The sunscreen sitting on a pharmacy shelf in Sydney is not the same product you'd find in a CVS in Chicago or a pharmacy in Paris, and not just because of the label. The formulas, UV filters, and testing standards they had to pass are different. For most consumers, sunscreen is sunscreen. You squeeze it on, rub it in, and hope for the best. But behind every bottle sits a regulatory framework that determines which UV-blocking ingredients are allowed and how rigorously the product must be tested. These frameworks vary dramatically between Australia's Therapeutic Goods Administration (TGA), the United States Food and Drug Administration (FDA), and the European Union's cosmetic regulatory system, and the differences have real consequences for the protection you receive. Understanding this three-way regulatory divergence matters whether you're a traveller stocking up on sunscreen abroad.

The Classification Split: Drug, Cosmetic, or Therapeutic Good

In Australia, sunscreens that make therapeutic claims about sun protection are classified as therapeutic goods under the Therapeutic Goods Act 1989. This places them under pharmaceutical-level oversight by the TGA. Products must be listed on the Australian Register of Therapeutic Goods (ARTG) and carry an AUST L number on the label before they can legally be sold. Manufacturing must occur in TGA-licensed facilities in accordance with pharmaceutical-grade Good Manufacturing Practice (GMP), with strict quality control at every stage of production.

In the United States, sunscreens are regulated as over-the-counter (OTC) drugs under the FDA's monograph system. The FDA treats them as drug products because they make claims to prevent sunburn, reduce the risk of skin cancer, and slow premature ageing. This means sunscreens must comply with the OTC drug monograph, which is a regulatory framework that dictates which active ingredients are permitted, at what concentrations, and with what labelling.

The European Union takes a fundamentally different path. Under Regulation (EC) 1223/2009, sunscreens are classified as cosmetic products. While this might sound like lighter regulation, the EU system compensates with its own rigorous set of requirements: only UV filters listed in Annex VI of the regulation are permitted, each with specified maximum concentrations and designated product types. The European Commission has also issued specific labelling and claims requirements. For instance, banning claims such as "total protection" or "sun blocker" prevents consumers from overestimating a product's capabilities. This classification difference directly determines how quickly new UV filter ingredients can enter the market and how aggressively regulators can act when problems emerge.

The UV Filter Gap: A Decades-Long Divergence

The FDA's current OTC monograph lists 16 approved UV filters, and it hasn't added a new one since 1999. Of those 16, only two mineral filters, zinc oxide and titanium dioxide, have achieved GRASE (Generally Recognised as Safe and Effective) status. The remaining 14 chemical filters are categorised as needing additional safety data, effectively leaving them in regulatory limbo. Meanwhile, several of these older filters have come under scrutiny. The European Commission has identified endocrine-disrupting properties in oxybenzone and homosalate, recommending maximum concentrations of 2.2% and 0.5%, vastly lower than the U.S. limits of 6% and 15%.

Australia and the EU have been far more progressive. Both jurisdictions approve a broader range of modern UV filters, including advanced ingredients such as bemotrizinol (marketed as Tinosorb S), which provides broad-spectrum UVA and UVB protection with high photostability and minimal systemic absorption. Bemotrizinol has been approved in the EU since 2000 and has been available in Australia for years. It wasn't until December 2025 that the FDA finally issued a proposed administrative order to add bemotrizinol to the U.S. monograph, potentially the first new OTC sunscreen active ingredient authorised in over 25 years.

The TGA recently approved another advanced filter, tris-biphenyl triazine, adding it to the list of permitted active ingredients. The EU similarly maintains a dynamic Annex VI that can be updated as new safety and efficacy data emerge, without requiring the years-long legislative process that has historically bottlenecked FDA approvals.

This filter gap has measurable consequences. Tested U.S. sunscreens delivered only 42% to 59% of their labelled SPF values in vitro, and provided just 24% of labelled UVA protection. The limited filter toolkit available to American formulators makes it harder to build formulas that deliver photostable broad-spectrum protection.

Testing Standards: Where Rigour Meets Reality

Australia's AS/NZS 2604 Standard

Australia and New Zealand follow the AS/NZS 2604:2021 standard, which sets out procedures for evaluating and classifying all sunscreen products. Since July 2024, all new sunscreen products listed on the ARTG must comply with this updated standard. The testing is extensive, with SPF determination requiring in vivo testing on a minimum of 10 human volunteers under controlled laboratory conditions. Broad-spectrum testing follows the ISO 24443 in vitro method. Water resistance testing, if claimed, requires the sunscreen to maintain its SPF rating after up to 240 minutes (four hours) of water immersion. 

Critically, the TGA also conducts post-market surveillance. This was put to the test in mid-2025, when the consumer advocacy group CHOICE published findings that 16 of 20 tested sunscreens did not meet their claimed SPF 50+ ratings. The TGA launched an investigation into every product flagged and is now reviewing existing SPF testing requirements, including exploring in vitro test methods that may be more reliable and reproducible.

The FDA's Approach

The FDA requires in vivo SPF testing on human subjects, broadly similar to Australia's approach. Broad-spectrum claims must meet the critical wavelength test. The product must achieve a critical wavelength of at least 370 nm after UV exposure. Water resistance is tested at either 40 or 80 minutes, considerably shorter than Australia's four-hour threshold. One notable quirk of the U.S. system is that brands can print the exact SPF number their product was tested at — SPF 46, SPF 72, SPF 100. Australia restricts labelling to specific permitted values (4, 6, 8, 10, 15, 20, 25, 30, 40, 50, and 50+), with the rationale that marginal differences at high SPF numbers create a false sense of proportionally greater protection.

EU Testing Protocols

The EU uses the ISO 24444 method for in vivo SPF testing and ISO 24443 for in vitro UVA assessment. The EU goes further than the FDA on UVA by requiring the UVA Protection Factor (UVA-PF) to be at least one-third of the labelled SPF. This ensures that products cannot market high SPF numbers without delivering proportional UVA coverage, a requirement that prevents the "high SPF, low UVA" formulation loophole. Two new ISO testing standards were published in 2025: ISO 23675 for in vitro SPF determination and ISO 23698 for diffuse reflectance spectroscopy measurement, signaling a global shift toward supplementing human testing with more reproducible laboratory methods.

Why Australia's Framework Is Uniquely Demanding

Australia has the highest age-standardised melanoma incidence rate in the world, 36.6 per 100,000 people as of 2020, according to global cancer statistics. Two in three Australians will be diagnosed with some form of skin cancer by age 70. During summer, Australia's UV index routinely sits between 10 and 14, well into the "extreme" category. The southern hemisphere receives approximately 15% more UV radiation than equivalent northern latitudes, a factor of orbital mechanics and atmospheric composition rather than ozone depletion. 

This environment has driven regulatory stringency. The TGA's pharmaceutical-level classification means sunscreens must meet the same manufacturing standards as listed medicines. Broad-spectrum protection isn't optional. A product cannot be listed on the ARTG if it does not protect against both UVA and UVB radiation. Water-resistance testing at 4 hours exceeds any other major jurisdiction's requirements.

Australia is also home to the world's most important body of evidence on sunscreen efficacy: the Nambour trial. This landmark randomised controlled trial, conducted in Queensland from 1992 and followed up through 2006, randomly assigned 1,621 residents to daily or discretionary sunscreen use. The results showed that daily sunscreen users had roughly half the rate of new primary melanomas compared to non-users. For invasive melanomas specifically, the hazard ratio was 0.27, a 73% reduction. This trial remains the gold-standard evidence that sunscreen prevents melanoma, and its Australian origin has deeply influenced the TGA's regulatory posture.

This demanding regulatory environment shapes the brands that emerge from it. Consider Standard Procedure, an Australian-made sun care brand born from multi-generational sunscreen manufacturing expertise. Founded by Zepha Jackson, whose family has run a topical skincare factory for over 40 years, and professional surfer Dion Agius, the brand produces SPF 50+ products in a solar-powered facility on Queensland's Sunshine Coast. Every product is tested to the AS/NZS 2604 standard and formulated for four-hour water resistance, while excluding oxybenzone and octinoxate in line with the TGA's precautionary direction on those ingredients.

Ingredient Safety: Three Regulatory Bodies, Three Speeds

The way each regulator handles emerging safety concerns about existing UV filters reveals fundamental differences in risk tolerance and precautionary philosophy:

 

• The EU has moved fastest. As of May 2025, 4-MBC (4-Methylbenzylidene Camphor) is banned, with a complete product withdrawal deadline of May 2026. Homosalate has been restricted to face-only products at a maximum concentration of 7.34% since January 2025. The European Commission's Scientific Committee on Consumer Safety (SCCS) has driven these changes based on data on endocrine disruption.
• The TGA has taken a measured but active approach. It has recommended regulatory controls for both homosalate and oxybenzone to restrict their permitted concentrations in therapeutic sunscreens. These proposals are described as precautionary measures based on potential signals from animal studies rather than human data. Interim decisions have been progressing through public consultation in 2026. The TGA is also reviewing 4-MBC but has not yet issued a recommendation. Additionally, the TGA has introduced the Australian Sunscreen Exposure Model (ASEM) to calculate safe concentrations of new ingredients that can be absorbed through the skin.
• The FDA has been the slowest. While the FDA acknowledged in 2019 that only zinc oxide and titanium dioxide are GRASE, the remaining chemical filters still lack final safety determinations. The December 2025 proposal to add bemotrizinol was based on over two decades of international use data before the FDA acted. The broader OMUFA reauthorisation through 2030, including provisions from the SAFE Sunscreen Standards Act, aims to reform the approval process, but structural change remains slow.

 

This three-speed dynamic creates a situation where a sunscreen formula perfectly compliant in the EU may contain a restricted ingredient in Australia and be fully permitted in the U.S., or vice versa. For global brands, navigating this patchwork is a significant formulation and regulatory challenge.

What This Means for Consumers

If you buy sunscreen in the U.S., you're choosing from products limited to 16 approved active ingredients, most of which date to the 1990s or earlier. Your broad-spectrum protection relies on a critical wavelength test that sets a lower bar for UVA protection than the EU's one-third UVA-PF rule. And the high SPF numbers on the shelf may offer marginal UVB gains while potentially masking weaker UVA performance.

If you buy in the EU, you're accessing a broader range of modern UV filters with strong photostability profiles, your UVA protection is guaranteed to be proportional to the SPF, and ingredients flagged for endocrine disruption have already been restricted or banned. 

If you buy in Australia, you're getting a product that has been regulated to pharmaceutical standards, tested on human volunteers, required to deliver broad-spectrum protection as a non-negotiable baseline, and manufactured in facilities held to GMP standards. The trade-off is a more limited range of labelling because you won't see SPF numbers above 50+, but the intent is better-informed consumers, not bigger numbers. 

The TGA's development of the Australian Sunscreen Exposure Model (ASEM) to assess the safety of new ingredients could also influence global approaches. As regulators everywhere grapple with systemic absorption data and endocrine disruption signals, quantitative exposure modelling may become the standard approach rather than an Australian innovation.

What seems unlikely to change is the fundamental classification split. Australia and the U.S. will continue to regulate sunscreens as therapeutic goods or drugs, respectively, while the EU maintains its cosmetic framework. These reflect deeply embedded regulatory traditions and divergent philosophies about the burden of proof required before a sun protection product reaches consumers' skin. For Australians, the regulatory system they live under is among the world's most rigorous for good reason. In a country where the UV index regularly hits extreme levels and skin cancer rates lead the globe, classifying sunscreen as a therapeutic good is the correct regulatory response.

 

Sources:

• TGA — Sunscreen Regulation in Australia
• TGA — Understanding the Regulation of Therapeutic Sunscreens
• TGA — Sunscreen Ingredients
• TGA — Updates to the Sunscreen Standard
• TGA — Sunscreen SPF Testing Information for Consumers
• FDA — Proposed Order to Add Bemotrizinol to OTC Sunscreen Monograph (Federal Register, December 2025)
• Dermatology Times — FDA Proposes Expansion of US Sunscreen Ingredient Standards with Bemotrizinol
• Holland & Knight — FDA Proposes First New Sunscreen Ingredient in Decades
• PMC — Modernizing U.S. Sunscreen Regulations: How Newer Filters Can Improve Public Health
• EU Cosmetics Regulation (EC) 1223/2009
• European Commission — Sunscreen Products
• ECHA — Cosmetics UV Filters
• Intertek — Navigating EU Regulations for Sunscreen Products
• ISO 24443:2021 — Determination of Sunscreen UVA Photoprotection In Vitro
• Journal of Clinical Oncology — Reduced Melanoma After Regular Sunscreen Use: Randomized Trial Follow-Up (Nambour Trial)
• Cancer Council Australia — Sunscreen Research and Facts
• Cancer Council WA — Why Does Australia Have So Much Skin Cancer?
• ARPANSA — Sun Protection Using Sunscreens
• Lab Muffin Beauty Science — What's the Deal with Australian Sunscreen?
• CHOICE — We Tested the SPF Claims of 20 Sunscreens. 16 Failed.
• Beauty Independent — Standard Procedure Could Be Australia's Hottest Beauty Export