AkzoNobel Surface Chemistry, LLC - Comment

September 12, 2011 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm. 1061Rockville, MD 20852 RE: 21CFR Part 352; Docket No. FDA-1978-N-0018; formally Docket No. 1978N-0038 To Whom It May Concern, In response to the Food and Drug Administration’s (FDA) request, the Global Personal Care sub-business of AkzoNobel Surface Chemistry, LLC (ANSC) welcomes the opportunity to submit data on over-the-counter (OTC) sunscreen products. This data is to be used to resolve specific questions about both effectiveness and safety of sunscreen spray products. Ultimately, we would like this data to be used in establishing the monograph conditions, including dosage forms for sunscreens that are generally recognized as safe and effective (GRASE). In summary, this submission contains data that demonstrate spray dosage forms are not sufficiently different from a sunscreen lotion, an eligible dosage form identified by the FDA during the development of the sunscreen monograph. In a test panel study, it was concluded that the sunscreen spray product was actually applied in a greater concentration that the sunscreen lotion product (see details below). Also, within this submission, there is data demonstrating that there is no significant difference between the SPF values of sunscreen sprays and sunscreen lotions. Finally, we are submitting a summary of an inhalation toxicology study, which was performed on our Dermacryl 79, a film forming product used in over 90% of marketed sunscreen spray forms. Thank you for allowing this opportunity to help in the development of the sunscreen monograph. If you would like any additional information, please feel free to contact us. Sincerely, Damani K. Parran PhD DABT