Sunscreen, guidelines & publications

Legislation for excluded sunscreens (e.g. cosmetic sunscreens)

• Industrial Chemicals Act 2019
• Consumer Goods (Cosmetics) Information Standard 2020

Guidance for therapeutic sunscreens

• Australian Regulatory Guidelines for Sunscreens
• Listed therapeutic sunscreens: Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines
• Registered therapeutic sunscreens: Australian Regulatory Guidelines for OTC Medicines

Guidance on test methods for therapeutic sunscreens

• International scientific guidelines adopted in Australia
• Guideline on the principles of regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches
• OECD Test guidelines for the Chemicals
• The European Commission's Tracking System for Alternative methods towards Regulatory acceptance (TSAR)
• The European Commission's science and knowledge service
• www.cir-safety.org
• The SCCS notes of guidance for the testing of cosmetic ingredients and their safety evaluation 10th revision

Guidance for manufacturing of therapeutic sunscreens

• Manufacturing principles for medicinal products
• Sunscreen manufacturing: Demonstrating compliance with the PIC/S guide to GMP, PE0009-13.
• GMP clearance
• Release for supply of medicines

Information on specific ingredients in therapeutic sunscreens

• Regulation (EC) No. 1223/2009A literature review by the TGA on the safety of titanium dioxide and zinc oxide nanoparticles in sunscreens