Sunscreens; i.e., products that claim sun protection factor (SPF), are regulated as nonprescription or over the counter (OTC) drugs in the US. However, that is not the case in most other countries, where they are regulated as cosmetic products. Because they are drugs in the US, the active ingredients used in sunscreen products must be proven safe for human use per the safety and efficacy requirements of the Food and Drug Administration’s (FDA) OTC Monograph for sunscreen drug products.¹ Furthermore, as drugs, they may also be subject to an evaluation of their potential environmental effects as seen in FDA’s announcement of May 13, 2021, indicating its intent to Prepare an Environmental Impact Statement (EIS) for oxybenzone and octinoxate due to questions raised about the extent to which these two sunscreen active ingredients may affect coral and/or coral reefs.^2,3

You would think that after decades of extensive use neither human safety nor environmental safety would threaten the availability and use of consumer SPF products. But you’d be wrong! If the current sunscreen actives that have not already been determined by FDA to be generally regarded as safe and effective (GRASE) are not found to be safe for human use through additional studies, FDA will ban them. If their environmental impact is found to be unfavorable and no reasonable alternatives are found, they may be restricted or prohibited from use in sunscreen products. Moreover, other regulatory agencies, such as the US Environmental Protection Agency (EPA), non-government organizations, legislators, litigators and public opinion will make it impossible to commercialize sunscreen products containing such ingredients. Any such outcome, of course, will have global impact.

Human Health Front

Regarding the attack on human health, to put it into perspective, one must start with the development of the sunscreen OTC monograph. In 1978, FDA formally started regulating sunscreens under a draft monograph that was issued under an advanced notice of proposed rulemaking.⁴

For more than 40 years the sunscreen monograph was revised several times but not finalized, although in 1999 FDA did issue a final monograph that was partially stayed in 2001,⁵ and then in 2011 issued a final labeling effectiveness testing rule, which is still in effect.⁶

Most recently, in February 2019, FDA published a proposed “Tentative Final Monograph” (TFM) updating the requirements for sunscreen products,⁷ but following the passage of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), on September 24, 2021, FDA posted Final Administrative Order (OTC000006) Over-the-Counter Monograph M020 for Sunscreen Drug Products that was later amended as proposed (PO) and is essentially the same as the 2019 TFM but contains new provisions for regulating OTC drug products as required by the CARES Act.^8,9 How FDA went from a monograph process to an “administrative order” (AO) process is not the aim of this article. In a nutshell, the 2021 PO establishes new conditions under which nonprescription sunscreen drug product active ingredients will be determined to be GRASE and when finalized will replace the deemed order (i.e., 1999 Stayed Final Monograph) and 2011 final labeling and effectiveness rule. The 2021 PO also includes revisions and updates related to maximum sun protection factor (SPF) values, active ingredients, broad spectrum requirements, dosage forms and product labeling. But more importantly, it asks for new data on human safety for what was previously known as Category GRASE III (insufficient data available to permit final classification) active ingredients and dosage forms.

The PO organized sunscreen active ingredients into three categories or groups related to their GRASE (Generally Recognized As Safe and Effective) status. Only two ingredients are classified as GRASE Category I (safe and effective). These include zinc oxide and titanium dioxide, that are the only two mineral or inorganic actives, on the list of 16 permitted active ingredients in the sunscreen monograph. As per FDA’s assessment, these are considered safe for human use. Two actives, aminobenzoic acid (PABA) and trolamine salicylate are GRASE category II (not GRASE). These are therefore prohibited for use. The third group, GRASE Category III (insufficient data available to determine if GRASE), is the largest group and composed of what is referred to as the “chemical” or “organic” sunscreens. The 12 SS in this group are cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone and avobenzone. These require additional safety data for FDA to move them into GRASE Category I.

According to FDA, the PO does not represent a conclusion that the sunscreen active ingredients proposed as having insufficient data are unsafe for use in sunscreens. Rather, FDA is requesting additional information so that it can evaluate their GRASE status in light of changed conditions, including what it calls substantially increased sunscreen usage and evolving information about the potential risks associated with these products since they were originally evaluated.¹⁰

FDA also has stated that “given the recognized public health benefits of sunscreen use, consumers should continue to use sunscreen in conjunction with other sun-protection measures.”¹¹ As such, they see no reason to date to prohibit them for use in sunscreen products.

The studies FDA requested to determine GRASE status of Category III active ingredients are clinical and non-clinical in nature with some other in vitro penetration tests and additional tests and data. The human clinical studies needed include dermal irritation and sensitization as well as dermal phototoxicity. Human absorption or pharmacokinetic (PK) studies such as maximum usage trials (a.k.a., MUsT studies) are also required. Regarding miscellaneous tests, pediatric data, post-marketing safety analysis, and testing of some representative marketed products with focus on dosage forms and non-active ingredients may be required.

The most problematic of all are the non-clinical studies. They are problematic in terms of using animals, cost and time. The industry hopes to convince FDA to accept weight-of-evidence and new alternative methods (NAMs) instead of animal studies. The timeline to fully meet the testing requirements proposed by the FDA is complex and will take many years. The approximate cost for each individual active could be more than $12 million. In addition, if the MUsT studies required show a systemic absorption of actives greater than 0.5ng/ml, the following studies may be needed: toxicokinetics, systemic and dermal carcinogenicity, developmental and reproductive toxicity, and possible hormonal effects.

The FDA conducted some MUsT studies and determined that systemic absorption was greater than 0.5ng/ml. More such studies need to be conducted. A MUsT >0.5ng/ml does not indicate that the tested active is not safe—FDA has said as much and stressed that point and stated, “While industry and other interested parties develop further data, the public should continue to use sunscreens with other sun protective measures. Broad spectrum sunscreens with SPF values of at least 15 remain a critical element of a skin-cancer prevention strategy…”¹²

In response to the PO and to meet FDA’s need for additional data, the Personal Care Products Council (PCPC) Sunscreen Consortium was formed. We, the authors, are members of this consortium whose objective is to support the safety and defend the GRASE Category I status of 7 of the 12 “chemical” actives ingredients that are currently listed on the sunscreen monograph via an FDA agreed upon timely and diligent scientific approach which demonstrates progress in obtaining the type of information that FDA requested. The seven active ingredients being supported are: octocrylene, avobenzone, octisalate, homosalate, octinoxate, oxybenzone and ensulizole. These were chosen as the most used by the industry or formulating consumer sunscreen products. The aim of the consortium is to ensure that adequate UV filters remain available to protect the US population from the dangers of UV exposure.

As mentioned, fulfilling these needs is complex and time-consuming. For that reason, FDA indicated that if the industry is diligent and shows satisfactory progress for a specific ingredient in a timely manner, it would be prepared to defer issuance of a final AO regarding the status of sunscreens containing that ingredient.¹³

Environmental Front

The other front of attack is the potential environmental impact of sunscreen actives. It is no surprise that at least since the early 1970s, the use of SPF products has expanded and increased dramatically due to rising consumer awareness of sun-induced health risks such as sunburn, premature skin aging and skin cancer. This increase in awareness is due to the efforts of our industry, the medical establishment, as well as government and non-government authorities that support their public health benefit and use. This resulted in higher use levels of SS actives in products and a plethora of products such as beach, cosmetics and personal care formulas claiming SPF. Despite increased use of sunscreen actives, in the US, skin cancer is the most common cancer and more than 9,000 people are diagnosed with skin cancer every day with more than two people dying every day, according to www.skincancer.org. Sunburns are a contributing factor. Having five or more sunburn episodes doubles one’s risk of developing melanoma. It is estimated that one in five Americans will develop skin cancer by the age of 70.^14,15,16

The increased use of sunscreen actives led some to ask and scrutinize their potential environmental impact, especially on aquatic environments. Do these actives affect aquatic organisms? Some UV filters with wide global use in high amounts, were detected in monitoring studies in both freshwater and marine environments. Some studies linked the use of sunscreens to affect biota such as coral. Coral bleaching has been attributed to sunscreen beach products. This led some state legislators to hastily ban some sunscreens although the results were incomplete, not conducted using scientifically vigorous or validated test methodologies, and not by any means conclusive. That is the situation in Hawaii.

A ban on oxybenzone and octysalate went into effect Jan. 1, 2021. Stricter regulations were put in place at the county level. With no evidence whatsoever, Maui County banned all nonmineral sunscreens. The ban includes all 12 “chemical” sunscreens currently considered GRASE Category III on FDA’s sunscreen monograph. These are the ones that FDA and other prominent medical institutions have indicated help protect people from sunburn, skin cancer and early skin aging caused by the sun when used as directed with other sun protection measures.¹⁷ These are the ones the sun care industry is spending so much time, money and energy to develop the additional data that FDA has indicated is needed to support their GRAS Category I status. Is it for naught? This limitation on products that can be used, is hazardous to Hawaiians who face the harmful effects of UV radiation and sets a dangerous precedence for the rest of consumers. This county regulation went into effect October 2022. Hawaii County followed suit and its ban went into effect this month. For the purpose of these bans, “sunscreen” means a product marketed or intended for topical use to prevent sunburn; i.e., beach products. Sunscreen does not include products marketed or intended for use as a cosmetic for the face.

Given this seemingly absurd situation where social decisions are made in the absence of real data, a more balanced approach to understanding the question of whether sunscreens potentially impact the aquatic environment has been brought forth in a recent US National Academies of Sciences, Engineering, and Medicine (NASEM) Report that was mandated by Congress under the direction of the US EPA due to concerns raised about the potential toxicity of sunscreens to a variety of marine and freshwater aquatic organisms, particularly corals and concerns that people will use less sunscreen rather than substituting sunscreens with UV filters that are considered environmentally safe.¹⁸

In general, the report reinforces the public health benefits associated with the use of broad-spectrum sunscreens and the importance of formulation flexibility to drive consumer use. It makes the following conclusions and recommendations regarding their potential environmental impact:

There is currently insufficient relevant and reliable scientific data to conduct realistic environmental risk assessments (ERAs), as such there is not enough scientific data to support sunscreen ingredient bans and 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.

EPA should conduct an ecological risk assessment (ERAs) for all currently marketed UV filters and any new ones that become available to characterize the possible risks to aquatic ecosystems and the species that live in them.

The results of the ERA should be shared with FDA for their considerations of the environment in their oversight of UV filters.

EPA, partner agencies (e.g., NOAA, FDA, NIH, CDC, NSF, DOI), and sunscreen formulators and UV filter manufacturers should conduct, fund or support, and share research and data on sources, fate processes, environmental concentrations, bioaccumulation studies, modes of action, and ecological and toxicity testing for UV filters alone and as part of sunscreen formulations. Additionally, epidemiological risk modeling and behavioral studies related to sunscreen usage should be conducted to better understand human health outcomes from changing availability and usage.

Future research should adhere to international or national standards where applicable. This may include new national/international standards. Public access and transparency in all data and research outcomes is critical.

The Future?

We expect the restrictive Hawaii County regulation to become a statewide regulation. We hope the recommendations made by in the NASEM report: “Review of Fate, Exposure and Effects of Sunscreens in Aquatic Environments and Implications for Sunscreen Usage and Human Health,” will lead to a more scientifically-sound basis for making other state, local and federal regulatory and legislative decisions related to this important public health product category.

To take a passage from Michael Crichton’s book, “State of Fear,” “so the real question with any environmental action is, do the benefits outweigh the harm? Because there is always harm.”

So, sunscreens are threatened on two fronts that could dramatically alter the industry.

Sunscreen use is vital. We believe at the end of the day, there would be a balance between how sunscreen use affects the environment and human health and how to counterbalance environmental effects with the benefits on human health. Regardless, continued support for the all-around safe use of sunscreen products, must continue. 

References

1. OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse09242021.pdf (fda.gov)
2. Environmental Impact Statement (EIS) for Certain Sunscreen Drug Products, FDA
3. https://www.federalregister.gov/documents/2021/05/13/2021-10091/intent-to-prepare-an-environmental-impact-statement-for-certain-sunscreen-drug-products-for
4. Federal Register: 43 Fed. Reg. 37979 (Aug. 25, 1978). (loc.gov)
5. 01-32086.pdf (govinfo.gov)
6. Federal Register: Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use
7. FDA advances new proposed regulation to make sure that sunscreens are safe and effective, FDA
8. FDA Takes Steps Aimed at Improving Quality, Safety and Efficacy of Sunscreens, FDA
9. OTC Monographs@FDA
10. Questions and Answers: FDA posts deemed final order and proposed order for over-the-counter sunscreen, FDA
11. FDA advances new proposed regulation to make sure that sunscreens are safe and effective, FDA
12. Shedding New Light on Sunscreen Absorption, FDA
13. An update on sunscreen requirements: The deemed final order and the proposed order, FDA
14. https://www.skincancer.org/skin-cancer-information/skin-cancer-facts/#:~:text=1%20in%205%20Americans%20will,for%20melanoma%20is%2099%20percent
15. https://www.aad.org/media/stats-skin-cancer
16. https://www.cdc.gov/cancer/skin/index.htm
17. https://www.fda.gov/consumers/consumer-updates/tips-stay-safe-sun-sunscreen-sunglasses
18. https://nap.nationalacademies.org/catalog/26381/review-of-fate-exposure-and-effects-of-sunscreens-in-aquatic-environments-and-implications-for-sunscreen-usage-and-human-health

The viewpoints expressed in this article are those of the authors and do not necessarily reflect those of any Competent Authority or their respective companies. The purpose of this article is to guide and inform the reader. The reader is encouraged to verify any opinions and facts the authors present.