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The FDA has unveiled a proposal for new sunscreen labels, with some products being removed from shelves. These changes will make it easier for consumers to find sunscreens that protect against UVA rays, which are responsible for skin damage without causing sunburn.
There are concerns regarding the safety of some sunscreen ingredients.
While many sunscreen ingredients are similar to those in non-SPF products like lotions, what sets sunscreen apart are the specific ingredients that either reflect or absorb UV rays. Currently, 16 ingredients are approved for this purpose and available in the market. The FDA has announced the following:
Only two ingredients (zinc oxide and titanium dioxide) are deemed “generally recognized as safe and effective.” These physical sunscreens reflect UV light away from the skin.
Two ingredients, PABA and trolamine salicylate, are no longer considered safe or effective and will be banned from sunscreens.
For the remaining 12 ingredients, the FDA has stated there is insufficient evidence to make a determination, and they are requesting more testing and data from manufacturers.
Earlier sunscreen regulations were based on the assumption that people would use only small amounts of low SPF products, with minimal absorption of ingredients into the skin. We now know that more is absorbed, making it necessary to conduct additional testing to ensure these levels remain safe.
Sunscreens need to improve their ability to block UVA rays.
Sunlight contains two main types of harmful rays: UVB, which causes the reddening effect known as sunburn, and UVA, which leads to long-term skin thickening and wrinkling. Although other types of rays exist, these are the most studied. UVA rays can penetrate windows, and you may be exposed to them even when not at risk for sunburn. Both types of rays contribute to the development of skin cancer.
The SPF rating on sunscreens only indicates protection against UVB rays. To determine if a sunscreen provides UVA protection, look for the label “broad spectrum.” Currently, there is no way to assess the exact strength of UVA protection (at least not on U.S. packaging). Your high SPF sunscreen might not offer much UVA defense, leaving you unaware of the risks as you stay in the sun.
Moving forward, the FDA requires all sunscreens with SPF 15 or higher to be labeled broad spectrum. These sunscreens must provide better UVA protection than they currently do, and the level of UVA defense must correspond to the overall UV protection. This means a sunscreen with SPF 50 will offer more protection from both UVA and UVB rays than one with SPF 15.
Formulations may be adjusted before the new regulations are fully enforced.
David Andrews, senior scientist at the Environmental Working Group, remarked in a press call today, “Today’s announcement will cause a sea change in how sunscreens are formulated.” (While we have some reservations about the EWG, they do keep a close eye on the industry.) Companies are likely already considering how to reformulate their products in anticipation of the rule changes, which could take anywhere from months to years to be implemented.
Here are some of the other proposed changes:
Combination sunscreen and bug repellent products may be banned due to differing labeling requirements for pesticides and personal care items, and their combined use has not been adequately tested.
Products such as sunscreen powders, wipes, and shampoos may be restricted unless their manufacturers conduct additional testing.
Sunscreens with SPF lower than 15 may be removed from the market. (Though this decision is not final, the FDA’s document questions the usefulness of these products.)
The FDA may limit high SPF values, with a suggested maximum of “60+” and a hard cap at 80. While some studies suggest higher SPFs could offer better protection, there is debate over whether the current SPF labeling system is reliable enough to make a significant difference for consumers.
