Update on Titanium Dioxide in Sunscreens

Delsie Braganza

Delsie joined the Focal Point Research team in 2011 and has been an invaluable asset for our clients. With her strong regulatory and quality assurance background, she is able to help clients understand the Canadian and US requirements, set targets to achieve compliance, and attain their goals to get products to market.

Delsie is able to audit facilities, set up and maintain GMP compliant facilities, develop strong quality management systems, and co-ordinate successful Health Canada inspections. In addition to this, Delsie oversees all regulatory compliance reviews and submissions made to Health Canada and the US FDA.

Delsie obtained an Honours Bachelor of Science (Hons. B. Sc.) in Pharmaceutical Chemistry from the University of Toronto, Post-Graduate Certificate in Pharmaceutical Regulatory Affairs and Quality Operations (RAQ) from Seneca College and Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS).

When she’s not learning something new, Delsie loves spending time with family, going on road trips or long walks, and swimming.

Jennifer Porter, BA Psychology, MBA – President & CEO

Having started at Focal Point Research in 2011, Jenn has been fully engaged in the company and since day one, has leveraged her MBA and interest in the regulated products industries to grow her passion for the business and services offered.

Jenn has excelled at building on initial conversations with a variety of companies from all industries seeking regulatory and quality assurance services. She has developed strong relationships with each client, offering each one a unique opportunity to have the Focal Point Research team help them develop successful strategies and bring products to market, while ensuring their compliance needs are being fulfilled.

Jenn has not only been a leader internally, but a key contact for all clients and in 2021, Jenn was the obvious choice to lead Focal Point Research into the future as the successor to company founder, Rob Fichtner.

Jennifer balances her career by honouring her wanderlust, spending her leisure time golfing, and enjoying the outdoors with her loving dog.

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

Delsie Braganza

Jennifer Porter, BA Psychology, MBA – President & CEO

Update on Titanium Dioxide in Sunscreens

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