FDA officials admit they have chosen to allocate their limited resources to approving OTC drugs that pose more imminent health risks. But growing public awareness of potentially excessive sun exposure may generate pressure for final rules on how much protection can be claimed on product labels. Still to be worked out are how claims should be worded and how to harmonize U.S. rules with those of other countries.
Consumers may not realize that there are no official government standards for sunscreen protection and its labeling. Proposed rules issued by FDA, which treats sunscreen as an OTC product, have become de facto guidelines adopted by sunscreen manufacturers, with compliance high.