FDA Approves ‘New’ Sunscreen Ingredient Used in Europe and Asia for Years

• The FDA has approved bemotrizinol (PARSOL Shield). This is the first new sunscreen ingredient approved in over 20 years, offering superior UVA and UVB protection.
• Consumers in the United States can expect new products featuring PARSOL Shield by the end of 2026, with broader availability to follow.
• This innovation closes the UVA protection gap and paves the way for more effective, cosmetically elegant sunscreens.

The Food and Drug Administration (FDA) has approved bemotrizinol (PARSOL Shield), an advanced sunscreen filter that has long been used in Europe and Asia. 

It is the first new sunscreen ingredient approved by the FDA in over 20 years and will offer consumers improved UVA protection. It will also pave the way for a new generation of sunscreens. 

“Bemotrizinol has been used safely in Europe for decades, and [the] FDA’s action will increase competition and consumer confidence in sunscreen products,” HHS Secretary Robert F. Kennedy, Jr said in a press release. 

Bemotrizinol (PARSOL Shield) is a chemical sunscreen filter that is recognized for its broad-spectrum UVA and UVB protection. It is photostable and effective at concentrations up to 6%.

Unlike many older filters, bemotrizinol is absorbed minimally through the skin, with plasma levels rarely exceeding FDA thresholds.

“This is exactly the kind of progress we can achieve when we modernize our processes and apply sound science to regulatory decisions,” Mike Davis, MD, Acting Director of the FDA Center for Drug Evaluation and Research (CDER), said in a press release.

“The FDA is committed to ensuring the American consumer has access to the most effective and safe therapies, including over-the-counter products like sunscreens.”

Why FDA approval of bemotrizinol is significant

Bemotrizinol is the first new active ingredient added to an over-the-counter (OTC) monograph under the streamlined process established by the CARES Act. 

The approval of bemotrizinol aligns with the Make America Health Again (MAHA) strategy report priority that states, “FDA will promote innovation in the sunscreen market, and improve regulatory processes for over-the-counter sunscreen, which has fallen behind other countries.”

Susan Mayou, a consultant dermatologist at the Cadogan Clinic in the United Kingdom, told Healthline that this FDA approval is an important development. 

“It introduces a modern UV filter that has been used safely and effectively in Europe and other parts of the world for many years. One longstanding criticism of the U.S. sunscreen market has been that consumers have had access to fewer advanced UV filters than those available internationally,” she said. 

“While existing U.S. sunscreens can provide excellent protection when used correctly, some of the newer filters available in Europe and elsewhere offer stronger UVA protection, improved stability in sunlight, and more cosmetically elegant formulations.”

 The first products in the United States with the new ingredient are expected by the end of 2026 under the PARSOL Shield name.

How does bemotrizinol work differently? 

Bemotrizinol offers true broad-spectrum coverage and is highly photostable, meaning it does not degrade in sunlight. 

It is suitable for sensitive skin, with low risk of irritation and minimal systemic absorption. Formulations can be lighter and less likely to leave a white cast, especially compared to mineral-only sunscreens.

“Unlike some older UV filters that protect only a narrow portion of the ultraviolet spectrum, bemotrizinol offers broad-spectrum coverage across both UVA and UVB rays,” said Mayou. 

“This is particularly important because UVB rays are primarily responsible for sunburn, while UVA rays penetrate deeper into the skin and contribute to premature aging, pigmentation, and skin cancer.”

Mayou also told Healthline that bemotrizinol “is also highly efficient, providing strong protection at relatively low concentrations.” 

“This gives formulators greater flexibility to create sunscreens that are lightweight, comfortable to wear, and cosmetically elegant, without sacrificing protection. Ultimately, this can lead to products that people are more likely to apply correctly and use consistently, which is one of the most important factors in effective sun protection.”