DSM Seeks FDA Approval for PARSOL® Shield as Sunscreen Active in the US

TAGS:  Sun Care   

The Personal Care & Aroma Ingredients business unit of DSM is preparing to submit the data to FDA in support of generally recognized as safe and effective (GRASE) determination for Bemotrizinol (BEMT).

DSM has been using BEMT as a sunscreen active globally in personal care cosmetic products since 2016, under the trade name PARSOL® Shield. But the use of BEMT in sunscreens is not yet approved, under the OTC Sunscreen Monograph in the United States, .

The company will be providing necessary scientific data to support FDA’s review and determination that BEMT is GRASE for use in over the counter (OTC) sunscreen products. DSM is hopeful that this action will result in inclusion of BEMT as the new sunscreen active ingredient in over twenty years.

PARSOL® Shield, High Performance UV Filter

• PARSOL® Shield (Bemotrizinol or BEMT) is a photostable broad-spectrum filter that efficiently provides UVB and UVA protection even at low concentrations.
• Its compatible with both organic and inorganic UV filters and is easy to use.
• The product is not available in USA.

Currently Approved Sunscreen Actives in US

• Only 16 UV filters are approved for use.
• According to the FDA’s new rule, Tentative Final Monograph (TFM), from the 16 currently approved OTC actives for sunscreens, only two – Zinc Oxide and Titanium Oxide - will be recognized by the FDA as “Generally Regarded as Safe and Effective” (GRASE) as of November 2019.
• The other ingredients will be required to generate further data to attain GRASE status.
• Otherwise, they will be eliminated from the market.

DSM’s ‘Safer Under the Sun’ Program

• DSM is working to increase awareness towards the importance of regular sun protection.
• The company believes that use of sunscreen is the proven and effective way to protect against skin cancers and skin damage caused by the sun’s rays.
• They want to make a significant contribution towards reducing the number of people living with preventable skin cancers by innovating sunscreen technology constantly.

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