Anthelios SX, a L’Oreal sunscreen product, has been approved by the FDA to be sold over-the-counter (OTC). Anthelios SX, which has a sun-protection-factor (SPF) of 15, protects against sunburn, ultraviolet B (UVB) and ultraviolet A (UVA) rays.
Dr. Steven Galson, Director of the Center for Drug Evaluation and Research at the FDA said that sunscreens are an important part of total sun protection strategy. He said people need to protect themselves from damaging sun rays. Although Anthelios SX offers protection from UVA and UVB rays, Galson said people should also try to limit the amount of time they are exposed to the sun.
Anthelios SX contains three active ingredients:
Ecamsule
This is a new molecular entity, marketed in Europe and Canada as Mxoryl SX since 1993. It has not been marketed in the USA.
Avobenzone
Recognized as safe and effective under the OTC monograph for sunscreens.
Octocylene
Recognized as safe and effective under the OTC monograph for sunscreens.
The FDA looked at 28 studies, including 2,500 participants, aged 6 months to 65 years. Trials reported non-serious and infrequent side-effects, which included acne, dermatitis, dry skin, abnormal redness, itching, eczema and skin discomfort.
LaRoche-Posay will distribute Anthelios SX in the USA.
(OTC = Over-the-counter = A product you can buy without needing a doctor’s prescription)
Written by: Christian Nordqvist
Editor: Medical News Today