Sunscreen Information

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Jan. 21, 2020 -- New FDA testing of sunscreens shows that six common active ingredients are absorbed into the body and may linger for days or even weeks, in some cases.
What’s more, the testing showed that just a single application of  sunscreen-- whether as a lotion or a spray -- increases the blood levels of these active ingredients beyond the FDA’s threshold for determining if they need more study to be considered safe for use.
“It’s a little bit scary because we just don’t know what the biological effect of sunscreen in your blood is,” says Alok Vij, MD, a dermatologist at Cleveland Clinic in Ohio. Vij was not involved in the study.
Previous research has shown that some of the ingredients in the FDA study can disrupt hormones and may lead to fertility problems, poor birth outcomes for babies, and perhaps cancer.

Read about the labeling on sunscreen

How Sunscreens Escaped Safety Testing
Many Americans dutifully rub or spray sunscreen on their  skin to protect it from the sun’s baking rays.
After decades of public health education, almost anyone who is heading outdoors has heard the message that sunscreen is an important part of protecting skin from sunburns, aging, and  skin cancer. In fact, sun care is a nearly $2 billion-a-year industry in the U.S.
The FDA has allowed sunscreen makers to sell their products under an assumption that the active ingredients they use are “GRASE,” or generally recognized as safe and effective.
But several decades ago, the FDA began requiring manufacturers to do more safety testing of their products if they could be absorbed into the body at levels above 0.5 nanograms per milliliter. Below that level, there’s thought to be minimal risk that an ingredient or drug could cause harm.
“These standards were set in the last couple of decades, but sunscreen has been around for a lot longer than that,” says Kanade Shinkai, MD, PhD, a dermatologist at the University of California, San Francisco. Shinkai wrote an editorial on the current study, but she was not involved in the research.
As a result, sunscreen essentially got grandfathered into the FDA’s surveillance system without any real safety testing.
The agency has been urging the companies that make sunscreens to do more safety studies of their products, but “for various reasons, it just never happened,” Shinkai says.
Finally, the FDA, which has a small research division, decided to take on the question of body absorption of sunscreen ingredients.
Last year, the agency dropped a bit of a bombshell after that testing revealed that four of the most common UV filters in chemical sunscreens -- avobenzone, oxybenzone, octocrylene, and ecamsule -- are absorbed by the body in substantial amounts, and can stay there for days, something that wasn’t well-known before.

The History of Sunscreen

Follow the evolution of sunscreen, from the first recorded ancient Egyptian formula to modern day sunblock.

As a result, the FDA says those four ingredients, along with another eight, need more safety testing before they can be considered GRASE. It has asked sunscreen makers to do that testing. So far, those studies -- which are supposed to look at effects on cancer and reproduction -- haven’t been done.
That’s despite the fact that the FDA gave sunscreen makers a November 2019 deadline to deliver more information.
Instead, some criticized the FDA’s initial testing methods, which had study volunteers reapply their sunscreens every 2 hours for 4 days, saying that most people don’t reapply that often and that the conditions tested in the study were unrealistic.
In response, the FDA redid the study, this time including six active ingredients in chemical sunscreens: avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate. Those ingredients are the UV filters that screen out the sun’s harmful rays.
They tested aerosol and pump lotions and sprays. They had 48 healthy adults -- half were men and half were women -- apply the sunscreens to 75% of their bodies, virtually anywhere a swimsuit wouldn’t cover.
On the first day, they applied the sunscreen just once. On days 2, 3, and 4, the men and women in the study took a shower in the morning, then applied the sunscreen every 2 hours for a total of four applications each day. Researchers took 34 blood samples from each study participant, for those first days of sunscreen use, and then later, after a week, 2 weeks, and 3 weeks, to see how long those chemicals might stay elevated in the body.
“What they did in this study very much mimics what it says on the sunscreen tube,” Shinkai says. “These are not unrealistic. This is real-world. At least the way it’s recommended.”
The new study, which is published in TheJournal of the American Medical Association, largely confirms the findings of the first study.
It shows that the six active ingredients tested were absorbed into the body. Some continued to be elevated beyond the FDA’s threshold of concern for 3 weeks after the people in the study stopped putting them on their skin.
For example, blood concentrations of oxybenzone were more than 180 times the FDA’s level of concern after a single application of sunscreen. They soared to more than 500 times the FDA’s level of concern after 4 days of regular use. Three weeks later, blood tests continued to show higher levels of oxybenzone, though it was much lower than at the start of the study.
Studies have shown that oxybenzone may affect breast development, infant birth weight, and sperm function. It has also been shown to contribute to the killing of coral reefs in the ocean. As a result, Hawaii has banned the sale of sunscreens containing oxybenzone and octinoxate starting in 2021.
“The fact that these chemicals are being found at elevated levels in our blood, combined with evidence that they have been linked to adverse health impacts in other studies, is extremely concerning,” says Nneka Leiba, vice president of the Environmental Working Group’s Healthy Living Science program. The Environmental Working Group has been warning consumers for years that ingredients in chemical sunscreens may not be safe.

FDA REMAINS ASLEEP AT THE WHEEL ON THE DANGERS OF SUNSCREENS, BESIDES OTHER COSMETICS AND PERSONAL CARE PRODUCTS
CHICAGO, IL, August 7, 2008 --/WORLD-WIRE/-- Since 1978, sunscreens have been regulated and labeled by the Food and Drug Administration (FDA) on the basis of their SPF (Skin Protection Factor).

On August 23, 2007, the FDA proposed new regulations for more informative labeling of sunscreens. However, almost a year later, they still remain pending.

In response to FDA’s inaction, and mounting concerns on the unreliability of the SPF, Connecticut Attorney General Richard Blumenthal wrote to the FDA on July 24 criticizing its failure to regulate the sunscreen industry, and prevent it from making “dangerously misleading claims” on the safety and effectiveness of its products.

A week later, Senator Jack Reed (D-Ri) and Christopher Dodd (D-Ct) introduced the “Sunscreen Labeling Act of 2008.” This gave the FDA six more months to finalize comprehensive rules, otherwise the Act would become law.

Sunscreens pose scientifically well documented risks. While well known for over a decade, they remain unregulated by the FDA, and ignored by the industry.

Sunscreens are based on six ingredients, some of which actively penetrate the skin, accumulate in the body, and have been identified in urine and breast milk.

More ominously, these ingredients have toxic hormonal effects, known technically as “endocrine disruptive.” Evidence for these effects has been well documented over the last decade. This includes stimulation of human breast cancer cells in test tube experiments, and increased uterine growth in immature female rats following skin painting or feeding.

Sunscreens block short wave ultraviolet light (UVB), which is responsible for sunburn. This encourages prolonged exposure, particularly of children. Moreover, sunscreens are ineffective against long wave ultraviolet light (UVA), which is responsible for malignant melanoma, the fastest growing known cancer. As a result, its incidence has increased by 130%, and its mortality has increased by 26% since 1975. FDA’s continuing regulatory failure in this regard reflects the reckless indifference to consumer product safety of its Commissioner Dr. Andrew von Eschenbach, former director of the National Cancer Institute.

Of major concern, and still ignored by the FDA, is the increasing addition to sunscreens of unlabeled atom or molecule size zinc oxide or titanium dioxide particles. Technically known as nanoparticles, they increase the durability and effectiveness of these products. However, as reported in over two dozen scientific publications since 2003, including those by an Environmental

Protection Agency research team and the International Center for Technology Assessment, nanoparticles can penetrate the skin, invade blood vessels, and produce devastating distant toxic effects.

FDA’s regulatory failure extends from sunscreens to a wide range of other dangerous ingredients in cosmetics and personal care products. Of illustrative concern is FDA’s reckless failure to respond to November 1994 and May 2008 Citizen Petitions, by the Cancer Prevention Coalition, “Seeking a Cancer Warning on Cosmetic Talc Products,” used for feminine hygiene. As detailed in these Petitions, talc is a major avoidable cause of ovarian cancer, a relatively rare cancer at any age, whose incidence has escalated dramatically by 12% for white and 32% for black women, with about 15,000 deaths annually. This makes it the fourth most common fatal cancer after breast, colon and lung.

The “Sunscreen Labeling Act” should be the first step to developing a comprehensive “Cosmetics and Personal Care Products Labeling Act.” This could be modeled along the lines of California’s precedential 2007 Safe Cosmetics Act.

As warned by Senator Edward Kennedy (D-Ma) at September 10, 1997 Hearings on the FDA Reform Bill, “The cosmetics industry has borrowed a page from the playbook of the tobacco industry by putting profits ahead of public health.” This warning remains recklessly unheeded by the FDA.
What Now?
The FDA says that while the UV filters in chemical sunscreens can’t be considered safe, that doesn’t mean they’re unsafe. Scientists just don’t know.
So what should you do if you want to protect yourself or your kids from the uncertainties of untested ingredients?
Vij says he reminds his patients that sunscreens are just one part of sun protection.
“Avoid sun if you can between 11 and 4, when UV radiation is at its peak,” he says. “Use mineral-based sunscreens or use clothing that has built-in sun protection.”
Vij tells his patients to look for clothing that has a UPF factor.
It’s a little bit scary because we just don’t know what the biological effect of sunscreen in your blood is.
Alok Vij, MD, a dermatologist at Cleveland Clinic in Ohio.
“Be smart in the sun. If you know you burn, limit your sun exposure. If you know you have a family history of melanoma, limit your sun exposure,” he says.
One big knowledge gap is kids. There’s very little information about how they might be absorbing sunscreen ingredients or what those ingredients might be doing to a growing body.
For children especially, Shinkai says, it is smart to look for mineral-based sunscreens. Those include sunscreens that contain the ingredients zinc oxide or titanium dioxide. The FDA says both of those ingredients are safe.
She acknowledges that it can be harder to apply and it turns the skin white, which sometimes isn’t acceptable, especially to people with darker skin tones.
“Mineral sunscreen, if formulated correctly and applied correctly, is very effective,” she says.
Shinkai recommends looking for products that combine zinc and titanium.
“A lot of formulations have zinc only. They miss part of the UV spectrum. Mixing them together -- zinc and titanium -- provides broad-spectrum protection that’s very comparable to what you get in a chemical sunscreen,” she says.
“There’s no reason for us to not recommend mineral sunscreen.”
WebMD Health News Reviewed by Neha Pathak, MD
Sources
Article: FDA Sunscreen Report Raises Concern Over Chemicals
Alok Vij, MD, dermatologist, Cleveland Clinic, Cleveland, OH.
Kanade Shinkai, MD, PhD, dermatologist, University of California, San Francisco; editor-in-chief, JAMA Dermatology.
Nneka Leiba, vice president, Healthy Living Science program, the Environmental Working Group, Washington, D.C.
JAMA: “Systemic Absorption of Sunscreen: Balancing Benefits With Unknown Harms.”
JAMA: “Filling in the Evidence About Sunscreen.”
News release, FDA, Feb. 21, 2019.
Video: The History of Sunscreen
JAMA Network: “The History of Sunscreen.” NCBI: “The historical aspects of sunscreens.” Skin Cancer Foundation: “Challenges in Making an Effective Sunscreen.” The New York Times: “Sunscreen: A History.” NPR: “Many Common Sunscreens May Harm Coral.

Safe sunscreen at PureHaven.com