FDA Study: Toxic Sunscreen Chemicals Absorbed Into Blood

While there are instances where sunscreen may be prudent, these products are widely overused and contribute to widespread vitamin D deficiency.

In my view, sunscreen is rarely needed, provided you’re following sensible sun exposure guidelines to prevent burning. Simply get out of the sun or wear clothing the moment your skin starts to turn light pink.

That said, conventional guidance by the American Academy of Dermatology1 stresses the use of sunscreen, not only when lying on the beach but every single day, regardless of weather or skin pigmentation. Aside from promoting vitamin D deficiency, which has a long list of health consequences, sunscreen use may also be a source of toxic exposure.

Pilot Study Confirms Your Body Absorbs Toxins From Sunscreens

A pilot study2,3,4,5 by the U.S. Food and Drug Administration (FDA) shows four commonly used active ingredients in sunscreen are absorbed into your blood at levels that could potentially pose health risks. The four active ingredients looked in this study were avobenzone, oxybenzone, octocrylene and ecamsule.

Twenty-four participants were asked to apply 2 milligrams (mg) of sunscreen per square centimeter over 75% of their body, using either one of two sprays, a lotion or a cream. This amount equates to the maximum recommended dose recommended by most makers of sunscreen.

A total of 30 blood samples were collected from each participant over seven days of application. The geometric mean maximum plasma concentrations were as follows for each of the chemicals:6

  • Avobenzone — 4 nanograms per milliliter (ng/mL) for spray No.1; 3.4 ng/mL for spray No. 2; 4.3 ng/mL for lotion and 1.8 ng/mL for the cream
  • Oxybenzone — 209.6 ng/mL for spray No. 1; 194.9 ng/mL for spray No. 2, and 169.3 ng/mL for lotion
  • Octocrylene, — 2.9 ng/mL for spray No. 1; 7.8 ng/mL for spray No. 2; 5.7 ng/mL for lotion, and 5.7 ng/mL for cream
  • Ecamsule — 1.5 ng/mL for cream

According to the authors:7

“Systemic concentrations greater than 0.5 ng/mL were reached for all 4 products after 4 applications on day 1. The most common adverse event was rash, which developed in 1 participant with each sunscreen.

“In this preliminary study involving healthy volunteers, application of 4 commercially available sunscreens under maximal use conditions resulted in plasma concentrations that exceeded the threshold established by the FDA for potentially waiving some nonclinical toxicology studies for sunscreens …

“FDA has provided guidance that sunscreen active ingredients with systemic absorption greater than 0.5 ng/mL or with safety concerns should undergo nonclinical toxicology assessment including systemic carcinogenicity and additional developmental and reproductive studies.”

Continue Using Sunscreen, FDA Says, Ignoring Potential Health Risks of Oxybenzone

While it comes as no surprise that toxic chemicals are being absorbed into your blood when applied to your skin, what’s shocking is the FDA’s guidance in light of the results — continue using sunscreen!8

This, despite the fact that all four chemicals were found to enter the bloodstream at levels above the presumed “safe” level after a single day of application, and remained in the system for at least 24 hours after last use. Just what might the ramifications be if you’re using them every single day, year-round?

Research9 by the U.S. Centers for Disease Control and Prevention (CDC) published in 2008 found 96.8% of the 2,517 urine samples collected as part of the 2003-2004 National Health and Nutrition Examination Survey had detectable levels of oxybenzone, which is a testament to just how much sunscreen people are using. And this data is 15 years old. It is likely far worse now.

Dr. David Strauss, director of the division of applied regulatory science at the FDA’s Center for Drug Evaluation Research and co-author of the FDA pilot study, told Time,10

“This supports the need for further studies to understand the clinical significance of this. We really have a paucity of data on whether there are adverse health effects of these ingredients or not.”

Dermatologist and spokesman for the American Academy of Dermatology, Dr. David Leffell, echoed the FDA’s recommendation, telling CNN Health,11

“Studies need to be performed to evaluate this finding and determine whether there are true medical implications to absorption of certain ingredients. [In the meantime, people should] continue to be aggressive about sun protection.”

The Hazards of Oxybenzone

According to the Environmental Working Group,12 oxybenzone

“has been linked to allergies, hormone disruption, and cell damage. A companion study published just one day earlier revealed that this chemical is linked to low birth weight in baby girls whose mothers are exposed during pregnancy. Oxybenzone is also a penetration enhancer, a chemical that helps other chemicals penetrate the skin.”

Research has also linked oxybenzone to “significantly lower” testosterone levels in adolescent boys,13 and reduced sperm count14 and altered hormone levels in men (specifically testosterone, estradiol and inhibin B).15 In women, the chemical has been linked to endometriosis,16 shorter pregnancies and lower male birth weights.17

Oxybenzone is also lethal to certain sea creatures, including horseshoe crab eggs, and researchers warn the widespread use of oxybenzone-containing sunscreens pose a serious threat to coral reefs and sea life.18

This effect is what prompted Hawaiian lawmakers to ban the sale of sunscreens containing oxybenzone and octinoxate, both of which have been linked to severe coral damage.19,20
How FDA Established Safety Threshold for Sunscreen Chemicals

As mentioned, 0.5 ng/mL is the threshold for systemic concentration via absorption set by the FDA, below which companies do not need to perform certain toxicology studies. Here’s how the FDA set that threshold:21

“The 0.5-ng/mL threshold is based on the principle that the level would approximate the highest plasma level below which the carcinogenic risk of any unknown compound would be less than 1 in 100 000 after a single dose. This Threshold of Toxicological Concern (TTC) concept was first adopted by FDA in the regulation of food packaging substances that can migrate into food.

“The threshold value is also consistent with the TTC applied to pharmaceutical drug substance impurities in the International Council for Harmonisation ‘Guidance for Industry: M7 (R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.’

“That document recommends a TTC of 1.5 μg/d, when appropriate, which was translated to 0.5 ng/mL for sunscreen active ingredients, assuming a circulating plasma volume of approximately 3 L.

“Application of this concept was considered acceptable during the determination of the ‘generally recognized as safe and effective’ status of sunscreen active ingredients because such ingredients will be supported by extensive human use and absence of other pharmacologic or toxicologic signals from the nonclinical assessment recommended in the FDA sunscreen guidance.”

It’s worth noting that the 0.5 ng/mL threshold originates from regulation of chemicals that can migrate from food packaging into food, which means they would be consumed. Chemicals applied to your skin frequently go straight into your bloodstream, bypassing your gastrointestinal system, and hence may pose a different and potentially greater threat to health than ingested chemicals.

In short, there’s no telling whether the 0.5 ng/mL threshold is really appropriate for these four (and other) sunscreen chemicals. Only further study can shed light on that.

But rather than taking a precautionary approach and instructing individuals to use sunscreens known to be safe (non-nano-sized zinc oxide and titanium dioxide), the FDA simply says,

“These results do not indicate that individuals should refrain from the use of sunscreen.”22

From my perspective, the results are a warning flag indicating you indeed should refrain from using these products as they have well documented health hazards!
Irrational Sunscreen Recommendations Issued by Consumer Reports

Consumer Reports has issued equally irrational recommendations. Less than a week before publishing the results of the FDA’s pilot study,23 in which they noted that the “results strengthen FDA’s call for more information on sunscreen safety,” Consumer Reports issued its annual Best Sunscreens report.24 Remarkably, all of Consumer Reports’ recommended sunscreens contain oxybenzone.

Topping their lotion and spray lists:

  • Best lotion — La Roche-Posay Anthelios 60 Melt-in Sunscreen Milk (which the EWG Guide to Sunscreens,25 incidentally, rates among the worst, noting its active ingredient, oxybenzone, poses a moderate health concern)
  • Best spray — Trader Joe’s SPF 50+ Sunscreen, which contains both oxybenzone and avobenzone

Don Huber, director of product safety at Consumer Reports, commented on the potential concerns people might have about oxybenzone saying,

“While we recognize there are concerns with oxybenzone, we know that sunscreen is a critical part of an overall sun protection plan. It’s proven to prevent sunburn, and can lower your risk of skin cancer and reduce skin aging, and our testing is based on a product’s ability to filter UV rays.”

The oxybenzone-free sunscreens recommended by Consumer Reports are Walgreens Hydrating SPF 50 lotion26 and Hawaiian Tropic Sheer Touch Lotion SPF 50,27 both of which contain avobenzone instead.

However, no studies have been done to confirm whether avobenzone is actually a safer choice. According to a recent Danish study,28 13 of 29 sunscreen chemicals allowed in the U.S. and/or European Union have the ability to reduce male fertility, and avobenzone is one of them.

New Sunscreen Regulations Proposed by FDA

The FDA recently proposed new regulations30 to “make sure sunscreens are safe and effective” in light of daily use. The public comment period ends May 28, 2019.31 If enacted, this could have a transformative effect on the sunscreen industry as a whole.

Importantly, as I’ve noted on a number of occasions, of all the active sunscreen ingredients used in products on the U.S. market, only two — non-nano-sized zinc oxide and titanium dioxide —  have actually been deemed safe for human use by the FDA.

In its proposed rule, the FDA admits it does not have enough scientific data to draw any conclusions about the safety of 12 of the 16 active sunscreen ingredients on its list, and asks industry to help in providing more data to perform a “rigorous assessment” of all active ingredients on the market. Its pilot study was part of this current push to learn more about these ingredients.

Two of the 16 ingredients, PABA and trolamine salicylate, have been deemed unsafe, or not generally recognized as safe (GRAS), and are not currently in use, according to the FDA.

The proposal also includes broad updates to labeling requirements, as well as SPF-related changes. For the changes, FDA wants sunscreens with an SPF of 15 or higher to provide broad spectrum protection against both UVA and UVB rays, not just UVB as is currently the case.
Many Sunscreen Ingredients Have Endocrine Disrupting Effects

In addition to oxybenzone, at least eight other active sunscreen ingredients are suspected of having endocrine disrupting effects.32,33 As mentioned above, recent Danish research34 has highlighted the risk to male fertility by 13 of 29 sunscreen chemicals allowed in the U.S. and/or European Union.

The researchers found these chemicals have the ability to reduce male fertility by affecting calcium signaling in sperm, in part by exerting a progesterone-like effect. Of those 13 chemicals, the following eight are approved for use in the U.S.:

  • Avobenzone
  • Homosalate
  • Meradimate
  • Octisalate (also known as octyl salicylate)
  • Octinoxate (octyl methoxycinnamate)
  • Octocrylene
  • Oxybenzone (also called benzophenone-3)
  • Padimate O

“These results are of concern and might explain in part why unexplained infertility is so prevalent,” senior investigator, Niels Skakkebaek, professor at the University of Copenhagen in Denmark and a researcher at the Copenhagen University Hospital, said.35

Many sunscreens also contain vitamin A and/or its derivatives, retinol and retinyl palmitate, which have been linked to an increased risk of skin cancer by increasing the speed at which malignant cells develop and spread.

Oxybenzone and Other Sunscreen Ingredients Are Also Neurotoxic

Research36 published in Toxicology Reports in 2017 also warn that some sunscreen ingredients — including oxybenzone — are neurotoxic (toxic to your brain). The authors noted that:

  • Since sunscreens need to be applied in significant amounts all over the body, calculations — assuming a maximum skin penetration of up to 5% — suggest the total amount of a given compound being absorbed from a single application could be as high as 200 milligrams (mg) or 2.56 mg per kilo of bodyweight
  • Simultaneous application of insect repellents such as DEET enhances the penetration of the compounds, thereby multiplying their potential toxicity
  • Sunscreen chemicals are found in blood, urine and breast milk following application, in some cases within as little as two hours

Sunscreen ingredients found to have neurotoxic effects in this study included:37

  • Octyl methoxycinnamate — Found to decrease motor activity in female rats and alter the release of a number of different neurotransmitters
  • Benzophenone-3 (oxybenzone) — Decreases cell viability of neurons, and upregulates estrogenic-related genes in male animals
  • 4-methylbenzylidene camphor — Decreased cell viability and impaired neuronal development in lab animals
  • 3-benzylidene camphor
  • Octocrylene — Impaired expression of genes related to brain development and brain metabolism

According to the researchers:38

“The endocrine disruptive and developmental toxicity of many organic UV filters in experimental models is well established; these filters seem to be associated with altered estrogen, androgen and progesterone activity, reproductive and developmental toxicity and impaired functioning of the thyroid, liver or kidneys …

“Since many of UV filters were shown to cross the blood-brain barrier, the risk for neurotoxicity also occurs … [S]ince it is known that other chemicals classified as endocrine disruptors can impair neuronal transmission, synaptic plasticity and produce neurotoxic effects, chemical filters might potentially produce similar effect.”

Considering the endocrine disrupting and neurotoxic effects of oxybenzone, its high absorbability, and the availability of safe sunscreens (those containing non-nano-sized zinc oxide and titanium dioxide), it seems rather irrational and downright irresponsible of FDA, the American Academy of Dermatology and Consumer Reports to urge people to continue slathering themselves and their children with oxybenzone-containing sunscreen on a daily basis.

How to Choose a Safer Sunscreen

When selecting a sunscreen, remember there really are only two known safe sunscreen ingredients — zinc oxide and titanium dioxide39 — and they must not be nano-sized.

Your safest choice is a lotion or cream with zinc oxide, as it is stable in sunlight and provides the best protection from UVA rays.40 Your next best option is titanium dioxide. Just make sure the product does not contain nano-sized particles and protects against both UVA and UVB rays.

Also keep in mind that SPF protects only from UVB rays (although if the FDA’s proposed rules are implemented, any SPF at or above 15 must protect against both UVA and UVB), which are the rays within the ultraviolet spectrum that allow your skin to produce vitamin D.

The most dangerous rays, in terms of causing skin damage and cancer, are the UVA rays. Avoid sunscreens with an SPF above 50. While not intrinsically harmful, the higher SPF tends to provide a false sense of security, encouraging you to stay in the sun longer than you should.

Moreover, higher SPF typically does not provide much greater protection. In fact, research suggests people using high-SPF sunscreens get the same or similar exposure to UV rays as those using lower-SPF products.

What’s more, a recent analysis41 by Consumer Reports found many sunscreens are far less effective than claimed on the label; 32 of the 82 products evaluated for 2019 offered less than half the protection promised by their stated SPF. Consumer Reports said they’d seen “a similar pattern in previous years’ sunscreen tests.”

Sensible Sun Exposure Is Good for Your Health and Longevity

I recommend spending time in the sun regularly — ideally daily. Sunshine offers substantial health benefits, provided you take a few simple precautions to protect yourself from overexposure. Here are my top five sensible sunning tips:

• Give your body a chance to produce vitamin D before you apply sunscreen. Expose large amounts of your skin (at least 40 percent of your body) to sunlight for short periods daily.

Vitamin D is involved in the biochemical function of nearly every cell and tissue in your body, including your immune system. When you’re deficient in vitamin D, your health can deteriorate in a variety of important ways, because your cells require the active form of vitamin D to gain access to the genetic blueprints stored inside the cell.

Research42 published in the International Journal of Environmental Research and Public Health in December 2018 called for an immediate revision of public health recommendations, noting that “nonburning UV exposure is a health benefit and — in moderation — should be recommended as such.”

The authors warn that the public has been misled and misinformed about the health ramifications of sun avoidance, as there are significant hazards associated with vitamin D deficiency, including a heightened risk of heart disease and several cancers, especially internal cancers but also skin cancer.43

This paper also points out that an estimated 12% of all U.S. deaths may be linked to inadequate sun exposure, and that sun avoidance is as potent a risk factor for death as smoking.

• Stay out just long enough for your skin to turn the very lightest shade of pink. Shield your face from the sun using a safe sunscreen or hat, as your facial skin is thin and more prone to sun damage, such as premature wrinkling.

When you’ll be in the sun for longer periods, cover up with clothing, a hat or shade (either natural or shade you create using an umbrella). A safe sunscreen can be applied after you’ve optimized your skin’s daily vitamin D production, although clothing is your safest option to prevent burning and skin damage.

• Keep in mind that in order for sunscreen to be effective, you must apply large amounts over all exposed areas of your skin. This means the product should not trigger skin allergies and must provide good protection against UVA and UVB radiation. It also should not be absorbed into your skin, as the most effective sunscreen acts as a topical barrier.

• Consider the use of an “internal sunscreen” like astaxanthin to gain additional sun protection.44,45,46,47 In one study,48  subjects who took 4 milligrams of astaxanthin per day for two weeks showed a significant increase in the amount of time necessary for UV radiation to redden their skin.

On average, approximately 20% more energy was needed for skin reddening to occur. Astaxanthin can also be applied topically, which is why it’s now being incorporated into a number of topical sunscreen products.

Consuming a healthy diet full of natural antioxidants is another highly useful strategy to help avoid sun damage. Fresh, raw, unprocessed foods deliver the nutrients that your body needs to maintain a healthy balance of omega-6 and animal-based DHA omega-3 oils in your skin, which are your first lines of defense against sunburn.

Vegetables also provide your body with an abundance of powerful antioxidants that will help you fight the free radicals caused by sun damage that can lead to burns and cancer.

By Dr. Joseph Mercola, excerpts. You can read the entire article here.