Under the proposed regulation, manufacturers of over-the-counter sunscreen products would be required to test their products for UVA protection using a specific test to measure the product's ability to reduce the amount of UVA light that passes through it and a test that measures the product's ability to prevent tanning. The UVA rating would be based on the lowest of the two test results. If a manufacturer does not perform the tests, or the tests find no UVA protection, then the label will have to state “no UVA protection.”
UVB protection will continue to be based on the SPF rating, but the FDA has proposed changes to the SPF testing methods to make the results more accurate and reproducible.
Under the regulation, companies would also be able to combine avobenzone with either zinc oxide or ensulizole, which Dr. Holman said would increase the number of sunscreen products available. The agency would consider revising the upper SPF limit allowed in the packages if data become available that support accurate testing of sunscreens with an SPF greater than 50.
During the comment period, the FDA is requesting comments and more information about the safety of sunscreen ingredients that use nanotechnology, because of the potential risk of nanoparticle ingredients penetrating consumers' skin, and on novel sunscreen formulations, such as foams, sprays, and towelettes. The proposal does not apply to insect repellant products combined with sunscreens, but it does apply to cosmetic products that contain sunscreen and SPF claims.
The FDA is accepting written comment on the proposal for 90 days following the announcement, until Nov. 26.
More information, including how to makea written comment, is available online at www.fda.gov/cder/drug/infopage/sunscreen/default.htm.