Are sunscreens approved by the FDA?

Author: Christiana Gislason  |  Last update: Tuesday, December 30, 2025

Just as it does with other nonprescription drug products, FDA regulates sunscreens to ensure they meet safety and effectiveness standards.

Why won't the FDA approve new sunscreens?

The fact that sunscreen is classified as a drug in the US means it has to go through the same testing and safety protocols that the FDA requires in order to gain approval. Usually these tests need to be done on a wide pool of animals and then humans so it is very very costly.

Can you sell sunscreen without FDA approval?

In the US, it would be illegal to sell a product that claims to protect from the sun if it has not been approved by the FDA.

Which is the safest sunscreen to use?

Mineral sunscreens (i.e., physical sunscreens) are safer than chemical sunscreens for your health and the planet. They contain the minerals titanium dioxide and/or zinc oxide, which physically sit on the skin's surface (rather than penetrating the skin) and reflect or refract UV radiation from the skin.

How much does it cost to get sunscreen FDA approved?

The FDA estimates a one-time cost of $2,200 per sunscreen product to test for UVA protection. In addition to testing, manufacturers must also comply with labeling requirements, as seen in FIGURE 1. The estimated costs for relabeling sunscreen products are $7,600 per product.

FDA: Sunscreen rules

Why is sunscreen so expensive in the US?

The use of quality ingredients and formulations ensures our skin is effectively protected from harmful UV rays while catering to various skin types and concerns. The investment in research and development, as well as adhering to regulatory guidelines, contributes significantly to the final price.

How do I know if my sunscreen is FDA approved?

Verify the product.

The FDA regulates sunscreen products, it is highly advised to purchase only products that have been notified with the FDA. To check if a product is notified with the FDA, use the FDA Verification Portal feature accessible at https://verification.fda.gov.ph.

What sunscreen not to get?

Due to the health concerns associated with oxybenzone, EWG recommends consumers avoid sunscreens with oxybenzone. Octinoxate is a non-mineral UV filter.

What is the #1 best sunscreen?

The Best Sunscreen

Blue Lizard has reformulated its Sensitive Mineral Sunscreen SPF 50+, our top pick. It now contains an aloe extract and the SPF booster butyloctyl salicylate, among other inactive ingredients. The active ingredients, zinc oxide (10%) and titanium dioxide (8%), remain the same.

When was the last time the FDA approved sunscreen?

The last time the Food and Drug Administration approved any new active ingredients for sunscreen that helped to block our skin from ultraviolet rays was 1999.

Does deodorant need FDA approval?

Some examples are skin moisturizers, perfumes, lipsticks, fingernail polishes, makeup, shampoos, permanent waves, hair colors, toothpastes, and deodorants. These products and their ingredients are not subject to FDA premarket approval, except color additives (other than coal tar hair dyes).

Which sunscreens failed the test?

Three lotions, from Calypso Sun, Bondi Sands and Asda did not pass all the tests - but others, including some cheaper options from supermarkets Aldi and Lidl, did.

Why is the US behind on sunscreen?

So why are we behind Europe and Asia on something as essential as sunscreens? The answer lies in the 1938 Federal Food, Drug, and Cosmetic Act, which requires sunscreens to be tested on animals and classified as drugs rather than as cosmetics.

Does sunscreen expire?

The U.S. Food and Drug Administration requires that sunscreen remain at its original strength for at least three years. That means you can use leftover sunscreen from one year to the next. Some sunscreens include an expiration date — the date when they're no longer effective.

Is blue lizard a good sunscreen?

Blue Lizard is regarded as one of the best skincare brands when it comes to sun care — at one point, its products were only really available at dermatologists' offices.

Does SPF 50 mean 50 minutes?

Put another way, if your unprotected skin would take ten minutes to show signs of burning, then properly applying SPF 30 sunscreen would slow the rate of burning to the point where it would take 30 times longer, or 300 minutes in total. SPF 15 would take 150 minutes, while SPF 50, 500 minutes.

Why is SPF not recommended?

SPF values do not reflect a product's ability to protect from UVA rays, which penetrate the skin more deeply than UVB rays, and are associated with skin aging and cancer, such as melanoma. SPF values are also unreliable because the test method that companies must use to determine a product's value is imprecise.

Why you shouldn't wear sunscreen every day?

Why You Shouldn't Wear Sunscreen Every Day. If you were to use sunscreen every day, your body would continuously absorb any chemicals it contains, potentially much faster than your body can filter and excrete them.

Which sunscreen ingredient was banned?

Oxybenzone (BP-3) and octinoxate (OMC), two common sunscreen ingredients, were recently banned in Key West and Hawaii due to their toxic effects on marine ecosystems.

How to naturally protect skin from sun?

Simply staying in the shade, especially during midday hours, is one of the best ways to limit your UV exposure from sunlight. Protect your skin with clothing that covers your arms and legs. Wear a wide-brimmed hat to protect your head, face, and neck.

Is o two o FDA approved?

The Food and Drug Administration (FDA) warns the public from purchasing and using the unauthorized cosmetic product, O. TWO. O MATTE LIP TINT KISS PROOF MASKPROOF 24H LONG LASTING LIQUID (VLG 1, VLG 2, VLG 3, VLG 4, VLG 5, VLG 6, VLG 7, VLG 8, VLG 9, VLG 10, VLG 11, VLG 12).

What time of day can you stop wearing sunscreen?

The time when UV exposure is likely to be greatest is between 10 a.m. and 4 p.m. during daylight savings time and during the late spring and early summer in North America. Nonetheless, protection from UV rays is important all year round. UV rays can be as strong on cloudy, hazy days as well as on bright, sunny ones.

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