In a exciting move for the US personal care and cosmetics industry, dsm-firmenich has submitted the first-ever Over-the-Counter Monograph Order Request (OMOR) Tier 1 application to the US Food and Drug Administration (FDA) for its sunscreen active ingredient, PARSOL Shield, known as Bemotrizinol (BEMT). This submission initiates a 17.5-month review by the FDA to determine whether BEMT will be classified as Generally Recognized as Safe and Effective (GRASE), potentially becoming the first sunscreen active ingredient to be added to the US OTC sunscreen monograph in nearly 25 years, according to the company's press release.
The FDA’s decision could have far-reaching implications for cosmetics and personal care product manufacturers, offering them a new, high-performance UV filter that has been widely used in other global markets since 2000. For manufacturers and suppliers, the introduction of PARSOL Shield in the US could significantly enhance product offerings by incorporating a globally proven sunscreen ingredient with advanced photostability and broad-spectrum coverage.
A rigorous FDA submission process
dsm-firmenich's D'Ruiz shared details about the data supporting the safety and effectiveness of PARSOL Shield. “DSM conducted the relevant studies, trials, and gathered supporting data for the proposed monograph change under a confidential Investigation New Drug (IND) application,” he said.
He noted that the OMOR Tier 1 submission followed the FDA’s 2023 guidelines and included extensive pharmacological, clinical, and toxicological information required for the GRASE determination, "including those outlined in 'Nonprescription Sunscreen Drug Products' and 'Guidance on Maximal Usage Trials' (MUsT)."
PARSOL Shield’s approval would address growing demand in the US sun care market by providing a photostable and efficient UV filter for broad-spectrum protection. According to D'Ruiz, “The inclusion of BEMT 6% in the OTC sunscreen drug monograph aims to meet the unmet need for a photostable UVA and UVB filter in the US market, thereby expanding consumer sunscreen options with more aesthetically desirable formulations and enhancing public health protection against harmful UV radiation.”
Implications for product formulations
For US manufacturers, the potential approval of PARSOL Shield opens up significant opportunities. BEMT’s high photostability and synergistic compatibility with other sunscreen actives make it a highly efficient ingredient for modern sunscreen formulations. “Unlike some UV filters that degrade under sunlight, Bemotrizinol remains stable, ensuring long-lasting protection,” D'Ruiz stated.
He emphasized that PARSOL Shield’s physical and chemical properties, including its high molecular weight, which reduces skin penetration and minimizes systemic absorption, further enhance its safety profile.
D'Ruiz also highlighted BEMT’s compatibility with other filters like Avobenzone, saying, “It significantly stabilizes Avobenzone, enhancing its photostability and ensuring more reliable and prolonged UVA protection in sunscreen formulations.”
These properties make PARSOL Shield a versatile and valuable addition to the US market, where the demand for high-performance sunscreen ingredients is increasing. Additionally, BEMT’s long history of safe use and market experience further reinforces its potential as a key ingredient for personal care products. “BEMT’s long-standing global marketing experience, backed by comprehensive safety data and post-market surveillance, demonstrates its effectiveness and safety,” D'Ruiz said.
Impact of FDA’s updated safety standards
D'Ruiz also provided insights into how the FDA’s updated GRASE and MUsT requirements are reshaping innovation in sunscreen active ingredients. "The updated standards emphasize demonstrating long-term safety, particularly with MUsT testing to assess systemic absorption under maximal usage conditions," he noted.
This means more rigorous safety data will be required for both new and existing ingredients, which could increase R&D costs and extend development timelines.
However, “the FDA’s focus on safety and efficacy will likely stimulate innovation in sustainable and environmentally friendly sunscreen ingredients,” D'Ruiz added, emphasizing that environmental safety is increasingly tied to product safety, particularly concerning issues like coral reef health.
A new era for sunscreen in the US
If approved, PARSOL Shield will be the first new sunscreen active ingredient added to the US OTC sunscreen monograph since 1999, potentially setting a new benchmark for the industry. “This OMOR submission marks a monumental step in dsm-firmenich’s commitment to driving innovation in sun care, consumer health, and sustainability,” said Parand Salmassinia, President of Beauty & Care at dsm-firmenich, in the press release.
He added, "If approved, it will elevate the standard of sun protection and play a vital role in public health and skin cancer prevention.”
For cosmetics and personal care manufacturers, the potential GRASE approval represents a significant development, allowing for the integration of a highly effective and trusted sunscreen active ingredient into US formulations without the need for additional pre-market approval. With PARSOL Shield already widely used in global markets, US consumers may soon have access to this innovative technology, further boosting efforts to enhance sun protection and prevent skin cancer.
As the FDA review process continues, many eyes in the industry will be on the potential approval of Bemotrizinol and the new opportunities it could bring to the US sunscreen and personal care markets.
