Sunscreens are registered as API (Active Pharmaceutical Ingredient) or OTC-drug with the FDA. This means that, if you want to sell products containing a sunscreen, your facility must be registered with the FDA and operate under cGMP guidelines. Further information about the FDA regulation of sunscreens can be found in our resource section. If used as colorant, Titanium dioxide is a FDA-approved color additive but is exempt from batch certification. It is safe for use in coloring cosmetics generally, including cosmetics applied to the area of the eye, in amounts consistent with good manufacturing practice.