Erik Lawrence Kreider - Comment

I urge FDA to investigate not only the sunscreen efficacy of spray sunscreens, but also the safety of such products from the fundamental use perspective and inherent risks associated with application of an aerosolized and volatile formula. I want to emphasize key risks associated with spray formulas: 1. Inhalation hazards of all formula chemicals - what safety data exists for this risk? 2. Vehicle chemistry exposure risks - many spray sunscreens utilize denatured alcohol as the primary vehicle, for example. What is the safety of transdermal exposure to this and other vehicle chemicals not used in cream formulas? 3. Primary user populations - a vast majority of spray sunscreens are used on young children, as parents view this application mode as 'convenient' because it is perceived to eliminate the need to rub the product on their squirmy children's skin. Children are often unable to know much less follow manufacturer's application instructions - how does this impact GRASE status? 4. Testing per OTC monograph - can the manufacturer demonstrate proper formula application density so as to reproduce the SPF testing protocol? FDA has already excluded powder forms; sprays have very similar issues associated with proper and reproducible formula application density.