FDA Admits Most Sunscreens Are Probably Unsafe

FDA Admits Most Sunscreens Are Probably Unsafe

First off, let me make it very clear that sunscreen is widely overused. There are some circumstances where it is wise and appropriate to use but those cases are few and far between. For the most part, you just need to avoid the sunscreen and rely on sensible sun exposure. Get out of the sun or wear clothing the moment your skin starts to turn light pink.

Having laid that foundation, the U.S. Food and Drug Administration (FDA) recently proposed new regulations1 to “make sure sunscreens are safe and effective.” 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 been deemed safe for human use by the FDA.

Yeah, I know what you’re likely thinking. You can trust the FDA about as far as you can throw them. It’s a captured agency and essentially controlled by the very industry it is seeking to regulate. However, there appear to be no vested interests here and I believe they got it right this time.

In its proposal, 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.

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 latter, 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. Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research said:2

“It is important that, as this rulemaking effort moves forward and the FDA gathers additional scientific information, given the recognized public health benefits of sunscreen use, consumers continue to use sunscreen in conjunction with other sun-protection measures.

To help make sure this effort is successful, the FDA is looking to industry to gather the data needed to help ensure that products marketed to offer protection from the sun’s effects are safe and deliver on these promises.”

Evidence of Toxicity Exists For Several Sunscreen Ingredients

One of the 12 active sunscreen ingredients the FDA claims to be unsure about is oxybenzone, found in an estimated 70 percent of sunscreens. This, despite studies showing this chemical acts as an endocrine disruptor and has been linked to reduced sperm count3 in men and endometriosis4 in women.

Research by the Centers for Disease Control and Prevention shows 96 percent of the U.S. population has oxybenzone in their bodies, which is a testament to just how much sunscreen people are using.

Indeed, daily use of sunscreen is one of the reasons cited by the FDA for the need to update safety regulations. People are using far more sunscreen these days, so exposure to potentially hazardous ingredients is of far greater concern than in decades past.

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.5 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.6,7

Many Sunscreen Ingredients Have Endocrine Disrupting Effects

Oxybenzone isn’t the only endocrine disruptor though. At least eight other active sunscreen ingredients are suspected of having endocrine disrupting effects.8,9

According to a recent Danish study,10 13 of 29 sunscreen chemicals (45 percent) allowed in the U.S. and/or European Union 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, eight are approved for use in the U.S. These include:

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

These chemicals can also be found in makeup, moisturizers and lip balms with sunscreen protection. “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.11

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.

Some Sunscreen Ingredients Are Also Neurotoxic

Researchers have also warned that some sunscreen ingredients are neurotoxic, posing a hazard to brain health. The authors of this study noted that since sunscreens need to be applied in significant amounts all over the body, calculations suggest the total amount of a given compound being absorbed from a single application could be as high as 200 milligrams.12

According to the above-referenced study, other studies also show these chemicals are found in blood, urine and breast milk following application, in some cases within as little as two hours. According to the authors:

“[W]hile sunscreens have been effective in protecting against a variety of UV-related pathologies … growing popularity and thus, possibility for exposure questions their safety in environment and human health …

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.”

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

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

The authors also stress that simultaneous application of insect repellents such as DEET enhances the penetration of the compounds, thereby multiplying their potential toxicity.

Avoid Sunscreens With Nanoparticles

Most nanoscale particles (microscopic particles measuring less than 100 nanometers)13 found in American sunscreens are either titanium dioxide or zinc oxide.14 While these two are the only ingredients known to be safe, this safety does not extend to nano-sized versions.

We have used both of these safe ingredients in our Sunscreen SPF 50 for nearly 10 years. This is likely why our sunscreen was rated No. 1 two years ago by the Environmental Working Group.



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