Parsol Shield: FDA Approves New Sunscreen Active Ingredient for Broad UV Protection

Bemotrizinol is a sunscreen active ingredient that helps protect your skin from ultraviolet A (UVA) and ultraviolet B (UVB) rays. Parsol Shield is expected to be the first sunscreen available with this ingredient. The FDA has determined that bemotrizinol is safe and effective for use in OTC sunscreens for adults and children 6 months and older.

Bemotrizinol is the first new sunscreen ingredient approved for use in over-the-counter products in the United States since the late 1990s.

According to the American Academy of Dermatology, sunscreen plays an important role in public health in the U.S., where skin cancer is the most common cancer and is expected to affect about 1 in 5 Americans during their lifetime. Regular use of broad-spectrum and water-resistant sunscreen helps protect the skin from harmful UV rays, reducing the risk for sunburn and skin cancer, including melanoma, the deadliest form of skin cancer.

Bemotrizinol has been used as a sunscreen component across Europe and other parts of the world for several years.

Why Was It Approved?

The FDA has a set of rules that sunscreen makers must follow to sell a product without going through a lengthy individual drug approval process. These rules cover which ingredients are allowed, how they can be used, and at what amounts. When a company wants to add a new ingredient, they can submit a request to the FDA. The agency reviews the science, opens the process up for public input, and then makes a final decision. That is how bemotrizinol, at amounts up to 6%, was approved for use in U.S. sunscreens.

Studies involving nearly 500 people from diverse backgrounds showed that bemotrizinol was effective, well tolerated, and absorbed into the body at very low levels. The ingredient can help protect against sunburn, skin cancer, premature aging, and other long-term skin damage from sun exposure. It also allows manufacturers to develop lightweight, long-lasting sunscreens that are comfortable to wear.

What Do I Need to Know?

Bemotrizinol has been used safely in sunscreens in Europe for many years. Now that it has FDA approval, Americans can expect to see more sunscreen options on store shelves that include this ingredient.

Any sunscreen containing bemotrizinol must follow FDA guidelines, including using no more than 6% of the ingredient in the formula. When shopping, look for sunscreens that protect against both UVA and UVB rays (often labeled “broad spectrum”) and check the active ingredients list to see what your sunscreen contains.

Talk with your health care provider if you have questions about which sunscreen is right for you, or about using sunscreen on a baby younger than 6 months.

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