There are differing regulatory guidelines for sunscreens around the world and in some countries, sunscreen products are regulated as drugs. The ability to use inorganics as a UV filter therefore varies. For example zinc oxide and titanium dioxide are included in the Final Sunscreen Monograph of the FDA where they are permitted up to a level of 25%. In Japan, zinc oxide and titanium dioxide are permitted for use with no limit on concentration; however they are not included on the positive list of UV filters because they are not considered to be UV absorbers. In Australia, titanium dioxide and zinc oxide are permitted and there is no limit on concentration of zinc oxide, although there is a limit of 25% for titanium dioxide. In Europe, titanium dioxide is included on the Annex VII listing of permitted UV filters. Zinc oxide is not currently listed on Annex VII, although a dossier submission has been made with a view to eventually listing zinc oxide as a UV filter. Zinc oxide is of course already approved, and widely used, as a cosmetic ingredient.
Yes. The titanium dioxide and zinc oxide used in our dispersions are in compliance with USP specifications.
The majority of Croda dispersions comply with regulatory requirements in Japan. Exceptions are Tioveil™ AQ-G, and Solaveil™ CT-10W, which both contain a preservative that is not approved in Japan for leave-on products.
There is currently significant attention to nanomaterials and nanotechnology in general. Much of this is focussed on identifying commercial opportunities for these materials but equally asking questions about their impact on man and the environment. In relation to safety of nanoscale inorganics in cosmetic products, evidence shows that there is no uptake of these materials through the skin, and they are completely safe for topical use.
Detailed further information on this subject is available. Please contact your Croda sales representative if you require further information
Extensive studies have shown that neither titanium dioxide nor zinc oxide penetrate the skin. They stay where they are designed to be, in a film covering the surface of the skin.
No. Aluminium compounds used in coating are precipitated onto the surface of the fine particle titanium dioxide as an oxide or hydroxide and often in combination with stearic acid. These coatings are insoluble and irreversibly stuck to the titania particles. Since the titanium dioxide does not penetrate the skin, the coating compounds also are not taken up in the body, and therefore can have no adverse effects on health. In addition the properties of these coating compounds bear no relation to the properties of aluminium metal. Another example of this is sodium; sodium metal is a highly reactive flammable metal, yet sodium chloride is common salt.
No. Zinc oxide is still an approved cosmetic ingredient and there are no problems with using it. Zinc oxide is classified as ‘dangerous to the environment’ due to algal toxicity and requires appropriate packaging, labelling and transportation in Europe. Cosmetic formulations are not covered by this legislation, so no special labeling or packaging is required for finished formulations which contain zinc oxide.