14.06.2025

TGA vs FDA Sunscreen Certifications

When it comes to protecting your skin, the quality of your sunscreen matters immensely. While SPF numbers are the most visible measure, they only tell part of the story. Behind each product is a robust world of scientific validation and regulatory processes. These regulatory processes ensure sunscreens not only deliver on protection but do so with uncompromising safety and efficacy. Yet, the differences between global regulatory standards such as Australia’s TGA and the USA’s FDA are often not widely understood.  

At Emma Lewisham, every product in our Emma Lewisham Sunceutical SPF 50 Mineral range is certified by both the Therapeutic Goods Administration (TGA) in Australia and the USA Food and Drug Administration (FDA). Unlike many global brands that create region-specific SPF formulas, ours remains exactly the same—globally. So why do some brands formulate differently for different regions and what sets global certifications like the TGA and FDA apart? 

TGA vs FDA Sunscreen Certifications

TGA vs FDA Sunscreen Certifications

TGA

Australia experiences some of the highest levels of UV radiation in the world, which is due to its close distance to the equator and the ozone layer depletion in the Southern Hemisphere. This environmental reality has driven the TGA to develop what is widely regarded one of the most comprehensive regulatory frameworks for sunscreens globally.  

In Australia, sunscreens with an SPF of 4 or higher are legally classified as therapeutic goods, meaning they are regulated similarly to medicines. This means they must meet strict safety, efficacy, and quality requirements under the Therapeutic Goods Act 1989. Only pre-approved UV filters, proven through extensive toxicological data, are allowed in suncare formulations.

Every formulation must pass rigorous testing in line with the Australian/New Zealand Sunscreen Standard (AS/NZS 2604), which assesses SPF performance, broad-spectrum protection, and photostability under real-world conditions. Earning TGA certification is notoriously demanding, with one of the strictest regulatory frameworks in the world, leaving no margin for compromise on formulation integrity or testing accuracy. 

This level of scrutiny ensures that when you see Australia's gold standard TGA certification – marked by “AUST L” or “AUST R” —you can trust you’re using one of the most scientifically validated sun protection products available globally. 

FDA

In the United States, the FDA also classifies sunscreens as over-the-counter (OTC) drugs, regulated under the Code of Federal Regulations (21 CFR 201.327). Its framework is robust, requiring SPF verification, broad-spectrum testing, and ingredient safety validation.

However, the FDA's approval pathway for new sunscreen filters has historically taken more time due to a law from 1938 that requires extensive safety data. This has created barriers for the introduction of newer-generation UV filters, particularly those already approved and widely used in Europe, Japan, and South Korea for their superior UVA protection.

In fact, the FDA hasn't approved a new sunscreen filter since the 1990's. As of the 10th of April 2025, the FDA has announced it will take steps to help streamline the approval process for new filters, however, the approval of next-generation SPF filters will still take time.  

As a result, many US sunscreens are limited in the filters they can use—prompting some global brands to reformulate their products for the US market using older or less advanced ingredients. This can leave customers in the US unknowingly using formulations that fall behind modern global benchmarks, lacking access to the latest advancements in SPF filter technology.

Emma Lewisham Sunceutical Dual Certification  

At Emma Lewisham, we do not believe in compromise. Our SPF 50 range is one formulation, certified by both the TGA and FDA.  

Across our SPF 50 range, we use Zinc Oxide as the sole mineral UV filter—an SPF active that is widely recognised by both the TGA and FDA as safe and highly effective. While Zinc Oxide is known for its broad-spectrum protection, a common drawback is its tendency to leave a white cast on the skin. We’ve overcome this through our advanced dispersion technology that combines a carefully curated system of ingredients, minimising white cast while maximising sun protection. This innovation enhances the skin feel, allowing us to meet the highest SPF standards without compromising on wearability or efficacy. 

Having these certifications are a crucial stamp of approval from two of the world's most demanding regulatory bodies—the Therapeutic Goods Administration in Australia and the US Food and Drug Administration. Achieving approval from both is no small feat: it requires rigorous, science-backed testing to verify the quality, safety, and efficacy of every component.

The TGA in particular, holds some of the strictest standards globally, given that Australia is one of the most sun-exposed countries in the world, with some of the highest UV levels globally. The Emma Lewisham Sunceutical SPF 50 mineral range specifically formulated to perform under these extreme conditions, making it highly protective and high performing. 

What makes this especially significant is that our SPF 50 range remains consistent across all markets. Unlike many brands that reformulate for US regulations—often downgrading protection—we deliver the exact same globally approved formula to every customer. This means our US customers can have confidence they’re using the same high-performing SPF 50 formulation that meets Australia’s rigorous regulatory standards for sun protection.  

Formulated with a complementary system of ingredients, the SPF 50 range features multifunctional products that go beyond traditional sun protection. With a focus on quality, safety, and efficacy, these products show our commitment to innovation to meet the highest standards for sun care products.

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