Regulations and Updates Shaping the Future of SPF
A new proposal from the U.S. Food and Drug Administration (FDA); regional bans on sunscreen actives; added ingredients that enhance SPF formulations. There’s a lot happening in the realm of sunblock, and it’s important to stay on top of the latest news to ensure your clients are properly protecting the skin you’ve spent so much time perfecting. That’s why we put together this primer on the latest mandates, regulations and updates, as well as how they may affect the future of these essential products.
New FDA Proposals
On February 21, 2019, the FDA released a proposed rule aimed at increasing the safety and efficacy of over-the-counter (OTC) sunscreens, and to help the agency finalize regulations as required by the Sunscreen Innovation Act of 2011. Public comments were to be submitted by the end of May. “The FDA made some major recommendations,” says Robert Manzo, cosmetic chemist and founder of Skinprint, a manufacturer of physician-dispensed skin care and sunscreens. Here are the primary issues addressed.
Sunscreen Actives: There are 16 UV protectant actives approved for use in the U.S. The FDA made—for the first time—a distinction between ingredients it considers “generally recognized as safe and effective” (GRASE) and those it doesn’t. “Zinc oxide and titanium dioxide are the only actives considered GRASE for use in sunscreens. The FDA is saying that two other ingredients, PABA and trolamine salicylate, aren’t GRASE and aren’t to be used,” says Manzo.
He clarifies that this doesn’t mean other ingredients aren’t safe and effective, nor that PABA and trolamine are toxic or carcinogenic. “In terms of the other 12 actives, which are organic—or chemical—versus physical, the FDA wanted to look at them in more detail and asked manufacturers to provide more information on effectiveness and dosing,” explains Manzo. “Regarding the two non-GRASE ingredients, the concern isn’t that they’re toxic; it’s that they give rise to adverse effects when tested on the skin, including inflammation, swelling and redness.”
Proper Dosing: The FDA also asked manufacturers to provide input on the percentage of actives used in their formulations. “In some cases, the FDA has specified minimum and maximum levels for active ingredients,” says Manzo, referring to the sunscreen monograph, which is the agency’s standard of ingredients that covers dosage, labeling, indications, etc. “For the rest, you tend to see varying levels of actives from product to product. I’m sure that within three to five years the FDA will create narrow dosage ranges for organic ingredients based on the feedback it receives.”
Powders Vs. Liquids: The proposed rule differentiated between liquid sunscreens—including sprays, oils, lotions, creams, gels, butters, pastes, ointments and sticks—and powder sunscreens. Powders may be eligible for the monograph, but first the FDA wanted more data. Additionally, wipes, towelettes, body washes and shampoos that claim to offer UV protection may be categorized as new drugs, because the FDA doesn’t have enough data for their inclusion in the monograph. “The FDA is saying that you can use these actives in sprays, lotions and gels because we know absorption rates for liquids. But when you put them into powders, there may be issues in terms of application and SPF protection, so we need more information,” says Manzo.
Raising SPF Limits: The sunscreen monograph of 2011 limited SPF labeling claims to SPF 50+. This year, the FDA proposed raising the maximum value to SPF 60+. “A product with SPF 30 blocks about 95 percent of UV rays. For SPF 100, it’s about 99 percent,” says Larry MacPhee, general manager of physician-dispensed sunscreen and skincare manufacturer EltaMD.
The initial cap of SPF 50 led to pushback from both industry and consumer groups, causing the FDA to propose the increase. “This is a big deal because it allows manufacturers to create more complex formulations and offer a diverse range of products. And it was due, in part, to consumer calls,” says Manzo. “Now the FDA has said that yes, there is enough of a difference between SPF 50 and SPF 60 to have a real effect on skin health.”
Broad Spectrum Requirements: As of press time the proposed rule is still pending, but if it’s finalized, all sunscreens with an SPF 15 value or higher must provide broad spectrum (UVA and UVB) protection, and the level of UVA protection must increase as the SPF level increases.
Testing Consistency: Currently, manufacturers use in-house and/or third-party labs to assess the safety and efficacy of their sunscreen products. So, the proposed FDA rule sought feedback to create more consistent testing protocols and record-keeping requirements to help the agency assess industry compliance with regulations.
Visible Light Reduction
In recent years, sunscreen formulations have evolved to offer new protections against visible light and infrared radiation (IR). “Studies suggest that blue light—visible light from computer screens—and IR can cause skin damage,” says MacPhee. He notes that IR in particular upregulates the production of MMP1s, enzymes that can degrade the extracellular matrix. “The skin reacts to exposure as if it’s being damaged, which increases the presence of free radicals,” he says.
Ingredients touted as defending skin from blue light and IR are typically antioxidants, such as CoQ10 and vitamin E. “To block IR you need to wear something opaque, such as clothing or a hat,” says MacPhee. “But adding antioxidants to sunscreen can help offset the production of free radicals. We can also use enzymes that specifically downregulate MMP1s, as well as peptides to help skin healing.”
When it comes to ensuring clients use their sun protection products regularly, cosmetically appealing formulas are key. “A big issue with many organic sunscreens is that they don’t feel very good on the skin,” says Manzo. “You need anywhere from 15 to 30 percent active ingredients to provide optimal protection.” Because these organic/chemical actives tend to be oil based, users often don’t apply the recommended amount or reapply as directed. Conversely, physical sunscreens can be drying to the skin. “Titanium and zinc together produce a very nice combination of UVA and UVB protection,” says MacPhee. “The dilemma is that they’re both white powders, so making a cosmetically elegant physical sunscreen is difficult—people won’t use it if it’s greasy or turns their skin white.”
To combat this, manufacturers are mixing chemical and physical blocks, and adding actives that both feel good and offer more benefits. “High SPF level zinc oxide and titanium dioxide products, if they aren’t coated properly, pull moisture from the stratum corneum,” says Manzo. “We can offset that with sodium hyaluronate and hyaluronic acid. The skin doesn’t dry out as much, and it feels better for the consumer.” Cyclomethicones, synthetic molecules derived from silicon and oxygen that create a smooth texture, are often added to make products more pleasing to the touch; if it feels nice, people are more likely to use it as recommended, notes Manzo.
As always, education is most important for guiding clients to the right products and making sure they use them correctly. “Help them understand that if they aren’t reapplying within an hour and a half, they’re exposing themselves to skin cancer risks,” says Manzo. “Don’t scare them, but do educate them.” To that end, the American Academy of Dermatology (AAD) developed a “Say Yes to Sun Protection” infographic that can be downloaded at aad.org. Print it out for employees and guests alike so they can learn about different types of sunscreen and how they can best protect their skin—and remind them that the right sun protection is necessary for a healthy complexion.
In 2018, Hawaii banned the sale of sunscreens containing oxybenzone and octinoxate due to concerns that they damage delicate coral reefs; Key West, Florida, followed suit in January 2019. Although some in the sunscreen industry dispute the risk, as the available research is inconclusive, the new legislation is affecting sunscreen formulation—namely the reworking of products to include actives in place of octinoxate. “Our goal is to provide sun protection that people are comfortable with and have confidence using,” says Larry MacPhee, general manager of physician-dispensed sunscreen and skincare manufacturer EltaMD, who believes we’ll see more of these regulations in the future. “I wouldn’t be surprised if other oceanfront states adopt this kind of regulatory requirement, so formulators are getting ready by creating other options.”
–by Inga Hansen
This story first appeared in the June issue of Dayspa magazine. To receive the magazine, click here to subscribe.