse population demographics.

From an aerosol formulation perspective, PARSOL® Shield enables development of lightweight, silky textures with strong photostability and enhanced formulation flexibility.

The ingredient's high efficiency at low concentrations contributes to reduced formulation complexity, supporting aerosol spray delivery systems requiring minimal active ingredient concentration for effective coverage.

The approval reinforces a significant innovation gap in the US sunscreen market. Prior to PARSOL Shield, no new sunscreen actives had gained FDA approval since the early 2000s, constraining product development across conventional and aerosol delivery formats.

PARSOL Shield is already approved across multiple global regions, enabling development of globally-scalable sunscreen aerosol formulations that simplify product strategy and reduce time-to-market for manufacturers pursuing international distribution.

From a sustainability perspective, PARSOL Shield's broad-spectrum protection and high efficiency at low concentrations contribute to reduced environmental impact per application compared to conventional sunscreen actives, supporting industry alignment with evolving sustainability reporting requirements and regulatory expectations.

Parand Salmassinia, Beauty & Care President at dsm-firmenich, noted that the approval delivers formulation flexibility manufacturers have sought for decades and enables next-generation aerosol sunscreen development addressing consumer expectations for texture, efficacy and environmental sustainability.