Regulation

TGA SPF reforms vs US sunscreen rules: what Australia is changing in 2026

Australia's TGA is rewriting SPF testing rules after Choice and Consumer NZ shortfalls. Here is how that compares with the US FDA sunscreen monograph approach.

2026-11-03 TGA FDA regulation

The short answer

Australia's medicines regulator, the TGA, said on 27 October 2026 that it is developing reforms to make SPF claims more reliable: finished-product and periodic testing, stronger lab oversight, ISO standards in law, and SPF claim limits for cosmetic sunscreens ^[1]^[2]. That push follows Choice's 2025 shortfalls and fresh Consumer NZ results in late October 2026 ^[1]^[3]. The US FDA still runs sunscreens mainly through its OTC monograph, with recent moves on ingredients rather than a matching finished-product SPF audit program ^[4]^[5].

What is the TGA changing?

The TGA is progressing a package of sunscreen reforms after a public consultation that ran from March to May 2026 and drew almost 120 responses ^[1]^[2]. Reporting on the TGA's published reform list and media release, the core testing changes include ^[1]^[2]:

Allowing sponsors to use in vitro or in vivo SPF testing where appropriate.
Strengthening accreditation of testing laboratories.
Putting International Organization for Standardization (ISO) SPF standards directly into legislation.
Requiring SPF testing on the finished product, not only a base formula, and again periodically while the product stays on the Australian Register of Therapeutic Goods (ARTG).
Requiring sponsors to give testing data to the TGA at listing (held in confidence).

The same package also covers ingredient quality requirements, clearer SPF claim limits for secondary (cosmetic) sunscreens, a review of sunscreen GMP guidance, and a later look at how SPF numbers are shown on labels ^[1]^[2].

These are reforms being developed, not overnight switch-flips. The TGA and ABC both note that some pieces may land sooner while others need more consultation or law changes ^[1]^[2].

Why now — Choice, Consumer NZ, and trust in the label?

Choice's 2025 testing found 16 of 20 popular Australian sunscreens missed their labelled SPF, including a product that tested around SPF 4 against a 50+ claim and sparked recalls of related formulas ^[1]^[2]. That episode battered consumer trust and pushed the TGA's investigation and reform consultation ^[1]^[2].

Then Consumer NZ published new lab results on 30 October 2026: 7 of 10 tested sunscreens failed to meet their SPF label claim ^[3]^[8]. Six of those still tested at SPF 30 or higher; one (Coola Zinc Oxide Sunscreen Lotion 50) tested at SPF 14 against a labelled SPF 50 ^[3]^[8]. All ten met broad-spectrum requirements in that test ^[3]. Consumer NZ shared the findings with New Zealand's Commerce Commission, and the results add pressure on both sides of the Tasman for tighter oversight of SPF claims ^[8].

So this post is about regulator reform and AU vs US systems, not a re-run of our earlier label vs. tested SPF guide, which focuses on Consumer Reports gaps shoppers already see on US shelves.

Finished-product testing and periodic retesting — what do they mean?

Today, according to ABC's summary of the TGA proposal, Australian makers do not have to send SPF data to the TGA unless asked ^[1]. Under the reforms being developed, brands would have to ^[1]^[2]:

Test the SPF of the finished product before listing.
Keep testing it periodically over its shelf life / while it remains on the ARTG.
Give those results to the TGA on a confidential basis at listing.

Choice welcomed finished-product testing and confidential submission to the TGA, but criticised the plan for not routinely checking that data before products hit shelves and for keeping results out of public view ^[2]. ABC and Choice, reporting the TGA reform package, frames the goal as more reliable SPF claims and faster access to evidence when problems arise — not a public SPF scoreboard ^[1]^[2].

Will Australia allow in vitro SPF testing?

Yes, as an option where appropriate. ABC reports that companies would be allowed to use an in vitro method (sunscreen on a plastic plate) alongside, not instead of, traditional in vivo volunteer testing, because the TGA is worried about variability in in vivo results ^[1]. In vivo would still be needed for some formulas and for water-resistance claims ^[1]. That sits next to stronger lab accreditation and ISO references in legislation ^[1]^[2].

What about cosmetic sunscreens and SPF makeup limits?

The TGA wants a clearer line between primary UV-protection sunscreens and secondary (cosmetic) sunscreens ^[1]^[2]. ABC notes that some cosmetic products can currently claim SPF up to 50+ without being listed as therapeutic goods, and that the reforms aim to make that distinction clearer for shoppers ^[1]. Exact numeric caps are still part of the developing package — treat them as "coming rules," not a number already printed in law.

Practical takeaway for makeup with SPF: do not treat a tinted moisturiser or foundation as your only outdoor sunscreen. Our companion guide, Is SPF makeup enough?, covers dosing and reapplication.

How does the US FDA approach differ?

The United States regulates most nonprescription sunscreens through OTC Monograph M020 (administrative orders under the CARES Act), not through an ARTG-style listing-plus-periodic-SPF-file system like the one Australia is building ^[4]^[5].

Recent US moves look different from Australia's testing package:

Topic	Australia (TGA reforms in development, Oct 2026)	United States (FDA OTC monograph)
Trigger	Choice 2025 shortfalls + Consumer NZ Oct 2026 results; consultation Mar–May 2026 ^[1]^[3]	CARES Act monograph orders; 2021 proposed order still partly open ^[4]
SPF evidence at market entry	Finished-product SPF data to regulator at listing (confidential); periodic retesting while listed ^[1]^[2]	Products marketed under monograph conditions / GRASE ingredients; proposed recordkeeping of final formulation testing in the 2021 proposed order, not yet a matching AU-style periodic SPF audit ^[4]
Test methods	In vitro or in vivo where appropriate; ISO in legislation; lab accreditation focus ^[1]^[2]	Existing US labeling/effectiveness framework; method details differ by order/rule set ^[4]
Cosmetic / secondary SPF	Clearer SPF claim limits for cosmetic sunscreens planned ^[1]^[2]	Makeup/moisturizer with SPF is regulated as both a cosmetic and a drug when SPF is claimed ^[6]
Recent ingredient action	Ingredient quality requirements to be developed ^[1]^[2]	Final order Sep 10, 2026 removed PABA and trolamine salicylate from Monograph M020; Jun 2026 order added bemotrizinol (BEMT) ^[4]^[5]

FDA's September 2026 final order on PABA and trolamine salicylate is a safety-based ingredient removal. FDA says it is not aware of US products currently sold with those actives, and consumers need take no action ^[4]^[5]. Broader 2021 proposed-order topics (max labelled SPF, dosage forms, broad-spectrum mandates, labeling layout) remain for future orders ^[4].

For US ingredient news we already covered, see bemotrizinol (BEMT). For reading the US Drug Facts box, see our Drug Facts guide.

What should Australian vs US shoppers do right now?

In Australia / New Zealand: Keep using SPF 30+ sunscreen as part of shade, clothing, and hat habits — Consumer NZ still pushes that message even after its shortfalls ^[3]. Prefer well-known therapeutic sunscreens over vague "sun protective" makeup claims while cosmetic SPF limits are still being rewritten ^[1]^[2]. Independent lab shortfalls (Choice, Consumer NZ) are a reason to favour well-tested formulas, not a reason to skip sunscreen ^[1]^[3]^[8].

In the United States: Buy broad-spectrum SPF 30+ products and check the Drug Facts box ^[7]. Prefer products with strong independent lab results when you can find them — that is how we build our rankings and why we publish how we rank by verified SPF. Do not wait for a future FDA order to wear sunscreen outdoors ^[4]^[7].

Affiliate note for this site: our US Amazon tag (`worldofsunscr-20`) is live; a UK tag is still TBD, so UK/AU locale storefronts stay off.

This article is general information about regulation and testing, not medical advice. Ask a doctor or dermatologist about sun protection for babies under 6 months or for skin conditions.

FAQ

Are the TGA reforms already law?

No. The TGA is developing and staging the reforms after consultation. Some may arrive sooner; others need more consultation or legislative change ^[1]^[2].

Did Consumer NZ say those sunscreens give zero protection?

No. Six of the seven that missed their label still tested at SPF 30 or higher. Only one tested at low protection (SPF 14) in that set ^[3]^[8]. A missed label claim is still a serious trust problem, but it is not the same as "zero protection" for every product in the set ^[3].

Is the US removing sunscreens from shelves over PABA?

FDA removed PABA and trolamine salicylate from the OTC sunscreen monograph on 10 September 2026, but says it knows of no US products currently sold with those ingredients, so shoppers need take no action ^[4]^[5].

Will Australian SPF test results become public?

Not under the current proposal described by ABC and Choice. Results would go to the TGA confidentially; Choice has argued they should be public and routinely checked ^[1]^[2].

How is this different from "label SPF vs tested SPF"?

That earlier guide explains Consumer Reports-style gaps between front labels and lab averages. This article compares regulator reform programs (TGA package vs FDA monograph) and what shoppers in each system should watch for.