WASHINGTON – In a significant advancement for consumer health, federal health regulators have approved the first new sunscreen ingredient for the U.S. market in over 25 years. The Food and Drug Administration (FDA) announced on Tuesday that this new ingredient, known as bemotrizinol, will soon be available to American consumers, providing a chemical long utilized in Europe and other regions for effective skin protection.
The FDA confirmed that bemotrizinol meets rigorous safety standards, effectively protecting against harmful ultraviolet (UV) rays while minimizing skin irritation and absorption. Importantly, the ingredient is deemed safe for use by adults and children aged six months and older, marking a pivotal step in broadening the options available for sun protection.
Initially, bemotrizinol will be marketed in the U.S. by DSM Nutritional Products, a Dutch manufacturer, under the brand name Parsol Shield, with a launch anticipated later this year. Following an 18-month period of exclusivity, other manufacturers will also have the ability to utilize this ingredient in their sunscreen products.
The journey to introduce new sunscreen ingredients has been hindered for decades by the FDA’s intricate regulatory processes. Bemotrizinol is the first sunscreen ingredient to successfully navigate a streamlined procedure established by Congress in 2020, designed to expedite the approval of safe nonprescription drug ingredients.
Experts in dermatology and public health are optimistic about the introduction of bemotrizinol, as it is expected to fulfill a crucial need within the U.S. market. This ingredient provides protection against both ultraviolet A (UVA) and B (UVB) rays while avoiding the white residue often associated with mineral-based sunscreens. David Andrews, a representative from the Environmental Working Group, emphasized, “For decades, Americans have used outdated sunscreen technology while the rest of the world moved forward. The approval of bemotrizinol will help change that.”
Andrews’ organization has actively advocated for the FDA to enhance sunscreen standards and facilitate the introduction of new ingredients. Under existing FDA regulations, all sunscreens must offer protection against UVB rays, primarily responsible for sunburns, as well as UVA rays, which pose significant risks for skin cancer and premature aging.
Currently, the chemical ingredients available in the market tend to protect against either UVA or UVB rays. To achieve broad-spectrum protection, manufacturers typically blend various chemicals. In contrast, mineral-based sunscreens, such as those containing zinc oxide, effectively block both types of rays, but they often leave a noticeable chalky finish on the skin.
Bemotrizinol, which received approval from European authorities in 1999, was first submitted to the FDA for review in 2005. Dr. Mike Davis, acting director of the FDA’s drug center, stated, “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.”
The FDA has been progressively updating its standards for sunscreens. In 2011, the agency prohibited misleading terms like “waterproof” and mandated that all sunscreens must filter out both UVA and UVB rays. Previously, certain formulations only provided protection against UVB rays.
In 2021, the FDA proposed further measures to enhance sunscreen safety, including capping SPF numbers and requiring stronger UVA protection, although these proposals have yet to be finalized.
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