Information for sunscreen sponsors
Information for sponsors about sunscreen regulation, advertising and good manufacturing practice.
To do that you must ensure the sunscreen product:
- is manufactured in a TGA-approved facility
- only includes TGA-approved ingredients
- complies with the Australian Sunscreen Standard
For more information on regulatory requirements for therapeutic sunscreens refer to the Australian regulatory guidelines for sunscreens.
Some cosmetic products containing sunscreen ingredients are exempt from therapeutic goods legislation and do not need to be entered in the ARTG. Visit the Australian Industrial Chemicals Introduction Scheme to check if your product is a cosmetic.
Australian regulatory guidelines for sunscreens
The Australian regulatory guidelines for sunscreens contains information on:
- listing therapeutic sunscreens
- registering therapeutic sunscreens
- which sunscreens are exempt from TGA regulation
- the responsibility of sponsors to report adverse reactions
- advertising therapeutic sunscreens
- reproducibility of SPF test results
- stability testing
- manufacture and quality control
- permitted ingredients
- evaluation of new ingredients.
Advertising of sunscreens
Advertising must clearly position sunscreens as only being one part of sun protection. It must include prominently displayed statements or visual representations communicating:
- PROLONGED HIGH-RISK SUN EXPOSURE SHOULD BE AVOIDED
- FREQUENT USE AND RE-APPLICATION IN ACCORDANCE WITH DIRECTIONS IS REQUIRED FOR EFFECTIVE SUN PROTECTION
For more details, refer to Section 23(3) of the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021.
Good Manufacturing Practice for sunscreens
Sunscreens must be manufactured in line with the principles of Good Manufacturing Practice (GMP). Most sunscreens are low-risk topical listed products. For these, we have developed risk-based guidance on GMP compliance pathways for sunscreen manufacturers in key areas related to:
- water quality
- materials sampling
- raw material standards
- validation activities
- product quality reviews
- ongoing stability trials.
Sunscreen label requirements
The labelling and advertising of therapeutic sunscreens must comply with the relevant requirements of each of the following:
- the most current version of the Labelling Order
- the most current version of the Advertising Code
- the Australian Sunscreen Standard.
These documents include requirements such as the following:
- The main label on sunscreen packaging (containers or cartons) must include the product name and its:
- sun protection factor (SPF)
- water resistance in hours and minutes (if relevant)
- broad spectrum statement (if relevant)
- You may also state the level of protection based on the SPF:
- low protection (SPF 4, 6, 8,10)
- medium or moderate protection (SPF15, 20,25)
- high protection (SPF 30, 40,50)
- very high protection (SPF50+).
- The label must also include such things as:
- active ingredients
- dose form (cream, lotion or spray)
- net quantity of goods
- ARTG registration number (for example, AUST L 12345)
- expiry date
- batch number
- label advisory statements
- directions for use
We can monitor therapeutic sunscreens that are supplied in the market in Australia. This may be random or targeted compliance reviews and can include desk top auditing or testing of product samples available in the market place.
This monitoring program ensures sunscreens comply with relevant regulatory requirements supporting safety, quality and efficacy.