News Alert

DSM seeks FDA approval of PARSOL® SHIELD as a new sunscreen active for use in OTC sunscreen products in the US

Parsippany (USA), 29 Aug 2019 02:30 CET

DSM’s Personal Care & Aroma Ingredients business unit, one of the industry’s leading suppliers to the personal care, home care and fine fragrance markets, prepares to submit the necessary data to the FDA to support a generally recognized as safe and effective (GRASE) determination for Bemotrizinol (BEMT).

DSM to provide data in support of a GRASE determination for BEMT

Under the trade name PARSOL® Shield, DSM has been providing Bemotrizinol (BEMT) as a UV light absorber for use in sunscreens and personal care cosmetic products since 2016. BEMT has been used globally as a UV light absorber since 1999, but it is not approved for sunscreen use under the OTC Sunscreen Monograph in the United States.

DSM has met with the FDA and will be providing it with the necessary scientific data to support FDA’s review and determination that BEMT is generally recognized as safe and effective (GRASE) for over the counter (OTC) sunscreen product use. The company hopes that this action will result in the inclusion of BEMT as the first new sunscreen active ingredient in over twenty years; Avobenzone having been one of the last sunscreen actives to be included in 1999.

Minutes from the meeting can be found on the FDA’s Regulations.Gov website.

The role of modern UV filters in helping to encourage safe sun protection habits

PARSOL® Shield (Bemotrizinol or BEMT) is a photostable broad-spectrum filter that efficiently provides UVB and UVA protection even at low concentrations. It is easy to use and compatible with both organic and inorganic UV filters. At present, it is not available in the USA where just 16 UV filters are currently approved for use compared with 27 in the EU. Furthermore, as per the FDA’s proposed new rule, Tentative Final Monograph (TFM), of the 16 currently approved OTC active ingredients 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 others will be required to have further data generated to attain GRASE status or will be eliminated from use in the US market. Elimination of these ingredients would significantly limit sun protection options for formulators and consumers alike.

DSM believes it is important for consumers in the USA to be able to benefit from the broad-spectrum UV protection and sensory properties that modern filters such as BEMT can provide. Studies show compelling evidence that the unpleasant skin sensations known for traditional sunscreens are one of the main barriers to consumers using adequate amounts of sunscreen and re-applying it frequently enough for optimum protection. By introducing the option to formulate sun care products that feel light and pleasant on the skin this barrier could be removed.

Staying safe with sun protection

Through its “Safer under the sun” program DSM is working to raise awareness of the importance of regular sun protection. This is crucial in the United States where only 14% of US men and 30% of US women currently use sunscreens daily1 yet there is a 20% chance of developing skin cancer by the age of 652. DSM believes that sunscreen use is a proven and effective way to protect against skin cancers and skin damage caused by the sun’s rays and is committed to supporting the safety and availability of existing and new sunscreen active ingredients globally and in the USA. By innovating constantly to bring the latest sunscreen technologies to the market, DSM hopes to make a significant contribution towards reducing the number of people living with preventable skin cancers.

1 “Most Americans don’t use sunscreen” ADD 2015
2 American Cancer Society

For more information

DSM North America

Hugh C. Welsh, President & General Counsel
+1 973 257 8208