FDA Issues Proposed Rule to Make Sunscreens Safer

By Kristin J. Kelley

Edited by William E. Chavey, MD, MS

The FDA proposed new rules on Thursday for over-the-counter sunscreen sold in the U.S.

Under the proposed rule issued by the agency, only two out of sixteen currently marketed active ingredients used in sunscreens — zinc oxide and titanium dioxide — are "generally recognized as safe and effective" (GRASE). Two ingredients — PABA and trolamine salicylate — are not GRASE because of safety issues, and there is insufficient data on the remaining twelve.

The proposed rule also includes the following recommendations:

• The maximum proposed SPF value on sunscreen labels should be raised from SPF 50+ to 60+.

• Similar to other over-the-counter drug labels, sunscreen labels should list the active ingredient on the front of the package so consumers can identify them easier. Additionally, if a product hasn't been proven to help prevent skin cancer, a notification should appear on the front.

• Products that combine sunscreen with insect repellent are not GRASE.