Health Canada’s monograph classes a sunscreen as a natural health product if it contains only titanium dioxide and zinc oxide as medicinal ingredients. Each is limited to 25 %, and the limit applies to the sum of nano and non-nano forms. Ingredients must be pharmacopoeial grade, and finished-product specifications must follow the NNHPD Quality of Natural Health Products Guide, whose topical limits are 3 ppm arsenic, 3 ppm cadmium, 10 ppm lead, 1 ppm total mercury and 5 ppm antimony. The monograph’s youngest subpopulation is infants from 6 months.
Key numbers
- Table 1 (PDF p. 3): titanium dioxide ≤ 25 %; zinc oxide ≤ 25 %; nano forms included, with nano plus non-nano summed (footnotes 5 and 6).
- Footnote 2 (PDF p. 3): ingredient must be pharmacopoeial grade.
- Subpopulations (PDF p. 8): infants 6 to 12 months, children 1 to 11 years, adolescents and adults; product-facts directions read “Adults, adolescents and children over 6 months of age” (PDF p. 11).
- Specifications (PDF p. 10): nano titanium dioxide and zinc oxide supported when not used in applications leading to lung exposure by inhalation; refers to EU Annex VI for nanomaterial characteristics.
Methods (brief)
Monograph text with revision history from 2006-10-12 to 2026-02-27.
Evidence fitness
Supports the Canadian permitted-ingredient and concentration framework for mineral sunscreens and links them to the topical heavy-metal limits in the NNHPD Quality Guide. The metal limits themselves live in that guide, not in this monograph.
Limitations
Monograph only; products containing Table 2 (drug) ingredients follow the Food and Drug Regulations instead.
Related evidence
- Quality of Natural Health Products Guide
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast)
- Baby Sunscreen, Mineral (ZnO + TiO2)
Update history
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