Just as the weather turns warmer, we learn there’s something new to worry about when we reach for that tube of sunscreen: its ingredients.

In February, the Food and Drug Administration announced potential changes for the sunscreen monograph — that is, the organization’s rules for SPF products, which are considered over-the-counter drugs.

As part of the proposed revisions, which could go into effect as early as November, the FDA is asking for additional research data on 12 ingredients, including octinoxate, octisalate and oxybenzone. Chances are, at least one of those chemicals is in the sunscreen that’s now in your makeup case or beach bag.

The FDA isn’t saying that these chemicals are unsafe. “We just don’t have enough information to make a determination,” said Dr. Theresa Michele, the director of the FDA Division of Nonprescription Drug Products. “When we look at safety, you have to remember that nothing is completely safe.” Michele said the FDA makes a determination of risk and benefit for every drug it evaluates, “and that’s what we’re looking at here.”

Oxybenzone, for example, has been shown in some studies to disrupt hormones; it is also absorbed by the body more intensely than previously believed.

“The chemical can get into our bodies more readily, and more of it,” said Nneka Leiba, the director of healthy living science at Environmental Working Group, a research and advocacy organization in Washington. “They are concerned, as are we, at that systemic absorption.”


Some other chemicals have been linked to endocrine disruption as well, but more important, and this is what the FDA emphasizes, there are simply not enough studies on them. Oxybenzone also has a high rate of allergic reaction and irritation, and some researchers think there may be a link between the hormonal disruption it can cause and cancer.

Oxybenzone and octinoxate have also been shown to damage the coral layer of the ocean. The unregulated term “reef safe” has become a way for brands and retailers to designate products without those ingredients. Last year, Hawaii passed a bill to ban the sale of sunscreens with them; Key West, Florida, recently did the same. That legislation goes into effect on Jan. 1, 2021.

So, what ingredients are considered to be safe?

The FDA proposes that two ingredients, zinc oxide and titanium dioxide, be considered GRASE, the acronym for “generally recognized as safe and effective,” at certain concentrations. They are mineral blockers and sit on top of the skin to physically block the sun’s rays instead of protecting skin through a chemical reaction to light.

Some new products are based on these ingredients, like REN Clean Skincare Clean Screen Mineral SPF 30 Face Sunscreen, which uses zinc oxide to deliver sun protection, and Naturally Serious Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30, which was recently released.

Other mineral sunscreens on the market include Drunk Elephant Umbra Sheer Physical Daily Defense SPF 30 — its sales tripled last year, according to the company — as well as options from the sun specialist Neutrogena.

Some brands, like Chantecaille, are reformulating products to make them mineral-based; a new version of its Ultra Sun Protection Sunscreen Broad Spectrum SPF 45 Primer, made with mineral ingredients, will be introduced next year.


Supergoop Poof 100% Mineral Part Powder
Supergoop Poof 100% Mineral Part Powder

Supergoop uses zinc oxide as the base of a new product, Poof 100% Mineral Part Powder, that aims to protect an area many people forget about: the scalp. Recently the company introduced a collection of creamy SPF 30 eye shadows that derive their sun protection from zinc oxide mixed with octisalate, one of the ingredients the FDA has put into question.

The FDA’s proposal also addresses what formats of SPF are permissible, like powders, which have been on the market but are only now being considered for review as an approved form of SPF.

The FDA, will also suggest raising the maximum SPF value on labels to 60+ from 50 after new data showed the higher SPF to be effective.

“We spend a lot of time in the over-the-counter space trying to make our labels easily understood by consumers,” Michele, of the FDA, said. “And it’s hard for sunscreen.”

Once the proposal is approved, companies looking to sell sunscreens outside of its rules will need to seek new drug applications.

Can we give up chemicals?

It’s hard for many consumers to abandon chemical sunscreens, which are effective and have a lighter, less occlusive feel than a lot of the mineral-based options, which don’t blend the way chemical sunscreen does and so can leave a chalky or ashy finish.

Doctors frequently recommend a compromise. Dr. Macrene Alexiades, a dermatologist in Manhattan and an associate clinical professor at Yale University, suggests that patients use mineral sunscreen on their bodies, but a high-SPF chemical one, despite the concerns, on the face. (Alexiades has a skin care line, 37 Actives, that includes a product with an ingredient on the FDA GRASE list.)

“I’m measuring the risk to you for your quality of life if you have melasma, the risk to you if you have a predisposition to skin cancer, versus the infinitesimally small risk if you apply only to that very small surface area, which is probably 4% of the body,” Alexiades said. “The chances that you’re getting any substantive systemic absorption are very, very low.”

Although the FDA could change its proposal before it is final — and has invited the public to comment on it, along with makers of sunscreens — its articulated concern about specific ingredients seems likely to make an impact.

“Just that statement alone will educate consumers,” Leiba said, adding that she felt the market would, as she put it, “organically shift.”