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The Trouble With Ingredients in Sunscreens

Sunscreen is a body care product that consumers are directed to apply a thick coat over large areas of the body and reapply frequently. Thus, ingredients in sunscreen should not be irritating or cause skin allergies, and should be able to withstand powerful UV radiation without losing their effectiveness or forming possibly harmful breakdown products. People might inhale ingredients in sunscreen sprays and ingest some of the ingredients they apply to their lips, so ingredients must not be harmful to lungs or internal organs. Furthermore, sunscreens commonly include ingredients that act as “penetration enhancers” to help the product adhere to skin. As a result, many sunscreen chemicals are absorbed into the body and can be measured in blood, breast milk and urine samples.

For these reasons, the Food and Drug Administration is now proposing significant changes in how sunscreen ingredients are evaluated for safety. FDA is proposing that all current and potential new ingredients be adequately tested for safety, including with  studies to determine whether the ingredients penetrate the skin and can cause endocrine disruption, cancer or other health harms.

FDA has put the entire sunscreen industry on alert by proposing that in just two instances do we have enough safety information about ingredients to determine whether they’re safe and effective: zinc oxide and titanium dioxide. For 12 other ingredients, the FDA has said there isn’t enough data to determine whether they’re safe. In particular, FDA raised concerns about the substantial skin absorption of oxybenzone, its potential to affect hormone levels and the increased absorption susceptibility of children (FDA 2019). Lab studies shows that some chemical UV filters may mimic hormones, and physicians have reported sunscreen-related skin allergies, which raises important questions about unintended human health consequences from frequent sunscreen application.

Active ingredients in sunscreens function as either mineral or chemical UV filters that keep harmful rays from the skin. Each uses a different mechanism for protecting skin and maintaining stability in sunlight. The most common sunscreens contain chemical filters. These products typically include a combination of two to six of the following active ingredients: oxybenzone, avobenzone, octisalate, octocrylene, homosalate and octinoxate. Mineral sunscreens use zinc oxide and/or titanium dioxide. A handful of products combine zinc oxide with chemical filters.

When the FDA began to consider sunscreen safety, it grandfathered in active ingredients from the late 1970s without reviewing the evidence of their potential hazards. In February 2019, the agency released its final draft sunscreens monograph, which contains insufficient health and safety data to designate 12 of the 16 sunscreen filters allowed for use in the U.S. as generally recognized as safe and effective, or GRASE. These 12 ingredients include some of the most commonly used UV filters, including oxybenzone, octinoxate, octisalate, octocrylene, homosalate and avobenzone. According to the agency, “nearly all of these sunscreen active ingredients … have limited or no data characterizing their absorption.”

Drawing on the available literature, the agency concluded that the risks of using aminobenzoic acid (PABA) and trolamine salicylate outweigh their benefits, and it proposed classifying them as unsafe. The FDA monograph giving the GRASE designation to just two active sunscreen ingredients: zinc oxide and titanium dioxide.

The Danish EPA reviewed the safety of active ingredients in sunscreen and concluded that most lacked enough information to establish their safety (Danish EPA 2015). In the case of 16 of the 19 ingredients studied, there was no information about their potential to cause cancer. And though the published studies suggest that several chemical filters interact with human sex or thyroid hormones, there was not enough information about any of them to determine the potential risks to humans from hormone disruption.

EWG has reviewed the existing data about human exposure and toxicity for the nine most commonly used sunscreen chemicals. The most worrisome is oxybenzone, which can cause allergic skin reactions (Rodriguez 2006). In lab studies, it is a weak estrogen and has potent anti-androgenic effects (Krause 2012, Ghazipura 2017).

The Centers for Disease Control and Prevention routinely detect oxybenzone in more than 96 percent of Americans. Study participants who reported using sunscreen have higher oxybenzone exposures (Zamoiski 2015). Investigators at University of California, Berkeley, reported a dramatic drop in teen girls’ exposure to oxybenzone in cosmetics when they switched from their usual products to replacements that did not contain this chemical (Harley 2016).

In an evaluation of CDC-collected exposure data for American children, researchers found that adolescent boys with higher oxybenzone measurements had significantly lower total testosterone levels (Scinicariello 2016). The researchers cautioned that their results offer a single-day snapshot; they are not a controlled study of the effect of multiday exposures. The study did not find a similar hormone effect in younger boys or females.

Three other studies reported statistically significant associations between oxybenzone exposure during pregnancy and birth outcomes. One reported shorter pregnancies in women carrying male fetuses; two reported higher birth weights in baby boys; and one found lower birth weights in baby girls (Ghazipura 2017).

Intentional dosing studies of people are rare. In one, volunteers applied a lotion containing oxybenzone and two other sunscreen ingredients. Researchers reported a minor but statistically significant decrease in testosterone in men, accompanied by a minor increase in inhibin B, another male sex hormone (Janjua 2004). The researchers concluded these differences were normal variations and not attributable to sunscreen exposure. In any event, critics argue the exposures were too short to be conclusive (Krause 2012).

According to the latest FDA sunscreens monograph, the agency needs further data to determine the GRASE status of oxybenzone, given that the “available literature … indicat[es] that oxybenzone is absorbed through the skin to a greater extent than previously understood and can lead to significant systemic exposure.… The significant systemic availability of oxybenzone … is a concern, among other reasons, because of questions raised in the published literature regarding the potential for endocrine activity.” Given the pervasiveness of oxybenzone exposures, we need further study to clarify its association with hormone disruption in children and adults.

EWG recommends consumers avoid sunscreens with oxybenzone. But sunscreen users are exposed to other active ingredients too. Margaret Schlumpf of the University of Zurich detected four other sunscreen filters along with oxybenzone in Swiss women’s breast milk, which suggests that the developing fetus and newborns may be exposed to these substances (Schlumpf 2008, Schlumpf 2010). She detected at least one sunscreen chemical in 85 percent of milk samples.

Some experts caution that the unintentional exposure to toxic active ingredients erodes sunscreens’ benefits (Krause 2012, Schlumpf 2010). But most experts conclude that more sensitive tests are needed to determine whether sunscreen chemical ingredients pose risks to frequent users (Draelos 2010, Gilbert 2013).

Active ingredient toxicity

This table outlines human exposure and hazard information for nine FDA-approved sunscreen chemicals. With each sunscreen, we asked these questions:

  • Will the chemical penetrate skin and reach living tissues?
  • Will it disrupt the hormone system?
  • Can it affect the reproductive and thyroid systems and, in the case of fetal or childhood exposure, permanently alter reproductive development or behavior?
  • Can it cause a skin allergy?
  • What if it is inhaled?
  • Are there other toxicity concerns?

Chemical

EWG hazard score

Use in U.S. sunscreens

FDA 2019 proposed status

Skin penetration

Hormone disruption

Skin allergy

Other concerns

References

UV filters with higher toxicity concerns

Oxybenzone

8

Widespread

Insufficient data and concern for absorption through skin and hormone disruption

Detected in nearly every American; found in mothers’ milk; 1% to 9% skin penetration in lab studies

Weak estrogen, moderate anti-androgen; associated with altered birth weight in human studies

Relatively high rates of skin allergy

N/A

Janjua 2004, Janjua 2008, Sarveiya 2004, Gonzalez 2006, Rodriguez 2006,

Krause 2012,

Ghazipura 2017

Octinoxate
(Octyl methoxycinnamate)

6

Widespread

Insufficient data to determine safety – significant

data gaps

Found in mothers’ milk; less than 1% skin penetration in human and laboratory studies

Hormone-like activity; reproductive system, thyroid and behavioral alterations in animal studies

Moderate rates of skin allergy

N/A

Krause 2012, Sarveiya 2004, Rodriguez 2006, Klinubol 2008

UV filters with moderate toxicity concerns

Homosalate

4

Widespread

Insufficient data to determine safety – significant

data gaps

Found in mothers’ milk; skin penetration less than 1% in human and laboratory studies

Disrupts estrogen, androgen and progesterone

N/A

Toxic breakdown products

Krause 2012, Sarveiya 2004, SCCNFP 2006

Octisalate

4

Widespread; stabilizes avobenzone

Insufficient data to determine safety – significant

data gaps

Skin penetration in lab studies

N/A

Rarely reported skin allergy

N/A

Walters 1997, Shaw 2006, Singh 2007

Octocrylene

3

Widespread

Insufficient data to determine safety – significant

data gaps

Found in mothers’ milk; skin penetration in lab studies

N/A

Relatively high rates of skin allergy

N/A

Krause 2012, Bryden 2006, Hayden 2005

UV filters with lower toxicity concerns

Titanium dioxide

2 (topical use), 6 (powder or spray)

Widespread

Generally recognized

as safe and effective

No finding of skin penetration

No evidence

of hormone disruption

None

Inhalation concerns

Gamer 2006, Nohynek 2007, Wu 2009, Sadrieh 2010, Takeda 2009, Shimizu 2009, Park 2009, IARC 2006b

Zinc oxide

2 (topical use), 4 (powder or spray)

Widespread; excellent UVA protection

Generally recognized

as safe and effective

Less than 0.01% skin penetration in human volunteers

No evidence

of hormone disruption

None

Inhalation concerns

Gulson 2012, Sayes 2007, Nohynek 2007, SCCS 2012

Avobenzone

2

Widespread; best UVA protection of chemical filters

Insufficient data

Very limited skin penetration

No evidence

of hormone disruption

Breakdown product causes relatively high rates of skin allergy

Unstable in sunshine, must be mixed with stabilizers

Klinubol 2008, Bryden 2006, Hayden 2005, Montenegro 2008,

Nash 2014

Mexoryl SX

2

Uncommon; pending FDA approval; offers good, stable UVA protection

Insufficient data

Less than 0.16% skin penetration in human volunteers

No evidence

of hormone disruption

Skin allergy is rare

N/A

Benech-Kieffer 2003, Fourtanier 2008

Eight other ingredients approved in the U.S. are used rarely in sunscreens: dioxybenzone (benzophenone-8), cinoxate, ensulizole, meradimate (menthyl anthranilate), PABA, Padimate O, sulisobenzone (benzophenone-4) and trolamine salicylate. In 2019, FDA proposed that trolamine salicylate and PABA were unsafe for use and there was insufficient safety test data about other five.

Hormone disruption

Several common chemical filters appear to be endocrine disruptors. Many studies in animals and cells have shown that the chemicals affect reproduction and development by altering reproductive and thyroid hormones, although the evidence is mixed for some studies (Krause 2012). Animal studies report lower sperm counts and sperm abnormalities after oxybenzone and octinoxate exposure; delayed puberty after octinoxate exposure; and altered estrous cycling for female mice exposed to oxybenzone. Recently, Danish researchers reported that eight of 13 chemical sunscreen ingredients allowed in the U.S. affected calcium signaling of male sperm cells in laboratory tests, which the researchers suggest could reduce male fertility (Endocrine Society 2016).

Since most of the hazard data is generated from animal studies, it is difficult to determine the human health implications of exposure to a mix of hormone-disrupting ingredients in sunscreen.

In addition to the relationship between oxybenzone and testosterone levels in adolescents, preliminary investigations by a team of researchers at the National Institutes of Health and the State University of New York, Albany, suggest a link between higher concentrations of benzophenones and poorer reproductive success in men seeking assistance at a fertility clinic. Men with greater exposures to benzophenone-2 and/or 4-hydroxyoxybenzone had poorer sperm quality (Louis 2015) and reported that it took longer for their partners to conceive (Buck-Louis 2014). Female exposures to oxybenzone and related chemicals have been linked to increased risk of endometriosis (Kunisue 2012).

Mineral sunscreens

Mineral sunscreens are made with zinc oxide and titanium dioxide, usually in the form of nanoparticles. Evidence suggests that few if any zinc or titanium particles penetrate the skin to reach living tissues. So mineral sunscreens tend to rate better than chemical sunscreens in the EWG sunscreen database. However, it is important that manufacturers use forms of minerals coated with inert chemicals to reduce photoactivity. If they don’t, users might suffer skin damage, although to date no such problems have been reported.

The FDA should set guidelines and place restrictions on zinc and titanium in sunscreens to minimize the risks to sunscreen users and maximize these products’ sun protection. Our detailed analysis of nanoparticles in sunscreens is available here.

Inactive ingredients

The FDA must also look closely at the so-called inactive ingredients in sunscreens. These typically make up 50 to 70 percent of a sunscreen.

One ingredient in particular is a cause for concern: the preservative methylisothiazolinone, which is used alone or in mixtures with a related chemical preservative called methylchloroisothiazolinone. Lab studies indicate that methylisothiazolinone is a skin sensitizer or allergen. Over the past several years, physicians have reported serious cases of skin allergies, most notably in children exposed to methylisothiazolinone, by baby wipes and products meant to be left on the skin (Chang 2014). In a study published in 2014, researchers at Baylor University surveyed the ingredients in 152 children’s body care products labeled “hypoallergenic” and found methylisothiazolinone in 30 of them (Schlichte 2014). The American Contact Dermatitis Society named methylisothiazolinone its “allergen of the year” in 2013.

In 2015, researchers from 15 American and Canadian clinics reported an increase in methylisothiazolinone allergies in patients. The researchers concluded they had documented “the beginning of the epidemic of sensitivity to methyliosthiazolinones in North America” (Warshaw 2015). That methylisothiazolinone has become relatively common in sunscreen is a matter of concern because sunscreen users are likely to be exposed to significant concentrations of it. The products that contain it are intended to be applied to large portions of the body and reapplied often.

In March 2015, the European Scientific Committee on Consumer Safety concluded that no concentration of the chemical could be considered safe in leave-on cosmetic products (EU SCCS 2014). But methylisothiazolinone is still allowed in U.S. products. In 2014 the Cosmetics Ingredient Review, or CIR, expert panel – an independent body the American cosmetics industry pays to advise it on the safety of cosmetics ingredients – told the industry that methylisothiazolinone was safe for use in body care products as long as manufacturers came up with formulations that wouldn’t cause allergic reactions (CIR 2014). Since FDA has little legal power to regulate cosmetics ingredient safety, it has authorized the cosmetics industry to police itself through this panel, but it’s recommendations are not legally binding, and in several decades, it has declared only 12 ingredients or chemical groups to be unsafe (CIR 2017).

EWG recommends the FDA launch a thorough investigation of the safety of all sunscreen ingredients to ensure that none of them damage skin or cause other toxic effects.

 

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About the ratings

EWG provides information on sunscreen products from the published scientific literature, to supplement incomplete data available from companies and the government. The ratings indicate both efficacy and the relative level of concern posed by exposure to the ingredients in this product - not the product itself - compared to other sunscreens. The ratings reflect potential health hazards but do not account for the level of exposure or individual susceptibility, factors which determine actual health risks, if any. Methodology | Privacy Policy | Terms & Conditions

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