DSM-Firmenich has made a significant advancement in 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 ingredient, PARSOL® Shield, also known as Bemotrizinol. This marks the beginning of a 17.5-month review process, during which the FDA will determine whether PARSOL® Shield can be classified as Generally Recognized as Safe and Effective (GRASE). If approved, it would be included in the U.S. Over-the-Counter (OTC) sunscreen monograph, a regulatory framework overseeing non-prescription sunscreens.
DSM-Firmenich submits its first OMOR application to the FDA for a patented sunscreen formulation, a move that could revolutionize the sunscreen market. This is especially significant because if granted approval, PARSOL® Shield would be the first new active sunscreen ingredient added to the U.S. OTC monograph in nearly 25 years. Such an approval could enhance the effectiveness of sunscreens available to consumers, raising the bar for sun protection and potentially playing a crucial role in skin cancer prevention.
Widely used outside the U.S. for over two decades, PARSOL® Shield is known for providing high-performance, broad-spectrum UV protection. Its potential inclusion in U.S. OTC products would elevate public health efforts to combat skin cancer, which is increasingly critical due to heightened exposure to UV radiation. DSM-Firmenich submits its first OMOR application to the FDA for a patented sunscreen formulation, aiming to improve the quality and reliability of sun care products in the U.S. market. Extensive safety and efficacy testing have shown its effectiveness, and its global use has demonstrated it as a trusted ingredient in sun care.
If the FDA grants approval, PARSOL® Shield could become a game-changer in the sunscreen industry, leading to innovation and more effective solutions for consumers looking to protect their skin from harmful UV rays.
