The FDA has approved a new active sunscreen ingredient called bemotrizinol, giving parents expanded options for protecting infants and young children from harmful ultraviolet radiation. This regulatory decision reflects the agency's ongoing effort to ensure sunscreen products meet rigorous safety and effectiveness standards before reaching consumers. Understanding how sunscreen regulations work, and what the FDA recommends for babies at different ages, can help parents make informed choices about sun protection.

Why Does the FDA Regulate Sunscreen Ingredients?

Sunscreens are classified as over-the-counter drugs by the FDA, which means every active ingredient must be tested and approved to confirm it is both safe and effective. The agency has established a list of permitted active ingredients that manufacturers can use, and it regularly reviews new candidates based on scientific evidence. In June 2026, bemotrizinol joined that approved list, joining other common sunscreen actives like zinc oxide, titanium dioxide, avobenzone, and oxybenzone.

This approval process matters because research has shown that at least some sunscreen active ingredients are absorbed through the skin and enter the bloodstream. The FDA takes this seriously and has requested safety data from industry to confirm that exposure to sunscreen ingredients does not pose health risks, especially for vulnerable populations like infants and young children.

What Are the FDA's Recommendations for Babies Under Six Months?

The FDA's guidance on infant sun protection is clear and conservative. Sunscreen is not recommended for babies under six months old. Instead, the agency advises keeping infants out of direct sun entirely, particularly during peak UV hours between 10 a.m. and 2 p.m., when the sun's rays are most intense. If an infant must be in the sun, protective clothing is the preferred option.

This recommendation exists because infants face a greater risk of adverse reactions to sunscreen than older children and adults, including rash and skin irritation. The best protection for babies under six months is simply to avoid sun exposure. Parents who have questions about whether to apply sunscreen to a baby under six months should consult their pediatrician before doing so.

How to Protect Babies and Young Children from Sun Damage

• Age-Appropriate Sunscreen Use: For children over six months old, the FDA recommends using sunscreen as directed on the Drug Facts label. Choose a broad-spectrum product with an SPF of at least 15 to protect against both UVA and UVB radiation.
• Protective Clothing: Long-sleeved shirts, pants, wide-brimmed hats, and sunglasses provide a physical barrier against UV rays. This approach works for all ages and is especially important for infants under six months.
• Timing and Reapplication: Apply sunscreen 15 minutes before sun exposure to allow it to form a protective layer. Reapply at least every two hours, and more frequently if your child is swimming or sweating heavily.
• Adequate Coverage: An average-sized child needs about one ounce of sunscreen, roughly the amount of a shot glass, to cover the entire body from head to toe. Pay special attention to easily missed areas like the ears, nose, back of the neck, tops of feet, and along the hairline.
• Avoid Peak Sun Hours: Limit outdoor time between 10 a.m. and 2 p.m., when ultraviolet radiation is strongest and the risk of sunburn is highest.

What Should Parents Know About Sunscreen Formulations and Water Resistance?

Sunscreens come in multiple formulations, including lotions, creams, sticks, gels, oils, butters, pastes, and sprays. Each type has different application instructions, so reading the label before use is essential. For example, spray sunscreens should never be applied directly to the face due to inhalation risks.

A common misconception is that sunscreen is "waterproof." The FDA clarifies that no sunscreen is truly waterproof; all sunscreens eventually wash off. Products labeled "water resistant" have been tested to confirm they maintain effectiveness for either 40 or 80 minutes during swimming or sweating, but they still require reapplication afterward. Parents should check the label to see which duration applies to their chosen product.

Another important detail: sunscreen containers should be protected from excessive heat and direct sun to maintain effectiveness. The FDA recommends wrapping bottles in towels or keeping them in the shade during extended outdoor time. This is why all sunscreen labels must include the warning to protect the product from excessive heat and direct sun.

Understanding SPF Values and Broad-Spectrum Protection

SPF, or sun protection factor, indicates the level of protection a sunscreen provides against sunburn. However, SPF is often misunderstood. It does not relate directly to time spent in the sun. For example, an SPF 15 sunscreen does not allow someone to stay in the sun 15 times longer without burning; instead, it indicates the ratio of UV exposure needed to cause sunburn with the product versus without it. Solar intensity varies based on time of day, geographic location, and latitude, so the actual protection time depends on many factors.

Broad-spectrum sunscreens protect against both UVA and UVB radiation, which is important because UVA rays contribute to skin aging and skin cancer risk, while UVB rays cause sunburn. The FDA recommends choosing a broad-spectrum sunscreen with an SPF of at least 15. Products that are not broad-spectrum or lack an SPF of 15 must carry a warning label stating they help prevent sunburn only, not skin cancer or early skin aging.

The approval of bemotrizinol as a new active ingredient adds to the toolkit available to manufacturers developing safe and effective sun protection products. As parents navigate the many sunscreen options on the market, understanding FDA regulations, age-appropriate recommendations, and proper application techniques can help ensure their children receive adequate protection from the sun's harmful rays while minimizing unnecessary exposure to ingredients that may not be appropriate for their age group.