Many within the industry had been anxiously awaiting the FDA’s updated proposed requirements for sunscreens, which were to be issued in late 2019 via a new over-the-counter (OTC) sunscreen monograph system (it’s like a rulebook for ‘screens); however, those ingredient-upgrading rules never got inked. In their place, the CARES Act, which will offer guidance until a new monograph can be approved in September 2021, did three main things. First, it deemed the current U.S. chemical filters safe until further notice. That matters because certain studies have indicated that some chemical sunscreen actives can show up in blood and urine, and we simply need more studies to prove they’re completely safe to use.
Next, it allowed marketing for SPF 100-plus formulas. Protection factors over 60 have been called into question by some skin-care professionals since high SPFs like 75 and 100 can give wearers a false sense of sun safety, discouraging necessary reapplication and encouraging extended time in the sun. Plus, it’s important to note that SPF is an indicator of UVB protection, rather than UVA protection. While an SPF 100 might provide greater protection from getting burned, it could do little more than an SPF 30 in terms of guarding against UVA rays, which can age and damage the skin.
And finally, and perhaps most importantly, it laid the groundwork for American companies—many with an existing presence in other markets—to work with international chemical manufacturers to begin the process of introducing new sunscreen actives to the U.S. An array of international sunscreen filters have been touted by dermatologists and globetrotting skin-care enthusiasts as more efficacious, though most have never been legal Stateside. Will the CARES Act change that for American consumers in the near future? Based on the responses from industry experts, brands, and dermatologists, here’s what we’ve learned so far.
Understanding American-used SPF ingredients
Sunscreens in the U.S. are considered over-the-counter (OTC) drugs (rather than cosmetic products, like they are in many other countries), which means the FDA regulates what can and can’t be included in their formulas. The Personal Care Products Council, a trade organization within the cosmetics industry, was quick to release a statement regarding this legislation in March: “In the U.S., FDA regulates OTCs under a monograph system, which establishes various requirements for approval [of ingredients], including the safety and effectiveness of active ingredients in sunscreens. The legislation retains the regulations in the final monograph issued in 1999, which, among other things, confirms that active ingredients currently used in sunscreens on the market today are generally recognized as safe and effective (GRASE).”
Johnson & Johnson, already working with the BARDA, within the Department of Health and Human Services, in the effort to mass-produce a SARS-CoV-2 vaccine, spoke to Well+Good of changes that the CARES Act could have. “At Johnson & Johnson Consumer Health, consumer safety is our top priority. Our safety assurance process meets or exceeds industry and regulatory standards for personal care products, including sunscreens. We support FDA’s long history of regular review and declaration of safety for every sunscreen ingredient we use,” says Menas Kizoulis, scientific engagement director of global skin health for J&J. “Furthermore, we have long supported efforts to modernize OTC regulations. The changes made will create a more modern regulatory system that improves responsiveness to emerging science, enables more innovation, and allows us to better serve our consumers, patients, and healthcare professionals. We will continue to work collaboratively with FDA as they implement this new law.” For J&J, which owns Neutrogena, a best-selling adult sunscreen brand in the U.S., the opportunity to update sun-care formulas could prove significant.
Understanding the difference between safety standards in the U.S. and elsewhere in the world is essential to absorbing this news. According to Candace Noonan, Director of Education for DermaConcepts, the E.U. has approved more active sunscreen ingredients in recent years than the FDA, which hasn’t had sweeping updates in well over a decade. What’s more, in Korea and Japan, countries that are largely considered to have some of the best SPF filters in the world, sunscreens are regulated as cosmetics, so it’s much easier for manufacturers to bring new filters to the market, and keep formulas modern and effective.
Ultimately innovation from abroad will mean good things for Americans’ sun-care regimens. “[This action] will increase the list of chemical sunscreen options that can more comprehensively cover the broad UVA spectrum,” says Dallas-based board-certified dermatologist Flora Kim, MD, FAAD. “It is unfortunate that UVA protection has been largely de-emphasized here in the U.S. due to the outdated system of monographs at the FDA and the new drug approval process.”
Here in the U.S., chemical filters, such as oxybenzone, guard the skin against both UVA and UVB rays. However, it has largely fallen out of favor, likely in part due to widely publicized research showing it can be damaging the coral reefs. Today, commonly used chemical filters have to be cocktailed together, as they usually only guard against UVA or UVB. Meanwhile, physical sunscreens, such as zinc oxide and titanium dioxide, are considered inherently broad-spectrum. “Incorporating E.U. chemicals such as Tinosorb will add significantly improved UVA protection to the U.S. sunscreen market, which is currently lacking,” says Jessica Weiser, MD, FAAD, a board-certified dermatologist and assistant clinical professor of dermatology at Columbia University.
Adding new options could streamline formulas and give chemists a better array of actives. In practice, future sunscreens might be less likely to provoke acne, be gentler on sensitive skin, and even offer more cosmetically elegant (read: non-chalky) formulas—all of which will help to encourage SPF use. “The U.S. is limited to the filters listed in the monograph. This is something like 16 filters of which only eight are actually used in making sunscreens,” says cosmetic chemist Perry Romanowski. Elsewhere in the world, not only do other countries have broader filters to choose from, the process of incorporating new filters is often easier than it is Stateside. Says Romanowski of the potential to update formulas: “This allows [U.S. companies] to make better broad-spectrum sunscreens that have a more aesthetically appealing feel.”
The time constraints of change
Even with a green light, this will be a long trip for brands to incorporate new filters such as Tinosorb into new formulas. “New sunscreen formulations will not be likely in the U.S. prior to the FDA revision and amendment of the final sunscreen product monograph in September 2021, and will not [likely] become effective for an additional year, in September 2022,” says Dr. Weiser. And in the meantime, smaller, indie sun-care companies would benefit by doing their homework on the subject as international megabrands leap toward the review process.
“For too long, consumers have been restricted access to these leading-edge technologies that much of the rest of the world enjoys. The OTC Reform Act provisions included in the CARES Act are intended to offer an expedited route of FDA submission and review processes for new sunscreen ingredients currently allowed for use in international regions,” says Rick Woodin, chief scientist of ZO Skin Health, Inc. “In conjunction, the CARES Act stipulates that an 18-month market exclusivity period may be granted to a sponsor for an OTC sunscreen drug product that is approved by FDA that contains an active ingredient not previously incorporated in a sunscreen Over-the-Counter drug product in the U.S.” This means that companies that have read the fine print now know that whichever brand gets approval on a specific ingredient, such as Tinsorb, first can dominate sales.
What it means for the future
“Once these new ingredients are approved and incorporated into sunscreen, Americans will finally have a truer sense of active ingredient safety, better UVA protection, and more transparent labeling of sunscreen packaging,” says Dr. Weiser. In her opinion, this combo will lead to higher quality sun protection with fewer health concerns.
Companies like COOLA will actively be looking at any new potential ingredients, their efficacy, and possible inclusion in future formulas. Founder Chris Birchby notes that the company formulates all products with 70 percent organic ingredients and only a portion use chemical actives. “It’s to be determined how much this potential change will affect our formulas,” says Birchby. “Mineral active formulas will not be affected, as they use only zinc oxide and/or titanium dioxide as actives, and those ingredients are globally approved.”
Despite its stealth arrival, brands seem hopeful that this news will continue to push the industry forward. “We’ve been watching the available actives in Europe, Australia, and Japan for years, and have been pushing for use of the same actives here in the U.S.,” says Sun Bum founder Tom Rinks. “If it results in bringing new, safe actives to America, we will be thrilled, along with, I’m sure, every sunscreen company in the U.S.,” Rinks continues. “What this ultimately means is more clean ingredients for manufacturers like us to use to help protect our families, friends, and community from the dangers of the sun. When you create products to protect the ones you love, this news is about as good as it gets.”
Correction: Johnson&Johnson is working with BARDA, which is within the Department of Health and Human Services, not the FDA as previously stated. We have also expanded the statement from J&J to provide additional context.
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