It's not often that a government-run agency issues a ruling that could affect the way millions of customers perceive a product and cause millions of dollars in packaging charges to suppliers. That's what sun care manufacturers are facing over the next 20 months due to the Food and Drug Administration's final monograph on sunscreens.
The monograph, which was issued this past May, has generated hundreds of comments from suppliers who are arguing that many of the repackaging, relabeling and reformulation rules to be required are all for naught. Naturally, manufacturers are not looking forward to complying with a ruling that could cost a total of $35 million-plus. But their main beef questions how exactly the monograph will benefit consumers. What gives this rallying cry an edge is the support manufacturers are receiving from consumer groups and organizations, including the American Academy of Dermatology and the Cosmetic, Toiletry and Fragrance Association, as well as the medical community.
Among the changes required by the new monograph is a cap on sun protection factors to be limited to 30, or at the most, 30+. Warnings will need to be put onto bottles of sun tanning lotions that do not contain sunscreen. Also, cosmetics and self tanners containing SPFs will be considered OTC drugs, in many cases requiring a change in packaging and labeling.
Estimates say there are approximately 2,800 sunscreen products and about 12,000 individual SKUs that will be affected by the ruling. Overall, the FDA believes approximately $35 million will be spent due to the new monograph. The effect on consumers, though, cannot be put into monetary figures. According to the AAD, consumers currently do not apply the correct amounts of sunscreen to benefit efficiently from the SPF value on bottles.
In turn, limiting SPF values to 30 may result in a real SPF value of 15 for a consumer who does not put on the recommended one-ounce amount. "While sunscreens with an SPF of 30 can provide significant protection from harmful ultraviolet (UV) exposure, dermatologists understand that sunscreen application is usually less than that used under the watchful eye of researchers," said an AAD spokesperson.
