Currently, the Canadian Natural Health Products Ingredients Database (NHPID) lists Titanium dioxide (TiO2) as an opacifying agent and color additive for topical use, but is NOT permitted in sunscreens for these uses. However, according to Cosmetics Alliance Canada, the Natural and Non-Prescription Health Products Directorate (NNHPD) has confirmed that Titanium dioxide will be acceptable as a Non-Medicinal Ingredient in sunscreen products as an opacifying agent and colour additive until the restriction has been consulted on.

Next Steps:

· For sunscreen applications for which you have received a rejection because of the TiO2 restriction, the applications may be re-filed

· For sunscreen applications that were filed and are awaiting a response, or for any new applications, you should not receive questions regarding listing TiO2 as an NMI on the application

· For existing products, there is no requirement to adjust formulations

For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA