It's hard to underestimate the importance of regularly wearing sunscreen to protect the skin from harmful ultraviolet rays. But recent reports suggest traces of benzene in sunscreens and a link to human health ailments have led to several voluntary recalls and consumer class litigation involving well-known brands. Concerns about whether certain sunscreens are actually "green," "sustainable" or "reef-friendly" have left consumers in the dark about what those terms mean, while leaving brands vulnerable to consumer class action litigation.
Here's what spas need to know about the most recent controversies surrounding sunscreen.
Defining Sunscreen and SPF
The National Institutes of Health's Cancer Institute defines sunscreen as a substance that helps protect the skin by reflecting, absorbing or scattering ultraviolet A (UVA) and ultraviolet B (UVB) radiation from the sun. Lotions, creams or gels that contain sunscreens can be used to help protect the skin from signs of premature aging and damage that may lead to skin cancer.
Mineral sunscreen uses physical blockers like titanium dioxide and zinc oxide, which sit on top of the skin to form a physical barrier between UV rays and the skin. Chemical sunscreens, which typically have a thinner consistency and blend into the skin or under cosmetics more easily than mineral sunscreens, protect from UV rays by absorbing them with chemical actives such as avobenzone, octocrylene and oxybenzone.
While mineral sunscreens may give the impression of being natural, both mineral and chemical contain synthetic ingredients.
Sun protection factor (SPF) is a measure of how well a sunscreen protects against sunburn.1 Sunburns are most often a result of exposure to UVB rays, which are also linked to certain types of skin cancer; UVA rays mostly cause skin aging and wrinkles.
The American Academy of Dermatology recommends an SPF of at least 30 for most people and most climates, while the U.S. Food & Drug Administration (FDA) recommends a broad spectrum sunscreen (which protects against both UVA and UVB rays) with SPF values of 15 or higher, reapplied at least every two hours or more often if exposed to water.
How Is Sunscreen Regulated?
The FDA considers sunscreen a nonprescription, or over-the-counter (OTC), drug. As opposed to cosmetics, which do not require FDA approval before they go on the market, sunscreens must either receive premarket approval by the FDA or confirm to the FDA's monograph, which specifies: which active ingredients are generally considered safe; the required labeling for sunscreen drug products; and what testifying procedures must be implemented for a sunscreen to be considered safe, effective and not misbranded.
Moisturizers and makeup marketed with sun protection claims may be regulated as both cosmetics and OTC drugs by the FDA and must comply with the requirements for both cosmetics and drugs.
In 2019, the FDA issued a proposed rule revising the requirements for sunscreen active ingredients, maximum SPF levels, broad spectrum requirements and forms (such as cream, lotion or spray), among other things.2 The proposed rule also included updates on how sunscreens are labeled to make it easier for consumers to identify key information.
In March 2020, the Coronavirus Aid, Relief, and Economic Security Act, also known as the CARES Act, updated the way FDA regulates sunscreen by requiring the FDA to issue a proposed order establishing what it means for sunscreens to be generally recognized as safe and effective.
On September 24, 2021, the FDA issued a deemed final order for sunscreens, which sets the current requirements for marketing OTC sunscreen products, as well as a proposed order to reflect the FDA's proposed requirements for OTC sunscreen products in the future.3,4
It's important to note that the FDA's proposed order has not, and will not, take effect until it is finalized by the FDA. However, it provides a good indication of how the FDA intends to regulate sunscreens in future.
Benzene Recalls and Litigation
Beginning in July 2021, a number of manufacturers issued a voluntary recall of certain sunscreen sprays after internal testing detected low levels of benzene in product samples. Benzene is a widely used industrial chemical naturally emitted by volcanoes and forest fires, and used to make other chemicals that are found in human-made products like plastics, lubricants, dyes and detergents.
While benzene is not an ingredient in sunscreen or otherwise used in manufacturing sunscreen, people claim trace amounts of benzene may be present as a result of its presence in the air due to other sources like tobacco smoke, gas stations, vehicle exhaust and industrial emissions, as well as its use in other chemicals.
Nevertheless, the recalls spurred dozens of benzene-related consumer class action lawsuits across the U.S. against sunscreen manufacturers. According to the complaints, plaintiffs claimed that companies harmed consumers by selling sunscreens that contained "dangerous concentrations of benzene," and that as a result, the sunscreens were improperly, deceptively or misleadingly labeled to suggest the products are healthy and safe. While many of these cases were dismissed in the early stages or settled, a number are still ongoing.
Reef-Safe Claims
In addition to benzene concerns, sunscreen manufacturers have faced legal claims for deceptive marketing by marketing sunscreens as "reef-safe," "marine-safe" or "reef-friendly."
As of January 1, 2021, Hawaii became the first state to ban the sale and distribution of nonprescription sunscreens made with oxybenzone and octinoxate after recent studies linked the ingredients to coral reef damage when sunscreen washes off skin and into the water.5 The passage of the law garnered significant attention to the effects of sunscreen on coral reefs and spurred numerous manufacturers to replace oxybenzone and octinoxate with other chemical UV light filters, then marketing those products as reef-safe or reef-friendly.
Significantly, the only two reef-safe active ingredients approved by the FDA are non-nanotized zinc oxide or titanium dioxide. (Non-nanotized means that the ingredient is 100 nanometers in diameter or more.)
As a result, several brands faced class action litigation accusing them of mislabeling sunscreen products as reef-friendly despite containing ingredients like avobenzone, homosalate, octisalate and/or octocrylene, which "are not safe for reefs," according to the plaintiffs. Plaintiffs have claimed that they were misled by the products' labeling and marketing, even where the ingredients were clearly disclosed, and stated that they were only aware of oxybenzone and octinoxate—the two ingredients banned in Hawaii. A number of these cases are still pending.
Takeaways for Spas
Brands should be aware of the potential for liability for promoting sunscreens as "clean," "natural," "chemical-free" or "reef-safe." While the risk of regulatory enforcement is comparatively low, government regulators will scrutinize "all or nothing" claims (e.g., "100% natural") or easily verifiable claims (e.g., "certified" reef-safe).
The risk for litigation, on the other hand, is high and potentially expensive. Wherever possible, spa and wellness businesses should avoid overbroad or all-or-nothing claims as to whether a sunscreen is natural or free from any substance. Sunscreens can contain trace concentrations of certain chemicals as a result of environmental exposure rather than intentional manufacturing, and even mineral sunscreens contain synthetic ingredients.
Remember that location matters. Hawaii became the first state to prohibit the sale of sunscreens containing oxybenzone and octinoxate, but other tourist havens such as the U.S. Virgin Islands, Aruba, ecological preserves in Mexico and certain Florida municipalities have proposed or are considering similar bans. Be aware of pending legislation, particularly in coastal or reef-adjacent communities.
Be cautious when describing products as reef- or marine-safe or friendly. These terms are not defined by the FDA, and their precise contours are subject to ongoing litigation. It's important to identify precisely what ingredients you're talking about excluding.
Stay up to date. FDA regulations and caselaw regarding sunscreen are in flux, and spas—particularly those advertising or selling private label sunscreens—should always remain aware of the current state of the law.
Make sure labeling claims will pass regulatory muster, especially with respect to ingredients that are likely to draw scrutiny. You also want to maintain consistency of claims and language with any marketers and influencers to ensure they are truthful, not misleading and adequately substantiated.
Footnotes
1. www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/sun-protection-factor-spf
5. https://oceanservice.noaa.gov/news/sunscreen-corals.html
Originally published in the June 2023 issue of WellSpa 360 magazine.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.
