Is sunscreen safe?
Sunscreen has been in the news a lot lately. This news has some people wondering whether sunscreen is safe, especially considering the U.S. Food and Drug Administration's (FDA) announcement that it will update regulatory requirements for most sunscreen products sold in the United States.
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. Shade is especially important during this time and 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, using a sunscreen that offers broad-spectrum protection, water-resistance, and SPF 30 or higher.
Scientific studies support wearing sunscreen on a regular basis to protect against skin cancer. The FDA continues to tell Americans that they should apply sunscreen. In fact, after the FDA announced that it's asking for more information about sunscreen ingredients, the FDA added the following language to its website:
"Given the recognized public health benefits of sunscreen use, Americans should continue to use sunscreen and other sun protective measures as this important rule-making effort moves forward."1
Sunscreen plays a key role in protecting your skin from the sun. When you use a broad-spectrum sunscreen with SPF 30 or higher, it can:
Reduce your risk of developing skin cancer
Decrease signs of aging on your skin
I recently read an article that suggests the FDA is saying many sunscreen ingredients are unsafe. Is this true?
No, but the regulatory language can be confusing. What the FDA has done is issue a proposed rule, which asks manufacturers to provide more data about the safety of several sunscreen ingredients. These sunscreen ingredients have been used in the United States for years.
Why is the FDA concerned about these sunscreen ingredients?
The FDA is asking for more safety data to find out the following:
To what extent your skin absorbs sunscreen ingredients
Whether absorbing sunscreen has any effects on your skin or body
What does the FDA proposed rule say?
This proposal rule classifies sunscreen ingredients.
The FDA is proposing that two ingredients are “generally recognized as safe and effective” (GRASE). These ingredients are:
The FDA proposes that two other ingredients are not GRASE:
Not to worry. You won’t find either of these ingredients in sunscreen legally sold in the United States.
The FDA is calling for more safety data on the following 12 ingredients before determining whether these ingredients can 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.
Should I stop using sunscreens that contain any of the 12 ingredients that the FDA wants more safety data on?
While the FDA is asking for more data, it does not said 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 safety data. However, the study noted that the data do not conclude that there are any effects on a person’s health and more research would be needed before it that can be determined. Importantly, the study authors stated that individuals should continue to use sunscreen.
What is the difference between the types of sunscreen?
There are two types of sunscreen, and each protects you differently.
Chemical sunscreens work like a sponge, absorbing the sun’s rays.
They contain one or more of the following active ingredients, oxybenzone, avobenzone, octisalate, octocrylene, homosalate, or octinoxate.
These sunscreens tend to be easier to rub into your skin without leaving a white residue.
Physical sunscreens (also known as mineral sunscreens) act like a shield. Sitting on the surface of your skin, they deflect the sun’s rays.
They contain the active ingredients titanium dioxide, zinc oxide, or both.
If you have sensitive skin, opt for this type of sunscreen.
Say Yes to Sun Protection
This infographic gives important information on how to protect against skin cancer, including detailing the difference between physical sunscreen and chemical sunscreen.
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:
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 and publish these in a document called a monograph.
If the FDA considers ingredients in a sunscreen as GRASE, then the product can be manufactured without going through an FDA approval process.
What does it mean that the FDA has issued this 'proposed rule'?
A proposed rule is the first step in the FDA’s regulatory process. When the FDA issues a proposed rule, it asks industry and other interested parties to submit comments, additional data, or both within 90 days. For this current proposed rule on sunscreen, the deadline for submitting data and comments is May 28, 2019.
The FDA must deliver its final monograph by November 26, 2019, as required by Congress.
What happens after the FDA delivers its monograph?
Once the finalized monograph is put into effect, any sunscreen that contains active ingredients that are not in the monograph must go through a New Drug Application (NDA) process. The sunscreen cannot be sold in the United States until it goes through this process and gets FDA approval.
Does the FDA’s proposed rule address any environmental concerns about sunscreen ingredients, namely oxybenzone and octinoxate?
No, it doesn’t specifically ask for this information.
If you have other questions about the safety of sunscreen, ask a board-certified dermatologist. These doctors are familiar with the FDA proposed rule and sunscreen studies in general.
Related AAD resources
Say Yes to Sun Protection (infographic)
1U.S. Food and Drug Administration. “Sunscreen: How to help protect your skin from the sun.” Last updated 2/21/2019. Last accessed 12/2/2019.