PCPC provides education and information to help a variety of stakeholders, including consumers, make informed decisions about sunscreens. Sun protection and sunscreens are critical to preventing skin cancer and premature skin aging. The cosmetics and personal care products industry is proud of the innovative sunscreen products we provide to help protect consumers from the harmful effects of the sun’s ultraviolet (UV) rays.
Safety and Regulation of Sunscreens
Sunscreens are regulated by the U.S. Food and Drug Administration (FDA) as over-the-counter (OTC) drugs. As such, they must be shown to be both safe and effective using the FDA testing methods, and comply with all other requirements listed in the FDA’s OTC sunscreen monograph. The FDA’s rigorous sunscreen testing requirements are well recognized by experts and regulatory authorities around the globe. All sunscreens in the U.S. must be tested for sun-protection factor (SPF) performance using the same FDA-designated clinical tests.
Sunscreens Task Force
In collaboration with the Consumer Healthcare Products Association (CHPA), PCPC’s Sunscreens Task Force (TF) actively reviews current and emerging science, regulations and standards that may impact sunscreens. The TF frequently submits comments to the FDA on various topics, such as clinical safety testing requirements, labeling requirements and other topics of interest. It also collaborates with standard-setting organizations to establish viable test methods.
Together with the American Academy of Dermatology (AAD), PCPC is a long-time supporter of the SUNucate program, led by the American Society for Dermatologic Surgery Association (ASDSA) in collaboration with the National Council on Skin Cancer Prevention. This public health initiative spreads awareness about the importance of sun-protective behaviors and works to remove barriers that prohibit access to important sun-protective measures, such as sunscreens and sun-protective clothing.
The initiative’s centerpiece is the SUNucate model legislation, aimed at guaranteeing children have unbarred access to sun protection while at school or camp. The model legislation — Reducing Cancer and Excessive UV Exposure in Children Act — allows students and participants in youth camps to possess and use a topical sunscreens product while on school or camp property, or at an event or activity sponsored by the school or camp, without a physician’s note or prescription.
This initiative was launched in response to reports of schools prohibiting students from possessing sunscreens due to their classification as over-the-counter medications. To date, 26 states and Washington, D.C., have passed SUNucate-related measures, with several other states pending action.
Oxybenzone and Octinoxate Legislation in Hawaii
Legislation in Hawaii banned two important ingredients — oxybenzone and octinoxate, both approved by FDA for use in sunscreens — effective Jan. 1, 2021. Additional legislation to expand the list of prohibited sunscreen ingredients was introduced in Hawaii early in 2021. PCPC shares Hawaiians’ concern for the environment, particularly the coral reefs, and is committed to ensuring all cosmetics and personal care product ingredients, including sunscreen UV filters, are sustainable and do not adversely impact the environment.
Oxybenzone is one of the few FDA-approved ingredients that provides effective broad-spectrum protection from both UVA and UVB radiation, and has been approved for use since 1978. UVA rays penetrate more deeply into the skin and have been scientifically proven to contribute to skin cancer. Only sunscreen products with ingredients protecting against both UVB and UVA rays may be labeled as “broad-spectrum protection,” preventing both premature aging and skin cancer. Octinoxate also plays a critical role in protecting against UVB rays and is essential in many sunscreen formulations.
PCPC remains very concerned that the law prohibiting Hawaiians’ access to sunscreen products with oxybenzone and octinoxate is based on inadequate scientific studies that do not meet required quality controls used by regulatory bodies worldwide. There are well-recognized causes of coral reef decline in Hawaii and around the world, including climate change, land-based pollution and other human activities, such as physical damage to corals from recreational activities, not sunscreens.
Government agencies and environmental organizations — like the National Oceanic and Atmospheric Administration (NOAA), United Nations Educational, Scientific and Cultural Organization (UNESCO) and U.S. Coral Reef Task Force — have identified rising sea temperatures from global warming as the primary causes of coral bleaching. Addressing the major, proven causes of coral reef decline is key to protecting fragile reef ecosystems. To date, there is no convincing scientific evidence that, under naturally-occurring conditions, sunscreen ingredients are contributing to this issue.
The U.S. has a limited number of approved sunscreen ingredients to make products that protect consumers from the harmful effects of solar radiation. Making environmental management decisions on sunscreens based on insufficient scientific data may lead to unintended health consequences, such as fewer available sunscreens and, thus, an increase in the prevalence of skin cancer. There are major knowledge gaps and data reliability issues with the published coral toxicity studies that have been used to justify recent state sunscreen/UV filter restrictions. While we don’t have all of the answers, it is clear that more research into the impacts of UV filters on coral is needed to allow the scientific community to form a consensus based on reliable studies.
Science serves as the foundation for everything cosmetics and personal care products companies do. It’s critical for public health that consumers have ample sunscreen options to meet their needs. PCPC and our member companies seek to provide products, education and information that empower consumers to make informed decisions about the safe use of sunscreens for their families.
- Video Series: What You Need to Know About Sunscreens
- CosmeticsInfo.org: Sunscreens Frequently Asked Questions
- Statement by the Personal Care Products Council and the Consumer Healthcare Products Association on the FDA’s Proposed Administrative Order for Sunscreens: Sept. 27, 2021
- Statement by Alexandra Kowcz, Chief Scientist, Personal Care Products Council, in Response to the Environmental Working Group’s 2021 Sunscreens Guide: May 4, 2021
- Statement from the Personal Care Products Council on Sunscreen Regulations in COVID-19 Legislation: March 27, 2020
- Public Comments on FDA’s Sunscreen Tentative Final Monograph: June 27, 2019
- Statement by Alex Kowcz, Chief Scientist Personal Care Products Council On Restricting the Use of Sunscreens in Hawaii: July 3, 2018
- Video: Highlights from the Skin Smart series
- CosmeticsInfo.org: Sunscreens: How to Read a Label, Expert Tips etc.
- Media Coverage: Chemical Watch: Groups push for changes to US sunscreen ingredient approvals