EpiLynx does not use phthalates or parabens or any of the below mentioned ingredients…. So why is FDA still silent about all of the below????

Breaking down the complex safety science of beauty.

By Tara Haelle

Makeup ingredients surrounding bottles

Between all the scary headlines about “toxic chemicals” in everyday products, and new items on the drugstore shelves marketed as XYZ-free, it’s reasonable to wonder whether the many ingredients in your cosmetics and personal care products are safe. Is the formaldehyde in nail polish safe? What about sulfates in shampoo and parabens in…well, almost everything?

It can feel overwhelming, and more than a little unsettling. To help you cut through the noise—and maybe trade your fear for some healthy skepticism—we’ve taken a look at some of the key ingredients you often hear about in your products and dug into the science for you.

If you want to better understand whether the chemicals in your cosmetics are safe, it helps to start with a big-picture look at how ingredients are studied and used.
The first thing to understand is that the US Food and Drug Administration does not regulate cosmetics the way it regulates food and drugs—that is, before they end up on the market. It’s more of a regulate-after-the-fact situation. The FDA expects the Cosmetic Ingredient Review (CIR), the industry’s safety and research board that publishes peer-reviewed studies on all ingredients used, to ensure the safety of all ingredients and products, so that whatever ends up in your makeup and skin-care products has been given the OK. If a health or medical problem is identified in a product that’s already on the market, that’s when the FDA may step in.

That’s not exactly encouraging to hear, which is why it’s great if you want to do your homework on ingredients and become a more informed consumer. But going down the Google hole can be a scary and confusing trip that’s likely to make you more afraid than ever. Here are some things to keep in mind.

For one, “chemical” doesn’t always mean “bad” and “natural” doesn’t always mean “good.” There are countless lab-made compounds that are perfectly safe for humans, and plenty of things in nature that can be harmful in one way or another.

There’s a crucial saying in science: The dose makes the poison. So something such as formaldehyde that sounds frightening may be no concern at all in the concentrations in your makeup. (After all, you own body makes formaldehyde.) But there’s no way to track all the chemicals from all sources in the environment you might be exposed to every day, so even if you’re laser-focused on what’s in your beauty and skin-care regimen, there’s no accounting for your overall accumulated exposure.

Many times, the decisions you make are going to require a little bit of digging, a little bit of trial and error, and a little bit of faith.
There’s a lot of research into what’s safe and what may not be, but the results often don’t lead to clear-cut answers like use this and avoid that. Many chemicals in use simply lack enough quality data for us to really understand how safe or risky they are. (And sometimes, the FDA may ban a substance only to have its replacement later prove to be no better, or worse.) Nothing in this world is 100 percent safe, Denis Sasseville, M.D., a professor of dermatology at McGill University in Montreal, tells SELF. (Remember that thing about the dose makes the poison? Consider this: You could end up in a coma from drinking too much water.) Any substance can cause allergic reactions, so an ingredient that’s safe for one person may cause unbearable skin irritation for you.

The bottom line? Some fears about cosmetic ingredients are legit. Others are exaggerated or simply nonexistent. And others…well, we’re still trying to figure that out. Given how loosely the cosmetics industry is regulated (though many are trying to change that), it’s all about making the most informed decisions you can. We’re here to help.

Aluminum
The primary concerns people have about aluminum, frequently used in antiperspirants, deodorants, lipsticks, and eye makeup (and found in lots of places, from soda cans to antacids), center on cancer and neurological problems. A few early studies suggested a possible link between aluminum and breast cancer, which led to more extensive research—and found no evidence that aluminum is carcinogenic. The only time aluminum has seemed to activate a few breast cancer cell types is in test tubes or Petri dishes, which means little without evidence in a real human (or any animal). (We took a deep dive into the questions about deodorant and breast cancer here.)

In terms of neurotoxicity, a 2013 study analyzed the content of 32 lipsticks and found all contained aluminum. A small percentage of them contained enough that people with the highest daily use of those lipsticks could theoretically take in enough aluminum to pose neurological risk—assuming they literally ate all the lipstick they applied. However, the Cosmetic Ingredient Review issued a report that same year on alumina and aluminum hydroxide in cosmetics, relying heavily on FDA toxicity data about those aluminum compounds. The report notes that only about 0.1 to 0.6 percent of aluminum in products gets absorbed orally, and it’s not absorbed at all through the skin. That report concludes that use of those aluminum compounds at current levels in cosmetics is safe, as do several additional CIR reports on other aluminum compounds in cosmetics.

Formaldehyde
Formaldehyde is a chemical people love to hate. It reminds us of dead things and cancer. It’s used in any number of products as a preservative, or released by other preservatives, such as quaternium-15, to prevent bacterial contamination. But some of its potential for harm is deeply misunderstood. First, only one type of formaldehyde molecule exists, whether naturally occurring or made in a lab, and it’s everywhere, even in the air we breathe. Our own bodies create formaldehyde when synthesizing amino acids and metabolizing medications. We all have about 2.5 micrograms of formaldehyde in each milliliter of our blood, and it’s in many foods, especially fruits and vegetables.

While formaldehyde is a known carcinogen, it’s only potentially cancer-causing when inhaled in large amounts, for long periods of time (think: embalmers and chemical factory workers), and we inhale far more formaldehyde released by trees (not to mention car exhaust) than we could ever get from using shampoo containing a formaldehyde-releasing preservative. It would take millions of showers in a single day to reach the levels prohibited by California’s famously strict Prop 65 law. Ob/gyns may caution their pregnant patients to switch to formaldehyde-free nail polish (and many expectant moms do), but it’s probably more of a concern for salon workers if they’re doing mani-pedis all day while pregnant.

Some products do release problematic levels of formaldehyde, but not personal care products. They’re cigarettes, motor vehicles, and certain household goods, such as particle board, pressed wood, carpet adhesives or some insulation materials, that may need time for off-gassing.

That said, some people have skin sensitivity to formaldehyde or other preservatives. An estimated 2-4 percent of dermatology visits are due to skin irritation from cosmetics ingredients, including formaldehyde—especially fragrances and preservatives. If a product irritates your skin, skip it. But don’t worry about getting cancer from it.

Fragrance
It’s tough to find a personal care product that doesn’t list “fragrance” among its ingredients. The mysterious f-word is in everything, it seems, and the problem is exactly that: its mystery. US laws do not require manufacturers to list ingredients used in fragrance (or “flavor”) because the formulations are usually proprietary and the government cannot compel companies to reveal their trade secrets. A fragrance may be made up of anywhere from dozens to hundreds of distinct chemicals.

Fragrances in cosmetics are a common source of irritation and allergic reaction. If your skin is sensitive—or if you just don’t know why some products seems to bother your skin—your dermatologist will likely suggest you try fragrance-free products (since you can’t tell from the label what ingredient in said fragrance might be the culprit). As far as any bigger health concerns, it’s hard to say conclusively, but there is at least some evidence of potentially harmful chemicals being hidden in certain fragrances. The Cosmetic Ingredient Review doesn’t raise such flags, but we do know that some fragrances contain phthalates, which come with their own host of unanswered health questions. (See the complex question of phthalates, below—and note that phthalates won’t appear on an ingredients list if it’s part of a fragrance.)

If you want to avoid products with fragrance, don’t rely on “unscented” labels. You need to explicitly look for “fragrance” in the ingredients list. Despite (allegedly) not having a scent, many unscented products still contain fragrance, perhaps to disguise whatever the natural smell of that product would be.

Lead
Many cosmetics contain trace amounts of lead because it’s commonly found in color additives, the sole cosmetics ingredient that explicitly requires FDA approval (not including coal tar hair dyes). Lead is a neurotoxin, among other harms. But in most—though not all—cosmetics, research suggests lead isn’t something to worry about. But cosmetics aren’t the only place lead is hiding, and exposure can be cumulative.

The lead in cosmetics is inorganic. Inorganic lead is far from harmless, but the body absorbs far less of it than of organic lead. The FDA analyzed 400 lipsticks—results from the 2007 and 2010 surveys here—and found they all contained inorganic lead at an average 1 part per million (ppm). The agency’s analysis of hundreds other cosmetics, including eyeshadows and blushes, found levels ranging from 7-14 ppm, but 99 percent of products had levels below 10 ppm, which the FDA then set as the maximum allowed.

Even if you accidentally lick off some lipstick or a eat burger your lipstick rubbed off on, the FDA says only a tiny amount is likely to get into your bloodstream. Still, there’s reason to be concerned about the health effects of environmental lead exposure from all sources, and some experts do worry that using lipstick with even trace amounts of lead regularly over long periods could be a notable contributor.

There is lead in some “progressive” hair dyes, that get darker over time, so the FDA requires the label carry a warning with instructions to avoid applying the dyes to broken skin and only use them on scalps, not mustaches, eyelashes, eyebrows or other body hair.

One product type to avoid because of high lead content is any eye makeup containing kohl. Though illegal in the U.S., kohl products sometimes arrive from overseas and contain enough lead to potentially cause lead poisoning, resulting in anemia, seizures, brain damage, kidney damage, or, with enough exposure, possibly even causing coma or death in children. Pregnant woman are also highly at risk with with this type of exposure.

Mineral Oil and Petroleum
Hundreds of oils are used in different cosmetics, including oils from minerals, seeds, vegetables, castor, fruits, nuts, grains, flowers, mink and other organic materials. Each has different chemical properties—and therefore different potential effects—and many are then combined with various other chemical compounds. People worry about mineral oil, used in some lotions to help keep moisture in the skin, and other petroleum distillates produced from the process of refining crude oil. Untreated or lightly treated mineral oil is a known carcinogen, but highly refined cosmetic grade mineral oils (and other liquids distilled from petroleum) used in beauty products are not dangerous. In fact, they’re safe enough that physician researchers recommend both mineral oil and petroleum jelly as safe, effective treatments for babies’ diaper rash. The biggest potential problem with these products is whether they’ll clog your pores (probably not). Generally speaking, the human health concerns with oils would be allergic reactions to the source, such as nut, wheat, corn or fruit allergies, but that varies by person.

The bigger question about the use of various oils in cosmetics is their environmental and social impact. While sunflower oil, for example, is typically manufactured ethically and sustainably, it’s hard to get more destructive than palm oil. The clearing of land for palm plantations has contributed to deforestation, climate change, theft of indigenous peoples’ lands, violation of human rights, animal cruelty, and habitat destruction, particularly for orangutans and the Sumatran tiger and rhinoceros.

Parabens
Parabens are a group of organic compounds used as preservatives in a wide range of products: shampoos and conditioners, makeup, moisturizers, shaving products, and others. People’s concerns about them primarily center on the way they mimic estrogens and can bind to the body’s estrogen receptors, leading to concerns about their effects on reproductive health and breast cancer. It’s true that they can act like estrogen in your body (the scientific community has its eye on endocrine disruptors and their potential for negative health effects), but, to put that in context, parabens bind with 10,000 to 1 million times less strength than the hormone estradiol used in birth control pills.

There are lots of different parabens. You’ve got the short-chain methyl- and ethylparabens, which are most commonly found in personal care products and have lower estrogenic activity than their longer-chain counterparts, such as propylparaben and butylparaben. Methyl- and ethylparabens are used most often in products, but propyl- and butylparabens are also used. The CIR has found no evidence that the amounts of these short- and long-chain parabens as used currently in cosmetics pose health risks. Regulatory bodies in the EU, where ingredients rules are typically more stringent, allow them as well, with restrictions. There are five even longer-chain parabens that are banned in Europe, two of which aren’t used in the US and three of which are under safety review as of this April.

Still, increased estrogen levels from any source may increase breast cancer risk, and scientists studying breast tumors have found tiny amounts of the same parabens used in topical products, such as shaving cream, body creams, and deodorant (many major brands no longer contain parabens). But they also found parabens in non-cancerous, healthy tissue. So it’s not clear what the findings mean, whether the parabens came from body products or another source, or whether they’re related to the cancer at all. Some research has shown that skin cells break down any parabens that enter through the skin.

Why include parabens if there’s even a hint that they could do harm? They are added to products to make them safer by preventing bacterial or fungal contamination that could cause illness or infection, and parabens are considered among the safest preservatives available.

“Any time there is a product to be in contact with the skin and it contains water, it has to contain a preservative,” Dr. Sasseville says. “Otherwise, very soon, it gets contaminated with mold and bacteria, and this may harm the customer.” If the bacteria Pseudomonas, for example, gets in your mascara and then in your eye, you could go blind, he says.

As with anything, it’s about balancing risks and benefits. Bacterial and fungal infections are a more likely and direct threat than developing a hormone-related cancer, and only so many preservatives exist. If companies have fewer options, then the same preservatives get used more often, increasing people’s exposure to each of them. As an industry chemist whose job focuses on safety told me, using a wider range of preservatives at lower levels limits overall exposure to each chemical. And if you take parabens out of a product, you have to put something else in to do its job. “Whenever I see a product that’s paraben-free, it means they must have used something else to preserve it,” says Dr. Sasseville, emphasizing that he is a dermatologist, not an endocrinologist. From his perspective as someone who treats skin reactions, the replacement is often more likely to cause problems.

Phthalates
This one is particularly complicated. Phthalates are in a wide range of products, from children’s toys to food products to medical devices to medication pill coatings to cosmetics. They’re primarily used as plasticizers to keep plastic from becoming brittle and breaking, and are also used in some of the fragrances in products like lotions and shampoos. There are lots of different types of phthalates, and we’re exposed to them a lot. Certain ones have known health hazards—di(2-ethylhexyl) phthalate, for example, is a carcinogen that may interfere with the reproductive system—but those aren’t used in cosmetics.

So what about the ones that are in your beauty products? Well, depending on whom you ask, you’re going to get very different answers. Some experts worry that the constant exposure we get to phthalates—not just from cosmetics, but from all around us—can be harmful, pointing to research that says certain phthalates can act as endocrine disruptors in rodents and possibly in humans. Endocrine disruptors mess with hormones, which can cause reproductive abnormalities or developmental problems. But when you look at studies, it can be very hard to translate the findings into useful information about what phthalates in your personal care products might or might not be doing to you. For one thing, rats are not humans, so you can’t assume that everything that happens in a rodent model will hold true for humans (and vice versa). It’s also very difficult to isolate the effects of one particular phthalate when we are exposed to a broad range of them, many which aren’t found in cosmetics—or at least aren’t anymore.

Due to rising concerns and unanswered questions, phthalates are becoming less common in personal care products, and many phthalates are disappearing from the market for all kinds of uses, says Hans Plugge, a toxicologist in Bethesda, Maryland. The FDA started monitoring phthalates in cosmetics in 2004 and found that their use in cosmetics had “decreased considerably” by the time of a subsequent survey six years later (see 2010 results here).

There’s one phthalate still commonly found some personal care products: diethyl phthalate (DEP), used to dissolve and fix fragrance. But you may not know it’s there, since companies aren’t required to divulge on their labels what’s in their fragrances. (DEP is listed if not in a fragrance.)

Other than DEP, there’s really only one other phthalate you’re likely to encounter in cosmetics, and that’s dibutyl phthalate (DBP), which is still used in some nail polishes. Neither is classified as a carcinogen. There is minimal data in animal studies using high doses or lifetime exposure that suggest it can cause reproductive and developmental problems, but there isn’t evidence of this in humans.

Another confounding factor is that the phthalates in some plastic bottles may leach into the product inside. This is unfortunately hard to avoid. The leached amounts would be very small, but it’s not known whether they have an effect.

As with many any ingredients, phthalates could cause allergic reactions in some, but even those are rare at the levels found in cosmetics.

The frustrating truth is that, for now, it’s really hard to know definitively say whether or not phthalates cause harm, and if so, how much exposure is safe, and whether exposure to different types of phthalates simultaneously and over time poses any health risks. There’s not much good human data to support fears about the chemicals—or enough to dismiss them entirely.

Sulfates (SLS and SLES)
The term “sulfates” is broad, referring to salts that result from a reaction involving sulfuric acid, and the CIR database lists more than 100 sulfates that may exist in products. But when people express concern about sulfates in their products, it generally refers to two compounds in shampoos, soaps, toothpastes, and other personal hygiene products (particularly those that suds up): sodium lauryl sulfate (SLS) and sodium laureth sulfate (SLES).

The FDA actually allows SLS in food, and it’s a common household cleaning ingredient (and considered safe). It definitely does not cause cancer; in fact, the American Cancer Society went out of its way to debunk that concern way back in 1998.

According to research in household cleaners, SLS concentrations above 2 percent can cause mild skin irritation, after 24 hours of exposure, which is a lot longer than you’d be scrubbing your tub—or sudsing up in it. Beyond that, extensive testing in animals and humans shows no effects from chronic use and only the temporary skin issues in some people from short-term exposures. SLES similarly can irritate the skin or eyes but is even milder than SLS (and can be made milder still by adding other compounds).

So what’s the fuss about? Sulfates’ drawbacks are also their strength: They’re REALLY good at cleaning, sometimes too good. They cause the foaming in soap products and strip away dirt by attracting both oil and water. The dirt sticks to the oil, which stays with the water and washes away. The problem is that sulfates in soaps and shampoos may strip too much of your skin or hair’s natural oils and proteins, thereby drying you out. Washing your hair less frequently can help with that, or use sulfate-free shampoos, which are milder.

Talc
Talc, a mineral used in a broad range of cosmetics, including eyeshadow, blush, and pressed powders, is often found near mines for asbestos, which can cause mesothelioma and other cancers. As a result, talc can be contaminated with asbestos and therefore be carcinogenic, a worrisome fact that’s well known—which is why the Occupational Safety & Health Administration lists talc with asbestos and talc without asbestos as two different substances, and only the latter is used in cosmetics.

You’ve probably heard news about women alleging that asbestos-contaminated talc in Johnson & Johnson baby powder caused their ovarian cancer. Whether J&J products now or ever contained talc contaminated by asbestos is being hashed out in the courts—more than 5,000 lawsuits are currently underway. Some plaintiffs have won big settlements; some verdicts in favor of plaintiffs have been overturned, and other cases were dismissed. At least some J&J documents suggest their products may have had trace amounts of asbestos, possibly enough to pose a cancer risk. The company stands by the safety of its products.

Scientists are also investigating whether talc without asbestos might be carcinogenic as well; the minerals have similar properties. Those findings, as the American Cancer Society notes, are mixed, particularly regarding the possible risk of ovarian cancer following long-term use of talcum powder near the genitals. Many doctors are unconvinced of the link, but tell their patients that cornstarch is a good substitute for body powder, if avoiding talc will give them peace of mind.

The possibility that talc may have weak carcinogenic potential has not been completely ruled out by researchers, nor has the possibility that some products may contain talc contaminated by asbestos. FDA testing of 34 cosmetic products found no asbestos in them but acknowledged its findings with such a small sample were “informative,” not conclusive. The Cosmetic Ingredient Review Expert Panel studied the use of talc in cosmetics and concluded that “talc is safe for use in cosmetics in the present practices of use and concentration” (even products that are 100 percent talc), but cautions users not to apply it to broken skin.

Triclosan
Originally developed as a pesticide in the 1960s, triclosan is an antibacterial and antifungal agent used in hundreds of consumer products—including some shampoos, conditioners, lotions, deodorants, body washes, fluoride toothpastes, makeup, and aftershave—primarily to kill bacteria. It’s probably most known as an ingredient once used in antibacterial soaps, but since studies indicate it’s no better at killing germs and preventing illness than plain old soap and water, the FDA barred its use in soaps and over-the-counter healthcare antiseptics in 2016.

The FDA’s ruling also took into account that manufacturers didn’t provide ample data on the safety of long-term triclosan exposure. Some short-term studies suggest that high doses of triclosan in animals mess with their thyroid hormones, but it’s not clear what or if that means anything for humans. Ongoing studies are investigating whether chronic exposure can increase skin cancer risk, though short-term animal studies found no link. Triclosan might increase people’s sensitivity to allergies, but studies aren’t conclusive.

Finally, using triclosan might help bacteria build up resistance to it. The evidence conflicts, but some studies show bacteria becoming less susceptible to triclosan over time. That’s not necessarily a health concern for individuals using products with it, but increasing resistance to triclosan could contribute to the overall public health problem of antibiotic resistance.

Yet it is still used as an antibacterial agent in many other products, such as some foundations and mascaras—and is even added to some fluoride toothpastes, since there is evidence it reduces risk of gingivitis and possibly some tooth decay (but only a tiny amount). Is it unsafe in those products? We don’t really know. There isn’t evidence showing it’s definitely unsafe in the small doses you’d be exposed to in one product. But it might depend on how many products you use that contain it and how often you use them. The Mayo Clinic’s answer to whether we should avoid products containing triclosan: “probably.”