New sunscreen ingredient wins FDA approval after years of delay

The Food and Drug Administration (FDA) has recently approved bemotrizinol as the first new sunscreen ingredient to enter the U.S. market in over 25 years. This decision, announced on Tuesday, will provide Americans with access to a skin-protecting chemical that has been widely used in Europe and other parts of the world.

Bemotrizinol has met the FDA’s strict standards for protecting against harmful ultraviolet rays while causing minimal irritation and absorption into the skin. The ingredient is deemed safe for both adults and children aged 6 months and older, according to a statement released by the FDA. Dutch manufacturer DSM Nutritional Products will be introducing bemotrizinol to the U.S. market under the brand name Parsol Shield, with an expected launch later this year. Following an 18-month exclusivity period, other manufacturers will also be able to utilize this ingredient in their sunscreen products.

The introduction of bemotrizinol marks a significant milestone in the sunscreen industry, as efforts to bring new sunscreen products to market have been hampered by the FDA’s cumbersome process for updating its lists of approved nonprescription drug ingredients. Bemotrizinol is the first ingredient to undergo a streamlined approval process authorized by Congress in 2020.

Health and Human Services Secretary Robert F. Kennedy, who oversees the FDA, commended the decision for promoting innovation and offering consumers a new option for sun protection. He stated, “Bemotrizinol has a proven safety record in Europe for many years, and the FDA’s approval will enhance competition and bolster consumer confidence in sunscreen products.”

Experts anticipate that bemotrizinol will address a crucial need in the U.S. market by providing protection against both UVA and UVB rays without leaving behind the white streaks often associated with mineral-based sunscreens. CBS News chief medical correspondent Dr. Jon LaPook noted that bemotrizinol is more resilient to sun exposure compared to existing sunscreens, resulting in longer-lasting protection.

David Andrews from the Environmental Working Group lauded the FDA’s decision, stating, “For decades, Americans have been using outdated sunscreen technology while the rest of the world has progressed. The approval of bemotrizinol will help change that.”

Currently, sunscreen products on the market typically combine chemical-blocking ingredients to achieve broad-spectrum protection against UVA and UVB rays. Mineral-based ingredients like zinc oxide offer similar protection but can leave a visible white residue on the skin. Bemotrizinol, which was authorized by European authorities in 1999, was first submitted for FDA review in 2005. DSM conducted additional studies on the ingredient in response to FDA requests in 2019.

The FDA’s decision to approve bemotrizinol underscores the agency’s commitment to ensuring that Americans have access to safe and effective over-the-counter products like sunscreens. The FDA has been progressively updating its sunscreen standards, such as banning misleading terms like “waterproof” in 2011 and requiring all sunscreens to protect against both UVA and UVB rays.

While the FDA proposed further measures in 2021, such as capping SPF numbers and enhancing UVA protection, these initiatives have yet to be finalized. Overall, the approval of bemotrizinol represents a significant step forward in the sunscreen industry, offering consumers a new and advanced option for sun protection.