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In June of 2011, the U.S. Food and Drug Administration (FDA) published a Code of Federal Regulations (CFR) on sunscreen1 that states: The record does not currently contain sufficient data to indicate that there is additional clinical benefit above SPF 50. It went on to call for data demonstrating a clinical benefit for products having an SPF higher than 50. Also in June of 2011, the FDA published a request for data and information regarding dosage forms,2 stating that spray forms for sun care products are not approved but are eligible to be approved if adequate studies are submitted showing their effectiveness. The FDA asked for information concerning:
1. How much spray consumers use and what amounts are transferred to skin;
2. How uniform the coverage is;
3. How often users reapply;
4. Whether users follow directions to rub in the product;
5. How rubbing changes effectiveness;
6. How protection levels in actual use compare to laboratory conditions; and
7. Whether testing procedures should be modified to address sprays.
In response to the questions about the clinical benefits of products with SPFs higher than 50, the author’s company submitted test data to the FDA showing that a group of four commercial products with SPFs between 70 and 85 protected better than a group of four commercial products with SPFs from 50 to 55 in outdoor tests.3 Further, some of the questions concerning sprays were answered. During the comment period, Akzo Nobel submitted a comment documenting that users applied more spray than lotion, that uniformity was the same when sprayed or rubbed, and that protection when sprayed or rubbed was equal.4
Energizer Personal Care also submitted data showing that sprays provided uniform protection, spray users apply more frequently than lotion users, and the number of users that only sprayed were practically equal to the number of users that sprayed and rubbed. Further, the company submitted test data showing that spraying without rubbing offered equal protection to spraying and rubbing.5
Some of the data presented5 was based on a consumer use study of 387 subjects, who filled out a one-week diary of their habits. However, taking it a step further, the author’s company sent team members out to walk a busy beach and question users directly, to find out what SPFs and dosage forms were being used and how sprays were applied when used. Their findings are presented here.
This is only an excerpt of the full article that appeared in Cosmetics & Toiletries, but you can purchase the full-text version.