Sunscreen contains chemical and/or physical active ingredients. Physical ingredients like zinc oxide or titanium oxide reflect or scatter ultraviolet (UV) radiation. Chemical ingredients like avobenzone or oxybenzone absorb UV radiation, dissipating it as heat. Some sunscreens protect us from the two types of damaging UV radiation: UVA and UVB.
These sunscreens are labeled as broad-spectrum sunscreens. The broad-spectrum test measures a product’s ultraviolet A (UVA) protection relative to its ultraviolet B (UVB) protection. Sunscreens that pass this test may be labeled as “Broad-Spectrum SPF (value)” on the front of their label. For broad-spectrum sunscreens, SPF values also indicate the amount or magnitude of overall protection. Broad- Spectrum SPF products with SPF valued higher than 15 provide greater protection and may claim additional uses. Only broad-spectrum sunscreens with an SPF value of 15 or higher can claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Non-Broad-spectrum sunscreens and broad-spectrum sunscreens with an SPF value between 2 and 14 can only claim to help prevent sunburn. Source: U.S. Food and Drug Administration
According to the FDA, an active ingredient is any component of a drug product intended to provide therapeutic and pharmacological activity in direct effect to a diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans. Active ingredients include those components of the product that may undergo chemical change during the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. An inactive ingredient is any component of a drug product other than the active ingredients.
The FDA classifies sunscreens as over-the-counter (OTC) drugs. These sunscreens are formulated with ingredients that are intended to directly affect the prevention of sunburn and skin cancer. Skin care products are under the cosmetic category; therefore they only have inactive ingredients in their formulas.
The broad-spectrum test measures a product’s ultraviolet A (UVA) protection relative to its ultraviolet B (UVB) protection. Sunscreens that pass this test may be labeled as “Broad-Spectrum SPF (value)” on the front of their label. For broad-spectrum sunscreens, SPF values also indicate the amount or magnitude of overall protection. Broad-Spectrum SPF products with SPF valued higher than 15 provide greater protection and may claim additional uses. Only broad-spectrum sunscreens with an SPF value of 15 or higher can claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Non-broad-spectrum sunscreens and broad-spectrum sunscreens with an SPF value between 2 and 14 can only claim to help prevent sunburn.
Zinc oxide is a natural mineral that is safe even on the most sensitive skin, including post-procedure skin and even that of children 6 months or older. Zinc oxide blocks UVB (burning) and UVA (aging) rays that have been linked to photoaging and skin cancer.
SPF or sunburn protection factor indicates the UVB/sunburn protection provided by sunscreen. The SPF value indicates the level of sunburn protection provided by the sunscreen product. All sunscreens must be tested according to an SPF test procedure. The test measures the amount of ultraviolet (UV) radiation exposure it takes to cause sunburn when a person is using a sunscreen in comparison to how much UV exposure it takes to cause sunburn when they do not use a sunscreen. The product is then labeled with the appropriate SPF value indicating the amount of sunburn protection provided by the product. Higher SPF values provide greater sunburn protection. Because SPF values are determined from a test that measures protection against sunburn caused by ultraviolet B (UVB) radiation, SPF values only indicate a sunscreen’s UVB protection. However, sunscreens that pass the new broad-spectrum test will have demonstrated that they also provide ultraviolet A (UVA) protection that is proportional to their UVB protection.
Spending time in the sun increases a person’s risk of skin cancer and early skin aging. To reduce these risks, consumers should regularly use a broad-spectrum sunscreen with an SPF value of 15 or higher in combination with protective measures such as:
Limiting time in the sun, especially between the hours of 10 AM and 2 PM when the sun’s rays are the strongest.
Wearing clothing to cover skin exposed to the sun (long-sleeved shirts, pants, sunglasses, broad-brimmed hats) when possible.
Using a water resistant sunscreen if swimming or sweating.
Reapplying sunscreen, even if it is labeled as water-resistant, at least every 2 hours. (Water-resistant sunscreens should be reapplied more often after swimming or sweating, according to the directions on the label.)
Consumers should also be aware that no sunscreens are “waterproof” because all sunscreens eventually wash off. Sunscreens can only be labeled as “water-resistant” if they are tested according to the required SPF test procedure. Sunscreens labeled “water-resistant” successfully will also be required to state whether the sunscreen remains effective for 40 minutes or 80 minutes when swimming or sweating, and all sunscreens will be required to provide directions on when to reapply.
Since the FDA’s Final Rule went into effect, manufacturers cannot label sunscreens as “waterproof” or “sweatproof”, or identify their products as “sunblocks,” because these claims overstate their effectiveness.
The ingredients in FDA-approved sunscreens marketed today have been used for many years, and the FDA has no reason to believe these products are not safe and effective when used as directed. Therefore, the FDA is not advising consumers to throw away their current sunscreen products, if they have not reached their stated expiration date.
High temperature may cause the ingredients to separate or appear “unblended”. However, the sun protection properties are not affected by temperatures up to 122 degrees F (50 degrees C), the maximum at which the product is tested. Exposure to higher temperatures is a misuse of the product.
Our experience is rooted in formulating products that address critical skin care problems. It is our medical heritage that differentiates EltaMD skin care products. For more than two decades, our company has formulated moisturization products for wound and skin treatment in hospitals, burn centers and acute care facilities.
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On June 14, 2011 the U.S. Food and Drug Administration (FDA) announced new requirements for sunscreens currently sold over-the-counter (OTC) (i.e. non-prescription). These requirements support the Agency’s ongoing efforts to ensure that sunscreens meet modern-day standards for safety and effectiveness. Download this article for a brief overview of the recent regulatory actions.