First New Sunscreen Ingredient Approved by FDA in 20 Years - Available on Covalo

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• Two decades of regulatory stagnation — now over
• What makes PARSOL® Shield significant for formulators
• A new era for U.S. sun care
• Find PARSOL® Shield on Covalo

This is a landmark moment for sun care formulation in the United States, and one with real implications for every brand, formulator, and supplier working in this space.

Two decades of regulatory stagnation — now over

Unlike most of the world, the U.S. regulates sunscreens as over-the-counter (OTC) drugs rather than cosmetics. This has historically made it more difficult — and slower — to add new UV filters to the permitted list. The last new active ingredient was added to the OTC sunscreen monograph in the late 1990s. Since then, formulators in the U.S. have been working with a limited toolbox while their counterparts in Europe and Asia have had access to a much broader palette of modern UV filters. 

PARSOL® Shield changes that. Bemotrizinol has been a staple ingredient in European and Asian sunscreens for decades, used safely in products worldwide; dsm-firmenich spent more than 20 years and approximately 20 million USD navigating the U.S. regulatory process to bring it here. The FDA finalized approval in just seven months after issuing a proposed order in December 2025, under a pathway established by the CARES act. 

What makes PARSOL® Shield significant for formulators

True broad-spectrum protection: Bemotrizinol is a chemical UV filter that protects against both UVA and UVB rays. This matters, because existing U.S.-approved sunscreens have long had a well-documented UVA gap. Research by the Environmental Working Group found that U.S. sunscreens deliver on average only 24% of the UVA protection implied by their SPF labels. PARSOL® Shield directly addresses that gap.

Exceptional photostability: One of the persistent challenges for U.S. formulators working with avobenzone — currently the only non-mineral filter providing meaningful UVA coverage in the U.S. — is its tendency to degrade under UV exposure. Bemotrizinol is highly photostable, meaning it maintains its protective efficacy throughout wear. No degradation, no compromise. 

Formulation flexibility: Already proven in global markets, PARSOL® Shield enables formulators to create lightweight, elegant sunscreen texturesthat have been harder to achieve with the existing U.S.-approved filter set. For brands pursuing globally scalable formulations (in other words, products that can be sold in the U.S. and beyond), this is a significant practical advantage.

Demonstrated safety: Clinical studies involving nearly 500 participants have demonstrated strong UV efficacy, excellent tolerability, and a robust safety profile. The ingredient also shows low levels of absorption through the skin into the body.

Approved for adults and children 6 months and older: The FDA's clearance covers use in sunscreens for adults and children from six months of age, meaning PARSOL® Shield can be incorporated into products across the full consumer range, from everyday SPF moisturizers to dedicated sun care lines.

A new era for U.S. sun care

The approval has been welcomed across the industry. The Personal Care Products Council called it a "critical step toward modernizing the U.S. sunscreen landscape, increasing consumer choice, and providing tools to support skin cancer prevention". The Environmental Working Group described it as "the most significant step in a generation toward fixing that [the UVA protection] problem". 

The FDA's own acting director of the Center for Drug Evaluation and Research framed it as proof of what's possible when regulatory processes are modernized and sound science is applied to decision-making. The approval also validates the CARES Act monograph pathway, potentially opening the door for other long-stalled UV filters to follow.

For formulators and brands the message is clear: the 20-year wait is finally over. 

Find Parsol® Shield on Covalo

Parsol® Shield by dsm-firmenich is listed on the Covalo marketplace. Cosmetic formulators, R&D teams, and ingredient buyers can explore the full ingredient profile, request samples, and get in touch with the supplier directly. 

👉 Discover PARSOL® Shield on Covalo