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 20 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.
Parsol Shield (bemotrizinol or BEMT) is a photostable broad-spectrum filter that efficiently provides UVB and UVA protection even at low concentrations, according to DSM. It is easy to use and compatible with both organic and inorganic UV filters. At present, it is not available in the US 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 US 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.