Has DSM-Firmenich Put Us on a Path to a New U.S. Sunscreen Approval?

The health and beauty industry is in constant evolution, with new products, innovations, and regulations always on the horizon. One such significant development is DSM-Firmenich’s recent submission of the first-ever Over-the-Counter Monograph Order Request (OMOR) Tier 1 application to the U.S. Food Administration (FDA). This is a critical move by the company as it aims for its Parsol Shield (INCI: Bemotrizinol) sunscreen active to receive the generally recognized as safe and effective (GRASE) designation.

If successful, this would mean the inclusion of Parsol Shield in the U.S. over-the-counter (OTC) Sunscreen Monograph, marking the introduction of the first new sunscreen to this list in nearly 25 years. This innovative product is set to revolutionize the sunscreen industry, and we are about to delve into how and why.

DSM-Firmenich’s move to submit this application is significant. The concept of an OTC Monograph Order Request is a system through which the FDA can approve the sale of non-prescription drugs, such as sunscreen, without requiring each product to undergo a new drug approval process. It allows for a more streamlined approach to evaluate and endorse such products, and to ensure they are safe and effective for consumers.

The aim of DSM-Firmenich’s application is to have their Parsol Shield (INCI: Bemotrizinol) sunscreen active viewed as GRASE – generally recognized as safe and effective. This is an essential designation within the industry that signals the product has been thoroughly reviewed and found to be safe for general use, while also having a positive impact on specific health needs. It assures consumers that a product performs as advertised while offering minimal risk of adverse effects.

Including their sunscreen in the U.S. over-the-counter (OTC) Sunscreen Monograph, should the application be successful, is a remarkable step forward for DSM-Firmenich. The Sunscreen Monograph is a list of sunscreens thought to be safe for use without the need for a prescription or direct consultation with a healthcare provider. The introduction of a new sunscreen active to this list will refocus public and industry attention on the importance of sunscreen in maintaining skin health and preventing skin-related diseases.

It has been nearly 25 years since a new sunscreen was added to the U.S. OTC Sunscreen Monograph, symbolizing the weight of this potential development. The sunscreen industry is known to be notoriously slow-moving when it comes to new additions, further illustrating the considerable impact of DSM-Firmenich’s recent moves.

The sunscreen industry is a critical part of public health, with products offering vital protection against harmful UV rays, reducing the risk of skin cancer, and preventing prematurely aged skin. As such, the possible addition of DSM-Firmenich’s Parsol Shield to the OTC Sunscreen Monograph not only represents a win for the company but for the industry as a whole. It could potentially usher in a new era of sunscreen innovation.

As consumers, we look forward to seeing how this application progresses, as it carries the potential to transform the accessibility and effectiveness of sun protection products. The journey won’t be easy or fast, but with DSM-Firmenich at the helm, it’s an exciting time for the industry and sun lovers alike. Stay tuned for updates on this potential new addition to the sunscreen market making everyone’s summer brighter and safer.