Sunscreen Manufacturing in Australia: Why It’s a Specialist Field

Sunscreen is one of the most requested — and most misunderstood — categories in Australian beauty. Founders regularly ask us to add an SPF product to their range, expecting it to work like any other moisturiser or serum. It doesn’t. In Australia, sunscreen sits in a different regulatory universe to the rest of your skincare, and that changes everything about how it’s made, tested, and brought to market.

Here’s how sunscreen manufacturing actually works in Australia, why it’s a specialist field, and what it means if you’re a brand thinking about launching one.

Most sunscreens are therapeutic goods, not cosmetics

This is the fact that surprises almost everyone. In Australia, a primary sunscreen — any product whose main purpose is protecting skin from UV — is regulated by the Therapeutic Goods Administration (TGA) as a therapeutic good, not by AICIS as a cosmetic. That includes most standalone sunscreens above SPF 4.

Practically, that means a primary sunscreen has to be listed on the Australian Register of Therapeutic Goods (an AUST L number), comply with the sunscreen standard AS/NZS 2604, and be manufactured in a facility holding a TGA manufacturing licence under therapeutic-goods GMP. That is a fundamentally higher bar than the cosmetic GMP (ISO 22716) that governs a moisturiser or a cleanser.

If you’ve ever wondered why sunscreen brands talk about their formulas the way pharmaceutical companies talk about drugs, this is why. Regulators treat them the same way.

The narrow “cosmetic sunscreen” exception

There is a limited carve-out. A secondary sunscreen — where sun protection is not the product’s main purpose — can sometimes be regulated as a cosmetic instead of a therapeutic good. The classic example is a daily moisturiser or foundation that carries a low SPF as a secondary benefit, within the specific conditions set out in the Therapeutic Goods (Excluded Goods) Determination.

The conditions are tight: the SPF is capped (commonly SPF 15 or below for these secondary claims), sun protection must genuinely be secondary to the product’s primary cosmetic function, and the labelling can’t position it as a standalone sunscreen. Step outside those lines — a higher SPF, a “sunscreen” front-of-pack claim, a product that’s clearly bought for its SPF — and it’s a therapeutic good again, TGA licence and all.

This is a genuinely grey area, and getting it wrong is expensive. Brands that assume “it’s only SPF 15, it’s basically a cosmetic” and skip the regulatory check are the ones that end up recalling stock.

SPF testing is the other big hurdle

Even once the regulatory pathway is clear, a sunscreen can’t make an SPF claim without testing it — and SPF testing is unlike any other cosmetic test.

SPF is measured in-vivo, on human volunteers, under standardised international methods (ISO 24444 for SPF, ISO 24443 for broad-spectrum/UVA protection). That testing runs through specialist accredited laboratories, takes weeks, and typically costs many thousands of dollars per formulation — often more than the entire development cost of a standard skincare product. Reformulate, and in most cases you test again.

Add to that the technical difficulty of the formula itself. UV filters can be difficult to stabilise, can affect texture and finish, and have to stay effective across the product’s whole shelf life. A sunscreen that tests beautifully on day one but loses protection by month twelve has failed.

What this means if you want to launch a sunscreen

None of this is meant to scare you off — sunscreen is a strong category, and Australians buy a lot of it. But it’s worth going in with realistic expectations:

• Longer timelines. Where a custom cosmetic skincare product might reach market in four to six months, a TGA-listed sunscreen program commonly runs twelve months or more, largely because of testing and the regulatory dossier.
• Higher upfront cost. SPF testing, broad-spectrum testing, stability work, and regulatory listing add up well before your first production run.
• A specialist manufacturer. You need a facility that actually holds a TGA manufacturing licence for sunscreens. Most cosmetic contract manufacturers — us included — don’t, because cosmetic and therapeutic manufacturing are licensed separately.
• Compliance-ready labelling. Directions for use, the AUST L number, the standard’s required warnings, expiry — sunscreen labels carry obligations a cosmetic label doesn’t.

Where a cosmetic manufacturer fits — and where it doesn’t

To be straight about our own position: Epilab is a cosmetic contract manufacturer. We formulate and manufacture skincare, bath and body, hair care and pet care under cosmetic GMP, with AICIS notification handled in-house. We do not manufacture primary sunscreens, because that’s TGA-licensed territory and a genuinely different discipline.

What we can do is help you understand which side of the line your product idea sits on before you spend a cent on formulation — the same way we walk founders through the AICIS versus TGA distinction. If your “sun” product is really a cosmetic moisturiser with a secondary low-SPF benefit, that may be a conversation worth having. If it’s a genuine primary sunscreen, the honest answer is that it belongs with a TGA-licensed sunscreen manufacturer, and we’d rather tell you that up front than take you down the wrong path.

The rest of your range — the serums, cleansers, body products and everything you’d build a brand around — is exactly the work we do every day, from 500-unit pilot batches through to retail-scale runs.

The short version

Sunscreen manufacturing in Australia is a specialist, TGA-regulated field with its own licensing, its own testing, and its own timelines. Treat it like a normal cosmetic and you’ll hit a wall. Understand the regulatory line early — primary versus secondary, cosmetic versus therapeutic — and you can plan properly, whether that means partnering with a licensed sunscreen manufacturer or focusing your launch on the cosmetic products that build the brand first.

If you’re mapping out a skincare range and want to talk through where the regulatory lines fall for your specific products, Epilab offers free consultations for early-stage founders before any formulation work begins.