New OTC Sunscreen Product Approved by FDA

New OTC Sunscreen Product Approved by FDA

Almost everyone has been sunburned or will become sunburned at some time. Anyone who visits a beach, goes fishing, works in the yard, or simply is out in the sun can get sunburn. Improper tanning bed use is also a source of sunburn. Although seldom fatal, sunburn can be disabling and cause quite a bit of discomfort.Sunburn results from too much sun or sun-equivalent exposure. Sufficient exposure can become remarkably painful.


Initially, your skin turns red about 2-6 hours after exposure and feels irritated. The peak effects are noted at 12-24 hours. More severe cases, such as those experienced by rafters (Cuban and other island peoples fleeing their countries on homemade rafts) are complicated by severe skin burning and blistering, massive fluid loss (dehydration), electrolyte imbalance, and infection. Other common symptoms include:

Sunscreen (also known as sunblock, suntan lotion) is a lotion, spray or other topical product that helps protect the skin from the sun's ultraviolet radiation, and which reduces sunburn and other skin damage, ultimately leading to a lower risk of skin cancer.

The best sunscreens protect against both UVB (ultraviolet radiation with wavelength between 290 and 320 nanometres), which can cause sunburn, and UVA (between 320 and 400 nanometres), which damages the skin with more long-term effects, such as premature skin aging. Most sunscreens work by containing either an organic chemical compound that absorbs ultraviolet light (such as oxybenzone) or an opaque material that reflects light (such as titanium dioxide, zinc oxide), or a combination of both. Typically, absorptive materials are referred to as chemical blocks, whereas opaque materials are mineral or physical blocks.

The Food and Drug Administration (FDA) recently approved Anthelios SX, a sunscreen from L'Oreal to be sold over-the-counter (OTC) for the prevention of sunburn and for protection against ultraviolet B (UVB) and ultraviolet A (UVA) rays. It has a sun protection factor (SPF) of 15.

"Sunscreens are an important part of total sun protection strategy as consumers arm themselves against the harmful sun rays," said Steven Galson, M.D., Director of the Center for Drug Evaluation and Research. "While this product provides protection from harmful UVA and UVB rays, FDA continues to recommend that in addition to using a sunscreen, consumers protect themselves from sun exposure by limiting time in the sun and wearing protective clothing."

Anthelios SX is a sunscreen product that contains a combination of three active ingredients. One of the ingredients is a new molecular entity (NME), ecamsule. Ecamsule has not been marketed in the United States, but has been marketed in Europe and Canada as Mexoryl SX since 1993. The other two active ingredients, avobenzone and octocrylene, are generally recognized as safe and effective under the current OTC monograph for sunscreens.

The safety and efficacy data for Anthelios SX included information from 28 studies in over 2500 patients, ranging in age from 6 months to over 65 years old. In addition, the contribution of each of the active ingredients to sun protection was studied.

Side effects reported during clinical studies were infrequent and non-serious. The most common side effects in patients were acne,
dermatitis, dry skin, eczema, abnormal redness, itching, skin discomfort and sunburn.

The product will be distributed by LaRoche-Posay.

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