MYTH: Oxybenzone is a hormone disruptor.
FACT: Unsubstantiated concerns by some groups such as the Environmental Working Group allege that oxybenzone may be capable of altering/disrupting normal hormonal (endocrine) balance. Specifically, these groups claim that oxybenzone has estrogenic activity, or the ability to exhibit properties similar to the hormone estrogen. No available and reliable scientific data to date indicate that oxybenzone has estrogenic effects that could potentially affect human health. In fact, a 2011 study estimated that it would take up to 277 years of daily application of a sunscreen containing 6% oxybenzone to attain a comparable level of exposure in humans as was used in laboratory studies that demonstrated potential estrogenic potential.
Another study in 2004 reported that when oxybenzone was repeatedly applied to the entire body of human volunteers, no biologically significant alterations in reproductive hormones (testosterone, follicle-stimulating hormone, luteinizing hormone or estradiol) were detectable.
Furthermore, a 2021 review of the safety of the sunscreen ingredient benzophenone-3 (BP-3; oxybenzone) by the EU SCCS concluded that the currently available evidence for endocrine disrupting properties of BP-3 is inconclusive and equivocal at best.
MYTH: Oxybenzone causes coral bleaching.
FACT: The threat to the world’s coral reefs is a serious concern. According to the U.S. National Oceanic and Atmospheric Administration’s (NOAA) Coral Reef Conservation Program, coral reefs are impacted by an increasing array of hazards and atmospheric carbon dioxide levels that have contributed to global warming and ocean acidification. Ocean acidification and global warming are the major causes of coral bleaching (NOAA 2011), not sunscreens. Other cited causes of coral bleaching are over-fishing and factors that impact water quality, such as nutrient pollution from land (Hughes et al., 2007; Wiedenmann et al., 2013). However, a study published in Nature concluded that global warming continues to cause widespread coral bleaching even when other factors have been locally addressed (Hughes et al., 2017).
In August 2022, the National Academy of Sciences (NAS) issued a thorough and comprehensive review of the state of the science on the use of currently marketed sunscreen ingredients, their environmental impact on aquatic environments, and the potential public health implications associated with changes in sunscreen use. An ad hoc committee of the NAS called upon the EPA to conduct an environmental risk assessment (ERA) of sunscreen UV filters to characterize possible risks to aquatic ecosystems and the species that live within them, including coral. The report identified information gaps and research priorities necessary to inform a tiered approach to the ERA:
- There is currently insufficient relevant and reliable scientific data to conduct realistic ERAs and there is not enough scientific data to support sunscreen ingredient bans. Policymakers, regulators and legislators should not make any decisions that impact consumers’ access to FDA-approved sunscreen UV filters until the scientific community reaches an informed consensus.
- Despite some recognized knowledge gaps, NAS acknowledges that if consumers reduced their use of currently marketed sunscreens because of regulatory restrictions or perceived environmental risks, there could be significant potential adverse public health impacts of increased UV-induced skin cancers. Medical experts and regulatory authorities worldwide agree that sunscreens play a critical role in a safe-sun regimen and nothing in the report changes that recommendation.
- The environmental and public health data gaps are complex and will require close cooperation among governmental agencies, sunscreen manufacturers and UV filter manufacturers to conduct the needed research.
Despite a significant body of literature linking other factors to coral bleaching, two studies have attempted to break with scientific consensus and link coral bleaching to sunscreen ingredients, such as oxybenzone (Danovaro et al., 2008; Downs et al., 2016). Leading environmental scientists have highlighted a number of serious problems with the studies’ test designs and the conclusions they reached. Major concerns include:
- Studies were conducted in laboratories under simulated environmental conditions that do not adequately reflect the complexities of the natural marine environment. For example, in the natural environment coral thrives as part of elaborate ecosystems. Removing coral from its natural habitat will have serious impacts on the animal’s health and its ability to survive.
- Serious questions have been raised over the validity of the analytical and toxicological findings in these studies, as well as the test systems that were used.
- The oxybenzone levels reported by these laboratory studies have not been detected in other studies conducted in the natural marine environment.
- The findings of the studies have not been reproduced by other researchers – a key process when establishing scientific consensus.
Sunscreens are regulated by the FDA as non-prescription, over-the-counter (OTC) drugs through a monograph system, which establishes various requirements for the product to be sold in the U.S. A monograph specifies the types of ingredients, dosage forms, testing methods, labeling requirements, and other related details for a product category, such as sunscreens. If a manufacturer follows the sunscreen monograph, its sunscreen products do not require separate FDA pre-approval before they can be sold in the U.S.
In February 2019, the FDA published a proposed rule intended to put into effect a tentative final monograph (TFM) for non-prescription, OTC sunscreen products. The rule described the conditions under which OTC sunscreen products are generally recognized as safe and effective (GRASE) and not misbranded. As one of FDA’s proposed actions, the Agency requested additional data on certain currently marketed active ingredients, including oxybenzone. The subsequent passage of the “CARES Act” in March 2020 amended the monograph framework for sunscreens, changing it from traditional notice-and-comment rulemaking to an Administrative Order process.
Importantly, sunscreens made with these ingredients are not considered unsafe by the FDA and will remain on the market to be used as part of consumers’ sun-safe practices while more data are collected. These filters are approved around the globe and have been used in formulations in the U.S. for decades.
As part of the proposed Administrative Order announced on Sept. 27, 2021, mirroring the 2019 TFM, the FDA reiterated its request for additional data and stated: “This proposed order does not represent a conclusion by the FDA that the sunscreen active ingredients proposed as having insufficient data are unsafe for use in sunscreens. Rather, we are requesting additional information on these ingredients so that we can evaluate their GRASE status in light of changed conditions, including substantially increased sunscreen usage and evolving information about the potential risks associated with these products since they were originally evaluated. Sun safety is important for everyone and all skin tones, and consumers can reduce risks from sun exposure with continued use of sun protection measures, including sunscreen.”
The Personal Care Products Council (PCPC) and its member companies that manufacture sunscreen products have been working closely with the FDA to develop data that will address the knowledge gaps that the FDA identified.
Oxybenzone (benzophenone-3) is also approved by the FDA as indirect food additive for use as basic component of single and repeated use food contact surfaces.
Expert Panel for Cosmetic Ingredient Safety
The safety of benzophenones and related ingredients, including oxybenzone, was first assessed by the Expert Panel for Cosmetic Ingredient Safety (formerly the Cosmetic Ingredient Review Expert Panel) in 1983. The Expert Panel conducted a review of the available scientific literature and concluded that oxybenzone and related benzophenones -1, -4, -5, -9 and -11 were safe for their current and intended use in cosmetics and personal care products.
In 2005, the Expert Panel again reviewed these ingredients and concluded that the original safety assessment remained scientifically valid.
In 2021, the Expert Panel reopened the safety assessment of benzophenone cosmetic ingredients. The assessment included review of the results of the U.S. National Toxicology Program (NTP) oxybenzone carcinogenicity study. Based on these results, the Expert Panel did not express any concern over the carcinogenic potential of benzophenones as used in cosmetic products. It concluded that all 11 of the benzophenones (including oxybenzone) are safe in the present practices of use and concentration.
Oxybenzone is currently listed in Annex VI, entry 4 of the Cosmetics Regulation of the European Union and may be used at a maximum concentration of 6%, in sunscreen products and up to 0.5% to protect products from deterioration due to exposure to UV light.
The EU’s Scientific Committee on Consumer Safety (SCCS) was asked to review new scientific data on benzophenone-3 (BP-3) and issued an opinion on its safety in June 2021. On the basis of the safety assessment of BP-3,, the SCCS concluded that the use of BP-3 as a UV filter up to a maximum concentration of 6% in face cream, hand cream and lipsticks is safe for the consumers. It also concluded that BP-3 is safe for use as a UV filter up to a maximum concentration of 2.2% in sunscreen body creams, propellant sprays and pump sprays provided that there is no additional use in the same formulation for protecting the cosmetic formulation from deterioration due to exposure to UV light. When BP-3 is also used at 0.5% in the same formulation, the levels of BP-3 used as UV filter should not exceed 1.7% in body creams, propellant sprays and pump sprays.
Finally, the SCCS concluded that the use of BP-3 up to 0.5% in cosmetic products to protect the cosmetic formulation from deterioration due to exposure to UV light is safe for the consumers.
Until the EU changes to the Annex VI regulation of UV filters based upon the 2021 SCCS opinion, oxybenzone may continue to be used as a sunscreen ingredient in sunscreen formulations in the EU at a maximum concentration of 6%.