Canberra, Australia, 3 November 2026 — Australia's Therapeutic Goods Administration (TGA) is developing tougher sunscreen requirements covering sun protection factor (SPF) testing, ingredient quality, and SPF claims for cosmetic products with sunscreen functions. The agency confirmed its reform directions on 27 October 2026 after reviewing stakeholder feedback between May and October.
The reforms could affect therapeutic sunscreen manufacturers and sponsors—Australian companies legally responsible for supplying these products—as well as businesses selling SPF-rated moisturizers, foundations, and lip products. Specific regulatory requirements are now being developed, with no implementation dates announced.
Stronger Testing and Oversight of Sunscreen Performance
The TGA's review identified concerns about inconsistent SPF results, laboratory reliability, ingredient quality, and manufacturers' understanding of regulatory obligations. It considered international testing developments, the regulator's own investigations, and independent findings, including CHOICE's June 2025 testing, in which 16 of 20 sunscreens failed to achieve their advertised SPF ratings.
Following its March–May 2026 consultation, the TGA selected five directions for strengthening SPF testing:
Finished-product testing: Require SPF testing on finished sunscreens when listed in the Australian Register of Therapeutic Goods (ARTG), followed by periodic verification.
SPF evidence: Require sponsors to submit test results at listing, with the information held confidentially by the TGA.
Laboratory oversight: Strengthen accreditation and oversight of SPF testing laboratories.
Testing methods: Permit appropriate laboratory-based (in vitro) and human-subject (in vivo) testing.
International standards: Reference International Organization for Standardization (ISO) testing standards directly in legislation.
The March 2026 consultation identifies ISO 23675:2024 and ISO 23698:2024 as newer SPF assessment methods.
These measures could require sponsors to obtain testing evidence for finished commercial formulations and maintain documentation supporting SPF claims throughout a sunscreen's market life.
Ingredient Quality and Manufacturing Controls
The TGA also intends to establish specific quality requirements for sunscreen ingredients. Its consultation identifies zinc oxide as an example where characteristics such as particle size can influence sunscreen performance but are not fully addressed by existing ingredient specifications.
The regulator will also revise sunscreen good manufacturing practice (GMP) guidance to clarify manufacturer and sponsor responsibilities.
Depending on the eventual requirements, manufacturers may need to strengthen ingredient specifications, review supplier documentation, and improve controls intended to ensure consistent product performance.
Consistent SPF Limits for Cosmetic Sunscreens
The TGA plans to establish a consistent SPF claim limit for secondary cosmetic sunscreens—products such as moisturizers, tinted foundations, and lip products that provide sun protection as an additional function.
Current exclusions from therapeutic goods regulation permit certain moisturizers to claim SPF 15 or less, while eligible tinted foundations and lip products may carry claims up to SPF 50+.
The new limit has not yet been determined. Affected businesses may eventually need to revise SPF claims, update labels, or reassess whether their products qualify for exclusion from therapeutic goods regulation.
Separately, the TGA has deferred decisions on broader SPF labeling changes pending further consultation.
New Testing Findings Add Pressure for Reform
On 30 October 2026, Australian consumer advocacy group CHOICE reported findings from New Zealand consumer organization Consumer NZ showing that six of seven sunscreens available in Australia fell short of their SPF 50+ claims, although all six achieved measured SPF values of at least 30.
In its 30 October statement, the TGA said it would assess whether further investigation or regulatory action was warranted, noting that individual SPF test results must be considered alongside other supporting evidence because of testing variability.
The additional findings may reinforce the case for moving ahead with the selected reforms, particularly finished-product testing and ongoing SPF verification. However, the TGA has not announced any acceleration of its regulatory timetable in response.