Magazine article Drug Topics

FDA's Proposed Rule for OTC Sunscreens Includes UVA Ratings

Magazine article Drug Topics

FDA's Proposed Rule for OTC Sunscreens Includes UVA Ratings

Article excerpt

The Food & Drug Administration has issued a proposed rule that sets sweeping new standards for formulating, testing, and labeling over-the-counter sunscreen products with ultraviolet A (UVA) and B (UVB) protection. The rule appears in the Aug. 27 Federal Register.

Here are the highlights of the proposed changes:

* UVA protection will be clearly identified on the front of sunscreen products by the term UVA followed by one, two, three, or four stars as well as the corresponding terms low, medium, high, or highest.

The rating will appear next to the sun protection factor, or SPF, value. If testing determines a product does not provide any UVA protection or does not test for UVA protection, the product must be clearly labeled, "no UVA protection" near the SPF value.

* The UVA rating will be determined by conducting two tests: a laboratory test and a test on people. The rating will be the lower rating of the two tests. For example, if a product rates low on one test and medium on another test, the product will be labeled as low, or one star.

* The rule proposes to require a warning on sunscreens informing consumers that UV exposure increases the risk of skin cancer, premature skin aging, and other skin damage. The ruling cautions consumers to decrease UV exposure not only by wearing a sunscreen, but also by limiting sun exposure and wearing UV protective clothing and hats.

* The regulation includes directions to reapply sunscreens at least every two hours and to apply and reapply as directed to avoid lowering protection.

* The regulation revises existing SPF labeling. The front label of a sunscreen will include the term UVB next to the term SPF to inform consumers that SPF values reflect UVB sunburn protection. Additionally, the term low, medium, high, or highest must appear alongside the SPF values, similar to the new UVA rating.

* The new regulation proposes changes to the test used to determine SPF value. The changes include a new SPF 15 test standard and revised solar simulator specifications.

Other changes

The FDA also is amending its existing 1999 rule to increase the SPF range that products can sport from SPF 30+ to SPF 50+. Previously, the agency had recognized SPF values up to 30+. Under the proposed amendment, the range would be SPF 2 to SPF 50+.

* The rule allows the active ingredient avobenzone to be combined with zinc oxide or ensulizole (a UVB blocker). …

Search by... Author
Show... All Results Primary Sources Peer-reviewed


An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.