A Sunscreen Message for Consumers (2:35)
FDA regulates sunscreens to ensure they meet safety and effectiveness standards. To improve the quality, safety, and effectiveness of sunscreens, FDA posted a proposed order on September 24, 2021 that describes updated proposed requirements for sunscreens. Given the recognized public health benefits of sunscreen use, Americans should continue to use sunscreen with other sun protective measures as this important effort moves forward.
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As an FDA-regulated product, sunscreens must pass certain tests before they are sold. But how you use this product, and what other protective measures you take, make a difference in how well you are able to protect yourself and your family from sunburn, skin cancer, early skin aging and other risks of overexposure to the sun. Some key sun safety tips include:
- Limit time in the sun, especially between the hours of 10 a.m. and 2 p.m., when the sun’s rays are most intense.
- Wear clothing to cover skin exposed to the sun, such as long-sleeved shirts, pants, sunglasses, and broad-brimmed hats.
- Use broad spectrum sunscreens with SPF values of 15 or higher regularly and as directed.
- Reapply sunscreen at least every two hours, and more often if you're sweating or jumping in and out of the water.
Learn more about:
- Apply 15 minutes before you go outside. This allows the sunscreen (of SPF 15 or higher) to have enough time to provide the maximum benefit.
- Use enough to cover your entire face and body (avoiding the eyes and mouth). An average-sized adult or child needs at least one ounce of sunscreen (about the amount it takes to fill a shot glass) to evenly cover the body from head to toe.
Frequently forgotten spots:
Back of neck
Tops of feet
Along the hairline
Areas of the head exposed by balding or thinning hair
- Know your skin. Fair-skinned people are likely to absorb more solar energy than dark-skinned people under the same conditions.
- Reapply at least every two hours, and more often if you’re swimming or sweating.
There’s no such thing as waterproof sunscreen
People should also be aware that no sunscreens are "waterproof.” All sunscreens eventually wash off. Sunscreens labeled "water resistant" are required to be tested according to the required SPF test procedure. The labels are required to state whether the sunscreen remains effective for 40 minutes or 80 minutes when swimming or sweating, and all sunscreens must provide directions on when to reapply.
Watch: Videos about sunscreen
Storing your sunscreen
To keep your sunscreen in good condition, the FDA recommends that sunscreen containers should not be exposed to direct sun. Protect the sunscreen by wrapping the containers in towels or keeping them in the shade. Sunscreen containers can also be kept in coolers while outside in the heat for long periods of time. This is why all sunscreen labels must say: “Protect the product in this container from excessive heat and direct sun.”
Sunscreens are not recommended for infants. The FDA recommends that infants be kept out of the sun during the hours of 10 a.m. and 2 p.m., and to use protective clothing if they have to be in the sun. Infants are at greater risk than adults of sunscreen side effects, such as a rash. The best protection for infants is to keep them out of the sun entirely. Ask a doctor before applying sunscreen to children under six months of age.
For children over the age of six months, the FDA recommends using sunscreen as directed on the Drug Facts label.
Sunscreen comes in many forms, including:
The directions for using sunscreen products can vary according to their forms. For example, spray sunscreens should never be applied directly to your face. This is just one reason why you should always read the label before using a sunscreen product.
Note: FDA has not authorized the marketing of nonprescription sunscreen products in the form of wipes, towelettes, powders, body washes, or shampoos.
Not all sunscreens are broad spectrum, so it is important to look for it on the label. Broad spectrum sunscreen provides protection from the sun’s ultraviolet (UV) radiation. There are two types of UV radiation that you need to protect yourself from – UVA and UVB. Broad spectrum provides protection against both by providing a chemical barrier that absorbs or reflects UV radiation before it can damage the skin.
Sunscreens that are not broad spectrum or that lack an SPF of at least 15 must carry the warning:
"Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”
Sunscreens are made in a wide range of SPFs.
The SPF value indicates the level of sunburn protection provided by the sunscreen product. All sunscreens are tested to measure the amount of UV radiation exposure it takes to cause sunburn when using a sunscreen compared to how much UV exposure it takes to cause a sunburn when not using a sunscreen. The product is then labeled with the appropriate SPF value. Higher SPF values (up to 50) provide greater sunburn protection. Because SPF values are determined from a test that measures protection against sunburn caused by UVB radiation, SPF values only indicate a sunscreen's UVB protection.
As of June 2011, sunscreens that pass the broad spectrum test can demonstrate that they also provide UVA protection. Therefore, under the label requirements, for sunscreens labeled "Broad Spectrum SPF [value]", they will indicate protection from both UVA and UVB radiation.
To get the most protection out of sunscreen, choose one with an SPF of at least 15.
If your skin is fair, you may want a higher SPF of 30 to 50.
There is a popular misconception that SPF relates to time of solar exposure. For example, many people believe that, if they normally get sunburned in one hour, then an SPF 15 sunscreen allows them to stay in the sun for 15 hours (e.g., 15 times longer) without getting sunburn. This is not true because SPF is not directly related to time of solar exposure but to amount of solar exposure.
The sun is stronger in the middle of the day compared to early morning and early evening hours. That means your risk of sunburn is higher at mid-day. Solar intensity is also related to geographic location, with greater solar intensity occurring at lower latitudes.
Every drug has active ingredients and inactive ingredients. In the case of sunscreen, active ingredients are the ones that are protecting your skin from the sun’s harmful UV rays. Inactive ingredients are all other ingredients that are not active ingredients, such as water or oil that may be used in formulating sunscreens. Below is a list of acceptable active ingredients in products that are labeled as sunscreen:
Although the protective action of sunscreen products takes place on the surface of the skin, there is evidence that at least some sunscreen active ingredients may be absorbed through the skin and enter the body. This makes it important to perform studies to determine whether, and to what extent, use of sunscreen products as directed may result in unintended, chronic, systemic exposure to sunscreen active ingredients.
FDA regulations require all sunscreens and other nonprescription drugs to have an expiration date unless stability testing conducted by the manufacturer has shown that the product will remain stable for at least three years. That means, a sunscreen product that doesn’t have an expiration date should be considered expired three years after purchase.
To make sure that your sunscreen is providing the sun protection promised in its labeling, the FDA recommends that you do not use sunscreen products that have passed their expiration date (if there is one), or that have no expiration date and were not purchased within the last three years. Expired sunscreens should be discarded because there is no assurance that they remain safe and fully effective.
In Europe and in some other countries, sunscreens are regulated as cosmetics, not as drugs, and are subject to different marketing requirements. Any sunscreen sold in the United States is regulated as a drug because it makes a drug claim - to help prevent sunburn or to decrease the risks of skin cancer and early skin aging caused by the sun.
If you purchase a sunscreen outside the United States, it is important to read the label to understand the instructions for use and any potential differences between the product and U.S. products.
Additional Consumer Information
- Don't Fry Day (the Friday before Memorial Day)
Protect your skin while enjoying the outdoors
- CDC Sun Safety
- EPA SunWise: Sun Safety
- Skin Cancer Screening
This site is intended to provide a source of general information on skin tanning, ultraviolet (UV) exposure, UV emitting products, and skin protection.
- Sunscreen Innovation Act
- Rulemaking History for OTC Sunscreen Drug Products
- Press Release: FDA Takes Steps Aimed at Improving Quality, Safety and Efficacy of Sunscreens
- CDER Conversation: An update on sunscreen requirements: The deemed final order and the proposed order
- Deemed Final Order: Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use
- Notice of Availability for Proposed Order: Amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug Products for OTC Human Use
- Questions and Answers: FDA posts deemed final order and proposed order for over-the-counter sunscreen
- Stakeholder Call on 9/27/2021: FDA Takes Steps to Improve the Quality, Safety and Efficacy of Sunscreen
- Industry Fact Sheet (PDF - 97 KB)