Sunscreen: How to Help Protect Your Skin from the Sun
Get consumer information about sunscreen and sun protection
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Just as it does with other nonprescription drug products, FDA regulates sunscreens to ensure they meet safety and effectiveness standards. To improve the quality, safety, and effectiveness of sunscreens, FDA proposed updated requirements for sunscreens in September 2021 as directed by the Coronavirus Aid, Relief, and Economic Security (CARES Act). These same proposed requirements were originally described in a proposed rule issued by FDA in 2019. The 2021 proposed order was used to transition FDA’s sunscreen proposals to the new administrative order process established by the CARES Act.
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.
Sun Safety Tips
How you use sunscreens, 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 swimming.
Questions About Sunscreen
General directions:
- Apply 15 minutes before sun exposure. This allows the sunscreen 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.
- Know your skin. Fair-skinned people are likely to absorb more solar energy than dark-skinned people under the same conditions and may be more likely to burn.
- Reapply at least every two hours, and more often if you’re swimming or sweating.
Frequently forgotten spots:
- Ears
- Nose
- Lips (use SPF lip balm)
- Back of neck
- Hands
- Tops of feet
- Along the hairline
- Exposed scalp (from balding or thinning hair)
To keep your sunscreen in good condition and maintain its effectiveness, FDA recommends you not expose sunscreen containers to direct sun. Protect the sunscreen by wrapping the containers in towels or keeping them in the shade while outside in the heat for long periods of time. This is why sunscreen labels must say: “Protect the product in this container from excessive heat and direct sun.”
No. 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" must be tested and found to be water resistant according to the required test procedures. Products labeled as water resistant are also required to state on their labels whether the sunscreen remains effective for 40 minutes or 80 minutes when swimming or sweating. All sunscreens, whether labeled as water resistant or not, must provide directions on when to reapply to ensure protection under usual conditions of use.
Sunscreen is not recommended for infants under six months old. 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, FDA recommends using sunscreen as directed on the Drug Facts label.
Sunscreen comes in many forms, including:
- Lotions
- Creams
- Sticks
- Gels
- Oils
- Butters
- Pastes
- Sprays
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.
Sun protection factor (SPF)
The SPF value indicates the level of sunburn protection provided by the sunscreen product. All sunscreens must be tested to measure the amount of ultraviolet (UV) radiation exposure it takes to cause sunburn when using the sunscreen compared to how much UV exposure it takes to cause a sunburn when not using the sunscreen. UV radiation consists of both UVA and UVB radiation. The product is then labeled with the appropriate SPF value.
Sunscreens are made in a wide range of SPFs. Higher SPF values (up to 50) provide greater sunburn protection. Because SPF values are determined from a test that measures protection against sunburn, SPF values primarily indicate a sunscreen's UVB protection. To get the most protection out of sunscreen, choose a broad-spectrum sunscreen with an SPF of at least 15.
Some people incorrectly believe that SPF relates to time of solar exposure. For example, some 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 amount of solar exposure we experience depends on many factors. For example, 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 impacted by your geographic location, with greater solar intensity occurring at lower latitudes. Because of this, someone who is closer to the equator may experience greater solar exposure than someone who is farther from the equator but spends the same amount of time in the sun.
Broad spectrum
Broad spectrum sunscreens help protect against both forms of UV radiation - UVA and UVB. However, not all sunscreens are broad spectrum, so it is important to look for this description on the label. A sunscreen product’s SPF value is primarily an indicator of the level of protection that product provides against UVB radiation, but broad-spectrum sunscreens also protect against UVA radiation. It is important to always use other sun protection measures, along with your broad spectrum sunscreen, when spending time in the sun. Sunscreen 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 following warning on their Drug Facts label:
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.
Every FDA-regulated drug product 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 commonly used active ingredients in products that are labeled as sunscreen:
- Aminobenzoic acid
- Avobenzone
- Cinoxate
- Dioxybenzone
- Homosalate
- Meradimate
- Octocrylene
- Octinoxate
- Octisalate
- Oxybenzone
- Padimate O
- Ensulizole
- Sulisobenzone
- Titanium dioxide
- Zinc oxide
Although the protective action of sunscreen products takes place on the surface of the skin, there is new evidence that at least some sunscreen active ingredients are absorbed through the skin and enter the body. This makes it important for FDA to determine whether, and to what extent, exposure to certain sunscreen ingredients may be associated with any safety risks. FDA has requested data from industry to confirm the safety of sunscreen active ingredients.
FDA regulations require all nonprescription drugs to have an expiration date unless the manufacturer’s stability testing 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, FDA recommends that you:
- Do not use sunscreen products that have passed their expiration date (if there is one).
- Do not use sunscreen products that have no expiration date and were not purchased within the last three years.
- Discard expired sunscreens because they may not be safe and effective anymore. If you do not know how old your sunscreen is, discard it.
While some countries regulate sunscreens differently (for example, as cosmetics), in the United States, sunscreens are regulated as drugs, which means they must satisfy the safety and efficacy standards for nonprescription drug products in the United States.
Because sunscreens, if used as directed with other sun protection measures, help to prevent sunburn and/or to reduce the risks of skin cancer and early skin aging caused by the sun, it is important that they be both effective and safe for their intended uses.
If you purchase a sunscreen outside of the U.S., it is important to read the label to understand any potential differences between the product and U.S. products.
Spray sunscreens can be flammable
There have been past incidents in which people applying and wearing sunscreen spray near open flames caught fire and, as a result, suffered significant burns that required medical treatment. Although the specific products reported to have been used in these incidents were voluntarily recalled from the market and are no longer on store shelves, there are many other sunscreen spray products which still do contain flammable ingredients, like alcohol.
Flammable products are required to have a label warning indicating that they are flammable and should not be used near an open flame.
To stay safe while using sunscreen sprays, do the following:
- When you choose a sunscreen, think about where you'll be using it. If you'll be anywhere near a flame source, avoid any product with a flammability warning, and choose another non-flammable sunscreen product instead. This recommendation is particularly important when it comes to choosing a product for children, since they are frequently active and may be near flame sources.
- While applying and wearing sunscreen products labeled as flammable, do not smoke, and avoid open flames from lighting cigarettes, lit cigarettes, grilling, candles, or sparking materials.
Because burns have the potential to be more severe in children than adults, keeping children safe near flammable materials is very important. Parents and caregivers should read the product label to choose the right sunscreen for their children.
Recalled sunscreens
You may have heard that certain spray sunscreens were recalled because of benzene contamination. FDA recommends that consumers not use recalled sunscreens. Find out if your sunscreen was recalled.
FDA continues to monitor the quality of drugs and, when appropriate, encourages retailers to remove products from store shelves and online marketplaces when issues arise. Consumers should continue to use sunscreen, along with other sun protection measures, to reduce risks from sun exposure.