FDA Looks Into New Sunscreen Regulations and Guidelines

The United States Food and Drug Administration has finally issued a long-awaited update to sunscreen guidelines.  The focus of this change is to actually strengthen regulations for over-the-counter sunscreens. 

If you were not aware, only 2 of the 16 currently most common chemical ingredients in all over-the-counter sunscreens are considered to be safe. These are zinc oxide and titanium oxide. In addition, the FDA says that PAGA and trolamine salicylate are not permitted for use in OTC (non-prescription) sunscreen products.  Finally, the agency confides it is requesting that the industry collect additional data on the remaining 12 ingredients. 

FDA Commissioner Scott Gottlieb, MD, comments, “Today’s action is an important step in the FDA’s effort to take into account modern science to assure the safety and effectiveness of sunscreens.  The proposed rule that we issued today would update regulatory requirements for most sunscreen products in the United States, to better ensure consumers have access to safe and effective sun care option in line with the latest science.”

Essentially, the focus is to establish a standard set of conditions under which some sunscreen (drug) products can be sold over the counter without FDA approved marketing.  For example, Gottlieb notes, some of the most essential requirements for preventative tools—like sunscreen—have not been updated in several decades.  

Furthermore, Gottlieb attests, “Broad spectrum sunscreens with SPF values of at least 15 are critical to the arsenal of tools for preventing skin cancer and protecting the skin from damage caused by the sun’s rays, yet some of the essential requirements for these preventive tools haven’t been updated in decades.”

Sweeping new regulations would bring about a transformative shift into how sunscreens are formulated, which could make them not only more effective but safer as well.  The proposal includes several changes, including raising the maximum sun protection factor—you might know this as SPF—on sunscreen labels. It would raise the maximum protection available from 50+ to 60+.  SPF is the term for the mechanism which measures the extent of protection that a sunscreen product can offer against ultraviolet radiation in the sun’s rays, which, in theory, reduces risk for developing skin cancer.  SPF 15 blocks about 93 percent of UVB rays; SPF 30 blocs about 97 percent, and SPF 50 blocks about 98 percent.  All this in mind, the FDA encourages that everyone should continue using sunscreens and other skin protectants, even as the rulemaking process continues.