Sunscreen products intended to protect consumers from the sun are regulated as drugs. Products intended both as makeup and sun protection are both cosmetics and drugs.
Why is sunscreen a cosmetic?
The intended purpose of a sunscreen product is to protect human skin against UV exposure and the intended purpose of a medicinal product is to prevent or to treat a disease. A cosmetic product cannot be a medicinal product at the same time or vice versa.
What category is sunscreen?
Depending on the mode of action, sunscreens can be classified into physical sunscreens (i.e., zinc oxide and titanium dioxide, which stay on the surface of the skin and mainly deflect the UV light) or chemical sunscreens (i.e., UV organic filters, which absorb the UV light).
Is sunscreen a medical device?
On June 14, 2011, the United States Food and Drug Administration (FDA) published a final rule for sunscreen Over the Counter (OTC) drug products that mandated revised SPF, Water Resistance and Broad Spectrum testing procedures. … In the United States, however, sunscreens are regulated as drugs.
Is sunscreen considered an OTC?
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.
Is sunscreen considered a pharmaceutical?
Any sunscreen sold in the United States is regulated as a drug because it makes a drug claim – to help prevent sunburn or to decrease the risks of skin cancer and early skin aging caused by the sun.
Does SPF 15 Protect your face?
Regular daily use of SPF 15 sunscreen can reduce your risk of developing squamous cell carcinoma (SCC) by about 40 percent, and lower your melanoma risk by 50 percent. Help prevent premature skin aging caused by the sun, including wrinkles, sagging and age spots.