This monograph describes the requirements necessary to receive market authorization [i.e. a Drug Identification Number (DIN) or a Natural Product Number (NPN)], for primary sunscreen products. The monograph identifies the permitted medicinal and non-medicinal ingredients, concentrations, indications, directions and conditions of use for these products to be market authorized without the submission to Health Canada of additional evidence. It also may contain the test methods recommended to be used to comply with the requirements of this monograph. Products which do not meet all of the criteria outlined in this document can apply for market authorization outside of the monograph stream.

Content

1. Medicinal Ingredient(s)

2. Route of Administration

3. Dosage Form(s)

4. Use(s) or Purpose(s)

5. Dose(s)

6. Duration(s) of Use

7. Risk Information

8. Non-medicinal ingredients

9. Storage conditions

10. Specifications

11. Appendix 1: Unacceptable Use(s) or Purpose(s)