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Is sunscreen safe?

Is sunscreen safe?

Sunscreen has been in the news a lot lately. This news has some people wondering whether sunscreen is safe to use.

Mother applying sunscreen to girl's face

Dermatologists understand that you may feel concerned. To help you make informed decisions about your health, you'll find answers to common sunscreen questions that patients have been asking their dermatologists.

What is the safest thing I can do to protect my family from the sun?

Dermatologists recommend that you do the following:

  • Seek shade. The sun’s rays are strongest between 10:00 a.m. and 2:00 p.m. Seek shade when your shadow is shorter than you.

  • Dress to protect yourself from the sun by wearing a lightweight and long-sleeved shirt, pants, a wide-brimmed hat, and sunglasses.

  • Apply sunscreen to all skin that clothing won’t cover. To protect your skin, you need a sunscreen that offers broad-spectrum protection, water-resistance, and SPF 30 or higher.

Sunscreen plays a key role in protecting your skin from the sun. When you use a broad-spectrum sunscreen with SPF 30 or higher and water resistance, it can:

  • Reduce your risk of developing skin cancer

  • Prevent sunburn

  • Decrease signs of early aging on your skin like wrinkles, age spots, and sagging skin

  • Stop existing melasma from darkening and new patches from appearing

  • Reduce the risk of dark spots appearing when acne, psoriasis, or another skin condition clears

Scientific studies support the benefits of wearing sunscreen when you will be outside. That’s why the U.S. Food and Drug Administration (FDA) tells Americans that they should wear sunscreen. On the FDA’s website, it encourages people to wear sunscreen and says:

"Given the recognized public health benefits of sunscreen use, Americans should continue to use sunscreen and other sun protective measures."

Why is sunscreen regulated by the FDA?

In the United States, sunscreen is classified as an over-the-counter (OTC) drug. This means it's a drug that you can buy without a prescription.

The FDA classifies anything “intended to diagnose, cure, mitigate, treat, or prevent disease” as a drug. Sunscreen is classified as a drug because it can:

  • Prevent sunburn

  • Reduce skin cancer (if it's broad spectrum)

  • Decrease early skin aging (if it's broad spectrum)

The FDA is required to monitor OTC drugs. Part of this responsibility requires the FDA to determine which ingredients are GRASE, which means generally safe and effective.

If the FDA considers ingredients in a sunscreen as GRASE, then the product can be manufactured without going through an FDA approval process.

I recently read that the FDA is looking at the safety, effectiveness, and quality of sunscreens. Does this mean sunscreen is unsafe?

Reviewing the safety, effectiveness and quality of sunscreens is one of the FDA’s responsibilities. The FDA’s standards for OTC sunscreen products are very high to ensure patient safety. The FDA’s current recommendations are based on current scientific evidence, and the science doesn’t show that any sunscreen ingredients currently available in the U.S. are harmful to human health.

Why is the FDA looking into sunscreen?

The FDA’s review of sunscreens is a good thing! It means that the FDA is taking steps to ensure the continued safety and efficacy of sunscreen and working to clear up confusion around sunscreen labels.

I understand that the FDA has requested more data on 12 sunscreen ingredients. Should I stop using sunscreens that contain these ingredients?

The FDA is calling for more data on the following 12 ingredients before determining whether these ingredients can continue to be classified as GRASE:

  • Ingredients commonly used in the U.S.: Ensulizole, octisalate, homosalate, octocrylene, octinoxate, oxybenzone, avobenzone.

  • Ingredients not frequently used in the U.S.: Cinoxate, dioxybenzone, meradimate, padimate O, sulisobenzone.

While the FDA is asking for more data, it does not say that the ingredients are unsafe. It does not ask the public to stop using sunscreens that contain any of these ingredients.

A recent study by the FDA looked at four sunscreen ingredients and concluded that absorption of these ingredients into the body supported the need for additional research to determine if the absorption has any effects on a person’s health. As the researchers pointed out, just because an ingredient is absorbed into the bloodstream does not mean that it is harmful or unsafe.

Most importantly, the study authors and the FDA concluded that people should continue to use sunscreen to protect themselves from the sun.

If you have other questions about the safety of sunscreen, ask a board-certified dermatologist. These doctors are familiar with the FDA regulations on sunscreen and sunscreen studies in general.

Related AAD resources

U.S. Food and Drug Administration:

  • “Sunscreen: How to help protect your skin from the sun.” Last updated11/8/2021. Last accessed 3/18/2022.

  • “An update on sunscreen requirements: The deemed final order and the proposed order.” Last updated 9/24/2021. Last accessed 3/18/2022.

  • Shedding light on more sunscreen absorption.” Last updated 1/21/2020. Last accessed 3/18/2022.

Last updated: 4/18/22