Can a cream be a TGA-listed medicine?

Yes. A kava pain relief cream we developed is a TGA-listed medicine: we built its claims evidence, secured the listing and updated it after a preservative change, and designed its stability program.

Do you work on sunscreens?

Yes. For an international professional skincare brand we did the formula and evidence work on a sunscreen and two supplements, with stability studies out to 36 months.

Can one range have cosmetics and medicines in it?

Yes. Vitable's hair range pairs a TGA-listed capsule with a serum on the cosmetics pathway, and we managed manufacturing for both.

Do you handle regulatory work for a range that's already on the market?

Yes. Since 2024 we have run an international skincare brand's Australian regulatory work on a monthly retainer, now in its third year.

Do I need to register with AICIS?

If your business imports cosmetics or cosmetic ingredients into Australia, or makes a chemical for sale, generally yes, for each registration year (1 September to 31 August) in which it does. AICIS registers the business, not each product. A business that buys all its ingredients from Australian suppliers to blend doesn't need to register for that. More in our AICIS registration guide.

When is an SPF moisturiser a cosmetic?

Only if it meets every condition in the Excluded Goods Determination: SPF 4 to 15, a pack of 300 mL or 300 g or less, not water resistant, no therapeutic claims beyond premature ageing from the sun, no Schedule 2, 3, 4 or 8 poisons, an expiry date if it isn't stable for at least 36 months, and the AS/NZS 2604:2021 requirements. If it misses any of them it is a therapeutic sunscreen, which generally must be on the ARTG.

Does a cosmetic need TGA approval?

No. A product that is only a cosmetic isn't on the ARTG and has no TGA approval step. It must still meet consumer law, the ingredient labelling standard and, for the business, AICIS registration where that applies. If its claims or ingredients make it a therapeutic good, the TGA rules apply instead.

Can a skincare product claim to treat acne?

Claims to treat acne will likely make it a therapeutic good. The Excluded Goods Determination keeps an acne product out of the medicines rules only if it is presented as controlling acne by cleansing, moisturising, exfoliating or drying the skin, with no Schedule 2, 3, 4 or 8 poisons. "Helps skin look clearer" is a cosmetic claim; "treats acne" is a therapeutic one.

Skincare and cosmetics

Skincare, sunscreen and cosmetic product development

We develop creams, serums and sunscreens on the cosmetics pathway or as TGA-listed medicines, settle which one the claims put them on, and manage their manufacture through cGMP partners through to your warehouse.

Guide

AICIS guide

What AICIS is, which cosmetics and skincare businesses must register, what registration costs in 2026–27, and where the TGA and labelling rules come in.

In Australia a cream, serum or lotion is a cosmetic while its claims stay cosmetic: appearance, cleansing, odour, and protecting the skin or keeping it in good condition.
A therapeutic claim, a scheduled poison or the way it is used makes it a therapeutic good, regulated by the TGA.
A primary sunscreen is a therapeutic good; an SPF 4 to 15 moisturiser can stay a cosmetic if it meets every condition of the Excluded Goods Determination.
A business that imports cosmetics or their ingredients, or makes a chemical for sale, generally registers with AICIS each year it does.

Cosmetic or medicine: the claim decides

A cream, serum or lotion is a cosmetic in Australia while it only changes how the skin looks, cleanses it, perfumes it, protects it or keeps it in good condition. It becomes a therapeutic good, regulated by the TGA, when its claims, its ingredients or the way it is used say it does more. The TGA's own examples:

A cosmetic claim	A therapeutic claim
"Helps your skin look even and smooth"	"Reduces skin pigmentation and uneven skin tone"
"Helps skin look firm"	"Improves skin's internal structure for firmer skin"
Contains collagen "to smooth the appearance of fine lines"	Stimulates "collagen production to repair skin at the cellular level"

Images and context count as well as words. Claims to treat acne, eczema, psoriasis, rosacea, scarring or burns, or to promote hair growth, will likely make a product a therapeutic good unless it is excluded, and so will an ingredient from Schedule 2, 3, 4 or 8 of the Poisons Standard. Anti-wrinkle and anti-ageing products without an SPF are generally cosmetics, as long as their claims stay cosmetic. A therapeutic cream can be a listed medicine (AUST L) only if every ingredient is in the TGA's Permissible Ingredients Determination and every indication is a permitted indication: that is how we built a kava pain relief cream. The wider rules, including for products that are swallowed, are on medicine, food or cosmetic?

Sunscreens: primary or secondary

A primary sunscreen, presented mainly to protect the skin from UV, is a therapeutic good. It must be on the Australian Register of Therapeutic Goods before it is sold, generally as a listed medicine with an AUST L number on the label.
An SPF moisturiser stays a cosmetic only if all of these hold: SPF 4 to 15, a pack of 300 mL or 300 g or less, not presented as water resistant, no therapeutic claims other than about premature ageing from the sun, no ingredient from Schedule 2, 3, 4 or 8 of the Poisons Standard, an expiry date if it isn't stable for at least 36 months, and the secondary sunscreen, labelling and broad-spectrum requirements of AS/NZS 2604:2021 are met. Above SPF 15, it is a therapeutic sunscreen. Lip products and tinted foundations with SPF 4 or more are excluded under their own conditions.
Cosmetic sunscreens are still tested. They must meet the testing and labelling requirements of the Australian sunscreen standard.
Changes may be coming. The TGA consulted on improving sunscreen regulation from March to May 2026, including cosmetic sunscreens with high SPF claims. As of 19 October 2026 it had announced no outcome.

Selling cosmetics: registration and labels

Who registers. A business must register with AICIS if it imports ready-made cosmetics, unless they are for personal use, or imports essential oils, carrier oils, fragrance or base ingredients. Buying ingredients from Australian suppliers to blend doesn't need registration for that. Making a chemical for sale generally does, such as soap from fats or oils and lye, though soap made in Australia from no more than 10 kg of each fat or oil a registration year can be excluded. AICIS registers the business, not its products or ingredients.
When and what it costs. The registration year runs from 1 September to 31 August, and you register before you introduce a chemical in that year. The cost is a flat fee plus a levy based on the value of the chemicals introduced in the previous financial year: for 2026–27 it ranges from $85 (under $50,000 introduced) to $3,585 ($15 million or more), after a one-off levy discount; AICIS says levies return to their 2025–26 levels, indexed, from 2027–28.
What registration involves. Each chemical introduction is put into a category (listed, exempted, reported or assessed, among others), records are kept, and a declaration goes in at the end of each registration year.
The ingredient list. Labels follow the Consumer Goods (Cosmetics) Information Standard 2020, which the ACCC administers: every ingredient listed on the container, in descending order by volume or mass (or with ingredients under 1% and colour additives after the rest, in any order). It doesn't apply to therapeutic goods, free samples or testers.

What we build

Creams and serums on the cosmetics pathway or the TGA pathway, and the regulatory work that keeps a range compliant. From our records:

A kava pain relief cream, a TGA-listed medicine built to match the category's leading creams on formula and price, feel non-greasy, not stain, and come in a pack older users can open easily. We built the formula and R&D samples, the claims evidence, the TGA listing (updated after a preservative change), the stability program, the specification and the label, and we are managing manufacturing now, including the tube supply.
Vitable: a topical serum on the cosmetics pathway, matched to a TGA-listed capsule, with manufacturing of both managed through to delivery.
An international professional skincare brand, sold in more than 25 countries: formula and evidence work across two supplements and a sunscreen, with stability studies out to 36 months. Since 2024 we have run its regulatory work on a monthly retainer.
Deeply Rooted: an organic essential oil blend for children, made in New Zealand and sold in Australia, with the cross-border supply chain managed end to end.

Cosmetic manufacturing, managed

The same model as everything we make. We are not a cosmetic factory: we match the product to cGMP manufacturing partners by format, volume and margin, carry the specification, packaging and labelling, and manage release testing, imports and freight through to your warehouse or 3PL. See managed manufacturing.

Questions

: Yes. A kava pain relief cream we developed is a TGA-listed medicine: we built its claims evidence, secured the listing and updated it after a preservative change, and designed its stability program.
: Yes. For an international professional skincare brand we did the formula and evidence work on a sunscreen and two supplements, with stability studies out to 36 months.
: Yes. Vitable's hair range pairs a TGA-listed capsule with a serum on the cosmetics pathway, and we managed manufacturing for both.
: Yes. Since 2024 we have run an international skincare brand's Australian regulatory work on a monthly retainer, now in its third year.
: If your business imports cosmetics or cosmetic ingredients into Australia, or makes a chemical for sale, generally yes, for each registration year (1 September to 31 August) in which it does. AICIS registers the business, not each product. A business that buys all its ingredients from Australian suppliers to blend doesn't need to register for that. More in our AICIS registration guide.
: Only if it meets every condition in the Excluded Goods Determination: SPF 4 to 15, a pack of 300 mL or 300 g or less, not water resistant, no therapeutic claims beyond premature ageing from the sun, no Schedule 2, 3, 4 or 8 poisons, an expiry date if it isn't stable for at least 36 months, and the AS/NZS 2604:2021 requirements. If it misses any of them it is a therapeutic sunscreen, which generally must be on the ARTG.
: No. A product that is only a cosmetic isn't on the ARTG and has no TGA approval step. It must still meet consumer law, the ingredient labelling standard and, for the business, AICIS registration where that applies. If its claims or ingredients make it a therapeutic good, the TGA rules apply instead.
: Claims to treat acne will likely make it a therapeutic good. The Excluded Goods Determination keeps an acne product out of the medicines rules only if it is presented as controlling acne by cleansing, moisturising, exfoliating or drying the skin, with no Schedule 2, 3, 4 or 8 poisons. "Helps skin look clearer" is a cosmetic claim; "treats acne" is a therapeutic one.