It’s the first day of summer…but in many parts of the country, the sun’s already been blazing. While you probably know you ought to be wearing sunscreen year-round, applying SPF is particularly important in the warmer seasons. As the United States Environmental Protection Agency (EPA) has pointed out, this is when the sun’s rays are stronger, and many of us spend more time being exposed to them outside.

But lately, you may have heard rumblings that some sunscreens may actually be harmful. Sources have claimed ingredients in sunscreen can cause hormonal problems and skin sensitivity, or even increase the risk of some cancers.

The Healthy @Reader’s Digest took on an investigation about the state of sunscreens and our health. The findings were enlightening, but they take some understanding. Our research also highlighted how sunscreen regulation in the U.S. is nuanced, and why few regulatory updates on sunscreen have been enacted in almost 50 years.

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Shedding light on the Environmental Working Group’s annual sunscreen report

Each spring, the Environmental Working Group (EWG) releases an annual guide assessing the safety and efficacy of sunscreen products sold in the U.S. in efforts to help the public make sense of which consumer products contain ingredients that could actually be doing you harm. The EWG is a non-profit, non-partisan advocacy group founded in 1993 to help protect American’s environmental health by working to change industry standards.

Carla Burns, EWG’s senior director for cosmetic science, explained to The Healthy that the group uses a computer-based modeling system to score products based on a mix of their percentage of active ingredients and health harms associated with their formulas. Burns informed us that all the data they use to generate these scores can be found on product labels.

She also revealed there were a handful of takeaways from this year’s report, but that one of the most important is that many sunscreens sold in the U.S. are not guaranteed to be safe or effective. “Out of the 1,850 products we reviewed, only around one-quarter met EWG standards for efficacy and ingredients of concern,” Burns explained. She said the report also highlights the lack of federal regulation and evolution in the regulatory space.

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Dermatologists’ take on current sunscreen research

On paper, the EWG report’s results may be enough to turn some people off sunscreen altogether. But according to dermatologists not involved in the report, these findings need to be taken with a major grain of salt.

Adam Friedman, MD, FAAD, who is a professor and the chair of dermatology at the George Washington School of Medicine and Health Sciences in Washington, D.C., says it’s important to acknowledge that the EWG is providing a service with their advice to the public with respect to the safety of sun protective approaches, specifically sunscreen.

However, Friedman says, the organization may be “taking some liberties with the data available.”

“The facts we know are this: UV rays are a carcinogen as designated by the World Health Organization, and the connection between unprotected sun exposure and skin cancer is well documented,” Friedman said. He added that there is also solid scientific evidence that unprotected exposure to UV rays can accelerate skin aging and contribute to the development of fine lines, wrinkles, and sun spots.

Friedman worries that putting such definitive claims out in the public will potentially scare people off from using sunscreen. Sunscreens do have limitations, he says; but when they’re used appropriately, they’re a very important part of your overall sun protection plan. “There’s really no question: sunscreens will always play a very important role in how we protect people from the harmful effects of the sun.”

Darrel Rigel, a clinical professor and the director of the Melanoma Surveillance Clinic at the Mt. Sinai Icahn School of Medicine in New York City, adds that there’s fact in the EWG report, but the conclusions are a bit off.

So how should you interpret all this? Here’s what to keep in mind for finding a safe, and effective, sunscreen.

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A brief history of sunscreen regulation in the U.S.

Since 1978, the Food and Drug Administration (FDA) has regulated sunscreens as over-the-counter drugs because these products make a health claim—the health claim being that they reduce the risk of skin damage and skin cancer. Many other countries regulate sunscreens as cosmetic products.

The last time the FDA updated sunscreen regulations was in 1999 when they sought to amend the Over-the-Counter (OTC) Drug Monograph Process, a regulatory rulebook of sorts for OTC sunscreen products. But the final monograph (which was actually initiated in 1978) has never actually come into effect.

Andrews explains the OTC monograph regulating sunscreens was never finalized because of delays, inactions, extended comment periods, changing use patterns for sunscreens, pushback on stronger UVA standards, and other setbacks. The FDA released an Enforcement Policy to help regulate the industry until a formalized monograph came into effect and released final labeling and effectiveness testing rules for sunscreens in 2011.

In 2019, the FDA released a new proposed rule on sunscreens, which primarily sought to revise:

• The requirements for sunscreen active ingredients
• Maximum allowable sun protection factor (SPF) limits
• Broad spectrum requirements for products with SPF 15 or higher, such that products must display adequate protection against both ultraviolet A and B rays
• Allowable dosage forms (creams, lotion, or sprays)
• How sunscreens are labeled to make it easier for consumers to identify key information

But not long after the 2019 new proposed rule on sunscreens was released, it received a major blow when Congress enacted the 2020 Coronavirus Aid, Relief, and Economic Security Act, also known as the CARES Act in March 2020.

While a majority of the CARES Act deals with ways to provide economic relief, it also effectively modernized and reformed the way the FDA regulates some OTC drugs, including sunscreen. Most importantly, the CARES Act scratched the monograph system and replaced it with an administrative order process to add or change regulations. According to the FDA, “the administrative order process is expected to improve efficiency, timeliness, and predictability in the OTC Drug Review process.”

The CARES Act also required the FDA to establish a “deemed final order” on sunscreens and that the FDA issue a proposed order to amend and revise the deemed final order.

While the issue is extremely complex, the FDA’s deemed final order to fulfill CARES Act requirements contained several major departures from the 2019 proposed rule, including:

• Automatically providing GRASE (“generally recognized as safe and effective”) status to 16 active ingredients previously without GRASE status
• Scratching the idea of a maximal allowable SPF value
• Not requiring products to have broad-spectrum testing
• Not requiring GRASE status for dosage forms
• Sticking with 2011 labeling requirements

The subsequent proposed rule the FDA released to amend the deemed final order reverses almost all of these departures from the 2019 proposed rule.

Is your sunscreen delivering the SPF it claims to?

We’ve all heard about SPF, but most of us don’t really know what it means.

In basic terms, SPF (sun protection factor) measures how much UV radiation is necessary to cause skin reddening on protected skin relative to the quantity of UV radiation required to impact unprotected skin.

According to David Andrews, PhD, a senior scientist at EWG, the FDA requires sunscreen manufacturers to conduct two tests to support their SPF labeling claims. He explains manufacturers must conduct a “valid” SPF test on 10 people, which measures skin redness on a person’s back in response to a high-intensity UV light.

Companies can choose the laboratory where the test is conducted, he says, but it must follow FDA guidance on factors like the thickness of sunscreen application and the emissions and UV profile of lamps used to produce UV light.

In the fall of 2021, the EWG published a peer-reviewed study in the Journal of Photodermatology, Photoimmunology and Photomedicine in which they used laboratory testing and computer modeling to assess the SPF protection of sunscreen products sold in the U.S. In total, they tested the efficacy of 51 products with labeled SPF values ranging from SPF 15 to SPF 110.

It’s arguable that the results of the study were concerning. On average, most products that were tested offered around 50 perfect of the SPF protection their labels claimed.

While the EWG report’s findings may give some pause, Friedman says it’s hard to interpret the true impact of their results. “The study they cite is not a clinical study, rather a lab-based study, which doesn’t translate to human use,” he says, explaining the study’s results were generated using computer modeling and ex-vivo testing, and not tested on actual human skin.

He adds that in the world, sunscreens may also offer less protection than their labels claim due to user error. This includes not applying sunscreen liberally or frequently enough to meet the guidelines or rates used in clinical testing—which, he says, “almost no one does.” If a sunscreen product has expired, or sat in the heat for a long time, their active ingredients may also break down and be less effective. You also need to shake most sunscreens well before using them to make sure ingredients are uniformly distributed inside the container.

The experts also want you to know that no sunscreen, regardless of its SPF value, can completely stop UV radiation from reaching your skin.

And contrary to common beliefs, SPF values are calculated based on the amount of UV radiation exposure, not the length of exposure. This means the same SPF value will offer protection for shorter periods in accordance with the sun’s intensity, which varies throughout the day.

According to the FDA, one hour of UV exposure at 9:00 a.m. and 15 minutes of exposure at 1:00 p.m. expose you to a similar amount of UV radiation. This helps explain why authorities urge you to avoid sun exposure during peak UV hours, in particular between 10 a.m. and 4 p.m.

Are you getting enough UVA protection?

Most of us know about the harms associated with UVB rays, the major sunrays responsible for skin reddening and burns.

Yet fewer people are familiar with the harms associated with UVA rays, despite the fact that they account for up to 95 percent of the radiation from the sun that hits the Earth’s surface. And unlike UVB rays, UVA rays stay consistently strong and penetrate through glass, regardless of the time of day or weather. UVA rays are also largely responsible for skin tanning and premature skin aging because they penetrate the skin deeper than UVB rays.

To meet growing concerns about UVA protection, companies began offering products with so-called “broad-spectrum” protection, meaning they contained protection from both UVB and UVA rays.

Yet it wasn’t until 2011 that the FDA set guidelines to ensure broad-spectrum products met standards for UVB and UVA protection. (It’s important to note that the FDA doesn’t actually test individual sunscreens, so companies themselves are responsible for testing their product’s safety, efficacy, and quality.) The most recent proposed order would expand on these guidelines, requiring that all labelled broad-spectrum products with SPF 15 or higher would need to provide independent evidence their products offer a UVA I / UV ratio of 0.7 or higher.

In EWG’s 2021 peer-reviewed study, only 18 of 51 products tested met European sunscreen UVA protection standards. In addition, on average products tested in a lab only offered half the true total SPF protection stated on their labels. Andrews says these findings are consistent with comments Proctor and Gamble (P&G) submitted to the FDA in 2011. He says P&G sent an off-the-shelf SPF 100 product to five different labs and the results came back significantly lower from every lab.

Further complicating the UVA matter is the fact that the FDA has approved very few UVA-protective active ingredients.

“Right now there are only two real ingredients with good UVA protection allowed in the U.S., which is avobenzone and zinc oxide,” says Burns. And under current proposed FDA regulations, only zinc oxide is considered GRASE.

Burns says it can be hard to know what percentage or composition of ingredients you need to get good UVA protection. “We really just encourage people to look for products that contain key ingredients associated with UVA protection,” she explains. In the case of products sold in the US, as long as a product contains avobenzone or zinc oxide, it probably provides adequate UVA protection.

Should I be worried about using products with oxybenzone?

According to the available research, the jury is still out as to whether the UV filter oxybenzone is safe.

“Studies show that oxybenzone is readily absorbed into the skin and enters the bloodstream,” Burns told us. “It can also be a skin sensitizer and cause some pretty nasty skin reactions. There are also studies out there that suggest it can impact hormone regulation.”

Currently, the FDA claims there is not enough scientific evidence to deem that oxybenzone is GRASE. But Rigel and Friedman point out that a lack of evidence does not indicate that a sunscreen ingredient is not safe—it simply means we don’t have enough research results to conclude either way. And, our experts note, just because something can be absorbed into the bloodstream doesn’t mean it’s harmful or toxic.

Friedman also points out that the studies the report references were not looking at safety, adding “this is a common misinterpretation of these JAMA [Journal of the American Medical Association] studies.”

Instead, Friedman says the studies were conducted to prove that technology could detect nanomolar concentrations of these ingredients in the bloodstream after maximal sunscreen application. “Almost no one in the real world applies enough sunscreen to achieve maximal application,” he says, which would require applying the sunscreen from head to toe, multiple times a day, at a rate of two milligrams of sunscreen for every square centimeter of skin. “These controlled studies don’t mirror real-world sunscreen use.”

Rigel adds that the studies that linked oxybenzone with hormone disruption were conducted in rats that were fed very high doses of oxybenzone. He says further research found that it would take humans around 35 years of head-to-toe application of an oxybenzone product to achieve the level of systemic exposure in the rat study. Less liberal application of products with oxybenzone would result in it taking around 277 years of daily application to create the systematic levels of oxybenzone found in the rats.

A 2020 systemic review published in the International Journal of Dermatology also claims there’s not sufficient evidence to link elevated levels of oxybenzone in the blood with adverse health effects. In particular, the review found that elevated blood levels of oxybenzone did not have a negative impact on:

• Male and female fertility or female reproductive hormone level
• Adiposity, or having too much fatty tissue
• Fetal growth
• Children’s neurodevelopment and sexual maturation

Yet the authors of the review point out the impact of oxybenzone blood levels on thyroid hormones, testosterone levels, pubertal timing, and kidney function requires further research. A 2021 report claims that sunscreens should only be considered safe if they contain no more than 2.2 percent oxybenzone. In the U.S., sunscreens are allowed to contain up to six percent oxybenzone.

Some expert sources also say that until we know more about oxybenzone, because it can enter breast milk, pregnant or breastfeeding women may want to stay clear of products that contain it.

These may be the 2 safest sunscreen ingredients

Of the 16 active sunscreen ingredients allowable in the U.S., only two—zinc oxide and titanium oxide—will be deemed GRASE if the most recent proposed order comes into effect. In comparison to other countries, the EU allows eight additional active sunscreen ingredients than the U.S., while Australia allows some 30 active ingredients.

Based on the current proposal, the sunscreen ingredients aminobenzoic acid (PABA) and trolamine salicylate are not GRASE because there is evidence that they are not safe for human use. Trolamine salicylate can cause serious bleeding and toxicity, while PABA can cause serious allergic responses and adverse reactions with commonly used medications.

And under the current proposal, the following 12 ingredients are not recognized as GRASE because more data is needed to determine their safety:

• Cinoxate
• Dioxybenzone
• Ensulizole
• Homosalate
• Meradimate
• Octinoxate, octisalate, and octocrylene
• Padimate O
• Sulisobenzone
• Oxybenzone
• Avobenzone

While the experts all agree that zinc oxide and titanium oxide have proven to be fairly safe and effective, Rigel and Friedman say they do have some drawbacks.

“Zinc oxide and titanium dioxide really only create a surface coat of protection, which means they’re not as water or sweat resistant as some organic active ingredients,” Rigel says.

Inorganic active UV ingredients like zinc oxide and titanium oxide contain metal oxide particles that form a physical barrier on the top of the skin and absorb harmful UV radiation that they then release in the form of heat.

Organic active UV ingredients (most other active ingredients in sunscreens) both filter out and absorb harmful UV rays. The term organic in this case refers to the fact that they’re mostly made by chemists out of carbon. Organic active UV ingredients are manufactured chemicals, whereas inorganic active UV ingredients are naturally occurring minerals.

There’s also some concern that zinc and titanium dioxide nanoparticles may be able to penetrate the skin.

Friedman explains that a very small study from 2010 found that at maximal use a trace about of elemental zinc was detected in participants’ blood several days later. But he explains that at the nanoscale level, metals like zinc spontaneously kick off particles into the environment. So the trace amount of elemental zinc found in subjects in the 2010 study could have came from environmental sources, not the sunscreen.

Other study’s sponsored by the FDA and EU have also concluded zinc and titanium dioxide nanoparticles do not penetrate through the skin. And an Italian study from 2015 concluded that titanium dioxide nanoparticles did not penetrate the skin, even when it was damaged.

Friedman says that based on all of this evidence, the EU has ruled that topically applied nanoparticles are safe. He adds the EU is still trying to figure out whether spray sunscreens with metal nanoparticles are safe, given their potential for inhalation.

How to choose a safe and effective sunscreen

At the end of the day, the experts say you may never be able to pick the perfect sunscreen.

However, Rigel’s advice is to choose products with broad-spectrum UV protection that contain both organic and inorganic active ingredients. Groups like the Skin Cancer Foundation recommend picking products with at least SPF 15 and opting for water-resistant and SPF 30+ products if you’re going to spend longer periods outdoors.

But the facts about whether many active ingredients in sunscreens are safe are still murky, and it could take years before we know the full story. It will likely take even longer to understand how sunscreen ingredients impact the world around us.

“We’re hopeful that at the end of this year we might get an update from the FDA about their proposals regarding sunscreen regulations,” Burns says. “Hopefully this will enforce higher standards to address what can and cannot be safely used in sunscreens, and bring about more general improvements in sunscreen safety and efficacy.”

Friedman says that regardless of the lingering questions about sunscreen, there’s really no excuse not to wear it. “Sunscreens have been helping prevent skin cancer from sun exposure for decades, “ he says, “and while we do have some things left to learn about their ingredients, a bit of controversy is no good reason to stop using them.”

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Editor’s note: This article was medically reviewed by Sandra Bonat, MD, an endocrinologist on Long Island, NY

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