Recently, DSM-Firmenich has taken a significant step in advancing sun protection by submitting its first Over-the-Counter Monograph Order Request (OMOR) Tier 1 application to the U.S. Food and Drug Administration (FDA) for its high-performance sunscreen active ingredient, PARSOL® Shield, also known under its United States Adopted Name (USAN), Bemotrizinol. This submission marks the start of a comprehensive 17.5-month review process, during which the FDA will assess whether PARSOL® Shield can be classified as Generally Recognized as Safe and Effective (GRASE). If granted this designation, the ingredient will become eligible for inclusion in the U.S. Over-the-Counter (OTC) sunscreen monograph, a regulatory framework that governs the formulation of sunscreens sold without a prescription.
This development is particularly noteworthy because, if approved, PARSOL® Shield would be the first new active sunscreen ingredient added to the U.S. OTC monograph in nearly 25 years. The inclusion of this advanced ingredient could significantly enhance the efficacy of sunscreens available to U.S. consumers, raising the standard of sun protection and contributing to the prevention of skin cancer. The approval of a new active ingredient could also stimulate innovation within the sunscreen market, offering consumers more effective and reliable options for protecting their skin against harmful ultraviolet (UV) radiation.
PARSOL® Shield has been widely used in markets outside the U.S. for over two decades, and it is recognized for its high performance in providing broad-spectrum UV protection. Its inclusion in U.S. OTC products could elevate public health efforts aimed at reducing the incidence of skin cancer, which is a growing concern due to increased exposure to UV rays and insufficient protection in existing sunscreen products. The active ingredient has undergone extensive safety and efficacy testing, and its global use has demonstrated its reliability as a key component in sun care products
