In the last few years, some controversy has surrounded the use of certain chemical sunscreens and their safety. In addition, SPF ratings have been questioned as to their accuracy.
The article below was taken from the EWG (Environmental Working Group) website. As a professional, multi-disciplined esthetician, I am always researching scientific data on the ingredient safety of cosmetics and concerns about environmental issues that affect the health and well-being of us all. The EWG is one source for my personal and professional research.
The EWG is a dedicated research group that does scientific research and data analysis into areas of concern for the health and well-being of consumers. Their research encompasses not only chemicals and practices used in cosmetics – also our environment, agriculture, the food we consume, the air we breathe, water, and other concerns that affect our health.
I want to share with the readers of my website and blogs the research and data that will affect the proposed FDA rulings on chemical sunscreen safety and proposed SPF language. I chose this excerpt from the report the EWG put forth on sunscreens. I feel it gives understandable, comprehensive, and researched information on this subject. The FDA is set to put forth their rulings and recommendations later in 2021.
SPECIAL NOTE: OXYBENZONE is a chemical sunscreen of great concern. I have recommended, for several years, my clients STAY AWAY from any sunscreen with this ingredient! In multiple research studies it has been found to be a potential endocrine disruptor.
The article below, will give you comprehensive information on what the FDA is considering for their new regulations on sunscreen chemical safety and SPF labeling. In addition, they have recommendations on what they consider to be consumer friendly sunscreen products.
In Health and Beauty,
Kathleen Peara
Sunscreens in 2021
Sunscreen regulations have not been updated since 2011. In 2019, the FDA released a draft monograph, with a goal of updating sunscreen regulations that year. However, due to changes in the way over-the-counter-drugs are regulated, the proposal was withdrawn in the first coronavirus relief bill. The FDA is due to propose new sunscreen regulations this fall.
The FDA’s previous proposal recognized just two ingredients as safe and effective, zinc oxide and titanium dioxide. EWG has always recommended that consumers choose sunscreen products made with these ingredients, which meet our standards for effectiveness and safety.
In 2019, the FDA proposed that 12 other active ingredients commonly found in sunscreens, including oxybenzone, need additional data from safety and efficacy tests.[1] Those ingredients are used in about 60 percent of the sunscreens assessed in this year’s guide. The FDA requested the same data for these ingredients that the agency requires for ingredients used elsewhere in the world that companies want to use in U.S. sunscreens.
Particular concern about oxybenzone – especially for kids
Oxybenzone is a commonly used active ingredient in sunscreen, found in about 20 percent of the products assessed this year, including 40 percent of the non-mineral options. In 2008, EWG first called on the FDA to investigate the safety of oxybenzone in sunscreen, because of mounting evidence that the chemical readily penetrates the skin and could potentially disrupt the hormone system.
In 2019 FDA proposed that oxybenzone could not be classified as safe and effective based on the current data. The FDA stated that although oxybenzone is one of the more thoroughly tested sunscreen ingredients, additional data is needed, because existing tests raise health concerns. Of particular concern to the FDA were test results showing:
- Oxybenzone is allergenic.
- It is absorbed through the skin in large amounts.
- It has been detected in human breast milk, amniotic fluid, urine and blood.
- It is a potential endocrine disruptor.
- Children may be more vulnerable than adults to harm from oxybenzone “because of the potential for higher absorption and bioaccumulation.”
- The agency requested studies of oxybenzone that measure skin absorption and potential impacts on the hormone levels, reproduction and development.
Four studies published in 2020, after the FDA proposal, support previous findings that oxybenzone can act as an endocrine disruptor and may increase the risk of breast cancer and endometriosis.
The FDA wants to ban the highest SPF claims, limiting SPF values to 60+
According to the FDA’s 2019 proposal, higher SPF values have not been shown to provide additional clinical benefit and may provide users with a false sense of security. To guard against this misconception, the agency proposes limiting products’ SPF claims to 60+.[2]
The FDA proposal highlighted concerns that claims of excessively high SPF values give users a false sense of protection, leading to overexposure to UVA rays that increase the risk of long-term skin damage and cancer. The FDA emphasized that the SPF cap, along with proposed changes to the broad-spectrum test, are needed to ensure that sunscreens provide more UVA protection.
In 2011, the FDA published a recommendation for an SPF cap of 50+, but that proposal was never finalized. We see the latest proposal, recommending a cap of 60+, as a step backward. To justify this change, the FDA only cites studies of sunscreens with active ingredients that are not allowed for use in the U.S. Therefore, it remains unclear whether this change will be feasible or beneficial to the U.S. market.
More than one in ten of the sunscreens we reviewed claim on the label to having an SPF greater than 50+. EWG recommends consumers avoid products that claim an SPF higher than 50+.
FDA proposes raising the standard for UVA protection
The FDA proposal recommends changes to the method companies must use to evaluate sunscreens’ broad-spectrum UVA protection. The agency proposes a test it initially put forward in 2007 to ensure greater UVA protection. At the time, sunscreen manufacturers fought this change and the agency relented, enabling substandard and potentially harmful products to remain on the market for a decade more. A study by FDA scientists in 2020 confirmed that current products on the U.S. market with similar SPF may provide vastly different UVA protection, raising concerns about long-term health harm.
The EWG UVA protection standard is stronger than what the FDA proposed in 2019 and even goes beyond what is required in Europe.
FDA proposes that all spray products undergo additional safety testing
Sunscreen sprays pose an inhalation risk and may not coat the skin enough to ensure proper protection. The number of sunscreen sprays on the U.S. market has been increasing, and more than a quarter of the sunscreens in this year’s guide are in spray form.
The FDA proposed that all spray and powdered sunscreens be tested to ensure they cannot be inhaled deep into the lungs, where they could do irreversible damage. In pilot testing, the agency found that three of 14 sprays would not meet its proposed standard but did not say which products consumers should avoid. EWG recommends that consumers avoid all spray and powder sunscreen products.
The agency has also proposed numerous other changes to the sunscreen regulations that should better protect consumers, including:
- Banning sunscreens and bug repellent combination products.
- Improving product labeling.
- Ensuring that all products with an SPF over 15 provide UVA protection.
The changes proposed by the FDA focus on effectiveness and the safety of active ingredients. They do not address concerns EWG has raised about the use of other worrisome ingredients, such as retinyl palmitate, a form of vitamin A. Vitamin A-based ingredients are unstable in the sun, and it is not certain they are safe in products intended to be worn in the sun.
Consumers should make sun safety a daily habit and not wait for new FDA sunscreen rules – whenever they may happen. Sun safety involves covering up with clothing, seeking shade, planning around the sun, and using sunscreen when needed.
Enjoy the summer and don’t get burned.
[1] Besides oxybenzone, they are avobenzone, homosalate, octinoxate, octisalate, octocrylene, cinoxate, dioxybenzone, ensulizole, meradimate, padimate O and sulisobenzone.
[2] A cap of 60+ means that although companies may consider their product’s formulation to have a higher SPF value than 60, they can’t label it with a higher number.
Article Credits
Introduction – Kathleen Peara – KATHLEEN PEARA SKINCARE FOR LIFE LLC
“Sunscreens 2021” – excerpted from “EWG’S 15th Annual Guide for Sunscreens”
www.ewg.org