On the other hand, the U.S. Food and Drug Administration (FDA) in their Final Administrative Order on Sunscreen Drug Products posted in September 2021 still accepts titanium dioxide up to 25% in the list of Generally Recognized As Safe and Effective (GRASE) in the main document, without further clarification on what kind or size of particles [9]. However, on page 24 (Sunscreen containing nanomaterials) FDA clearly “distinguish nanomaterials from other forms of these ingredients'' (zinc oxide and titanium dioxide) and ask for comments on “any particular nanomaterials that you believe should not be permitted for use in OTC sunscreen products”. To the best of our knowledge, this Agency did not ban the use of nanoparticulate titanium dioxide in any form, even though it is mentioned on page 34 that the anatase form is the more photoactive one, due to the lack of evidence with real sunscreens OTC (over the counter) in vivo. Moreover, other regulations in Latin America (MERCOSUR agreement, 2006) do not state clearly their position on the use of nanoparticulate TiO₂NPs [10].

Micronized titanium dioxide doesn’t penetrate skin so there’s no need to be concerned about it getting into your body. Even when titanium dioxide nanoparticles are used, the molecular size of the substance used to coat the nanoparticles is large enough to prevent them from penetrating beyond the uppermost layers of skin. This means you’re getting the sun protection titanium dioxide provides with no risk of it causing harm to skin or your body. The coating process improves application, enhances sun protection, and prevents the titanium dioxide from interacting with other ingredients in the presence of sunlight, thus enhancing its stability. It not only makes this ingredient much more pleasant to use for sunscreen, but also improves efficacy and eliminates safety concerns. Common examples of ingredients used to coat titanium dioxide are alumina, dimethicone, silica, and trimethoxy capryl silane.