Cosmetic or Therapeutic? TGA Rules and Skincare Claims in Australia
Most skincare sold in Australia is a cosmetic, and cosmetics are not regulated by the TGA. A skincare product becomes a therapeutic good, and a TGA matter, when it's presented for a therapeutic use: preventing, treating or curing a condition, or changing how the body works. The biggest trigger is what you claim, on the label and in your marketing, but ingredients and how the product is used count too. Get it wrong and the product must be on the Australian Register of Therapeutic Goods (ARTG) before it can be sold or advertised.
Key facts
- Cosmetics are regulated by the ACCC (Australian Consumer Law, product safety and ingredient labelling), AICIS (ingredients) and the Poisons Standard (ingredient limits).
- The TGA regulates therapeutic goods. A therapeutic good must be on the ARTG before it's supplied or advertised, unless an exemption applies.
- The TGA looks at four things together: claims, ingredients, how the product is used, and whether it's an excluded good.
- Claims include the product name, label, website, ads, social posts, images and reviews you share.
- "TGA approved" or "TGA compliant" is not something a cosmetic can claim.
Who regulates cosmetics in Australia?
Several regulators share the job, and none of them approves a cosmetic before it goes on sale. Responsibility for getting it right sits with the business that supplies it.
| Regulator | What it covers for skincare |
|---|---|
| ACCC | Product safety, the claims you make (they must not be false or misleading under the Australian Consumer Law), and ingredient labelling under the Consumer Goods (Cosmetics) Information Standard 2020. |
| AICIS | The ingredients. Cosmetic ingredients are industrial chemicals under the Industrial Chemicals Act 2019, so importers and manufacturers of them must register. AICIS doesn't regulate finished products, labels or advertising. |
| Poisons Standard | Limits and labelling for certain ingredients. The TGA maintains it and the states and territories enforce it. |
| TGA | Therapeutic goods only: medicines, medical devices, most sunscreens and anything presented for a therapeutic use. |
The four tests: is your product a cosmetic or a therapeutic good?
A cosmetic is something applied to the outside of the body (or inside the mouth) to change its appearance or odour, cleanse it, keep it in good condition or protect it. The TGA weighs four factors together rather than one at a time.
1. The claims you make
This is the factor that matters most for a skincare brand. Claims about how skin looks or feels are cosmetic. Claims about treating a condition, or changing a process inside the skin, are therapeutic. The TGA's own examples follow the same pattern: "looks firmer" is cosmetic, but "rebuilds the skin's internal structure" is therapeutic.
Context counts as well as words. A moisturiser that "soothes dry skin" is a cosmetic claim, but the same line next to photos of psoriasis, or on a site aimed at people with a skin condition, can make the product read as a treatment.
2. The ingredients
Some ingredients make a product therapeutic regardless of the claims. Anything containing an ingredient in Schedule 2, 3, 4 or 8 of the Poisons Standard is likely to be a therapeutic good; skin-lightening lotions with hydroquinone are a common example. Concentration can matter too: an ingredient may be fine at a cosmetic level but scheduled above a limit.
3. How it's used
Cosmetics are only for the outside of the body or the mouth. A beauty product that's swallowed, such as a collagen drink or skin supplement with beauty claims, is declared a therapeutic good, and so is anything injected.
4. Whether it's an excluded good
The Therapeutic Goods (Excluded Goods) Determination 2018 carves some products out of therapeutic regulation if they meet its conditions. Examples relevant to skincare brands include:
- anti-acne products that work only by cleansing, moisturising, exfoliating or drying the skin;
- anti-dandruff products that work only by cleansing, moisturising, exfoliating or drying the scalp;
- moisturisers, tinted bases and foundations, lip balms and tanning products with a sunscreen that meet the conditions (for moisturisers and tanning products, no SPF claim above 15);
- non-medicated soaps and detergents for cleansing skin or hair.
If a product doesn't meet every condition in the Determination, it isn't excluded and the normal therapeutic rules apply.
Claims that make skincare a therapeutic good
The TGA lists product types that are likely to be therapeutic because of what they claim. For skin, hair and lash products, watch for claims that:
- treat or relieve a skin condition: acne and pimples, eczema, psoriasis, rosacea, scarring, burns or sunburn;
- relieve pain or inflammation;
- are antibacterial, antiseptic, antiviral or antifungal;
- heal or repair damaged skin by regenerating skin cells;
- promote hair growth or reduce hair loss;
- control dandruff by any means other than cleansing, moisturising, exfoliating or drying;
- provide sun protection as the main purpose (primary sunscreens).
Safer cosmetic wording: examples
You can usually describe the same product benefit in cosmetic terms by talking about appearance and feel. These are our suggestions, not TGA-approved wording, so always read the whole label and ad in context.
| Avoid (therapeutic) | Use instead (cosmetic) |
|---|---|
| Treats acne / clears breakouts | For oily, blemish-prone skin; deep-cleanses pores; absorbs excess oil |
| Stimulates collagen production | Smooths the look of fine lines; skin looks firmer |
| Heals / repairs damaged skin | Moisturises and comforts dry skin; helps keep skin in good condition |
| Reduces pigmentation | Helps skin look brighter and more even |
| Anti-inflammatory / reduces redness | Calms the look of redness; soothing feel |
| Antibacterial / kills germs | Gently cleanses; leaves skin feeling fresh |
| Promotes lash growth | For longer, fuller-looking lashes; conditions lashes |
| Relieves muscle pain | Cooling, warming massage cream |
| Regenerates skin cells | Revitalises the look of tired skin |
Cosmetic wording still has to be true. Under the Australian Consumer Law you need to be able to back up any claim you make, and "clinically proven" or percentages ("87% saw results") need evidence behind them.
What about sunscreen?
Products whose main purpose is sun protection (primary sunscreens) are therapeutic goods. A moisturiser or foundation with sun protection as a secondary benefit can be an excluded good if it meets the Determination's conditions, including not claiming more than SPF 15 for moisturisers. Any SPF claim needs testing to AS/NZS 2604. Don't add "SPF" to a label unless the formula has been tested for it.
Common mistakes we see
- The product name makes the claim. "Acne Clear Serum" or "Eczema Cream" is a therapeutic claim even if the rest of the label is careful.
- Social posts and reviews go further than the label. Reposting a customer's "this cured my rosacea" is your claim too.
- Before-and-after photos of a condition. Images of acne or eczema imply treatment.
- "TGA approved" or "TGA compliant". Cosmetics aren't approved by the TGA, so this is misleading.
- Copying overseas copy. US "drug facts" style claims and EU marketing don't map neatly onto Australian rules.
How we handle this for white label and private label clients
Everything we make is a cosmetic. We don't make therapeutic goods such as primary sunscreens or medicated products. For custom formulas we review your brief against the rules in each market you'll sell in (AICIS and the Poisons Standard in Australia, plus the EU, UK and US) before development starts and flag any claim or ingredient issues. For white label products, our Label guide sets out the claims you can and can't make and the mandatory label elements, and our regulatory guide by market covers selling overseas.
You're responsible for the final claims on your label, website and ads, because they're your brand's claims. If you're unsure about a claim, the TGA has an online tool, "Is my product a therapeutic good?", and AICIS has "Is my product a cosmetic?". For anything borderline, get advice from a regulatory consultant before you print.
Frequently asked questions
Does the TGA regulate cosmetics?
No. Cosmetics are regulated by the ACCC, AICIS and the Poisons Standard. The TGA regulates therapeutic goods, so it only becomes involved when a skincare product is presented for a therapeutic use or contains therapeutic ingredients.
Can I say my skincare is "TGA approved"?
Not for a cosmetic. The TGA doesn't approve cosmetics, so "TGA approved", "TGA listed" or "TGA compliant" would be misleading.
Is an anti-acne cleanser a cosmetic?
It can be, if it's an excluded good: it must work only by cleansing, moisturising, exfoliating or drying the skin, and meet the other conditions in the Excluded Goods Determination. Claims that it treats or prevents acne in other ways make it therapeutic.
Can I use the word "repair"?
Be careful. Healing or repairing damaged skin through regenerating skin cells is on the TGA's list of therapeutic claims. Phrases about moisturising, comforting or keeping skin in good condition are safer.
What happens if my product is a therapeutic good?
It must be entered on the ARTG before you import, supply, export or advertise it, and therapeutic advertising has its own code. Supplying or advertising an unapproved therapeutic good can lead to significant fines.
This article is general information, not legal advice.
Sources: Therapeutic Goods Administration, Determining if your product is a cosmetic or therapeutic good (updated 3 July 2026); ACCC Product Safety, Cosmetics ingredients labelling mandatory standard; Therapeutic Goods (Excluded Goods) Determination 2018; Therapeutic Goods (Declared Goods) Order 2019.
Related: How to start a skincare brand in Australia | Label guide
