The skin brightening creams Australia says are illegal to sell here

The TGA has issued a safety alert about a range of skin-brightening products sold under the CAROTONE name, saying they were found to contain an undeclared prescription-only medicine. In plain terms, a hydroquinone cream sold as a cosmetic.

Products of this kind are sold priced and packaged as cosmetics, with nothing on the tube to indicate that it contains a scheduled substance.

What the alert says, and what it does not

The pharmacovigilance journal Reactions Weekly indexed the alert under a heading naming undeclared hydroquinone, which is the substance at issue.

Hydroquinone is scheduled in Australia, and where it sits depends on strength. The Poisons Standard places it in Schedule 2, a pharmacy medicine, in preparations for external therapeutic or cosmetic use containing 2 per cent or less, with two carve-outs: hair preparations containing 0.3 per cent or less, and cosmetic nail preparations containing 0.02 per cent or less. Above 2 per cent it is Schedule 4, prescription only.

A hydroquinone cream sold over a counter that conceals the ingredient, and that has not been entered on the Australian Register of Therapeutic Goods, is an unapproved therapeutic good rather than a cosmetic that broke a rule.

This is not the first time the regulator has looked at this brand family. The TGA previously issued an alert on Caro White and Carotone products, stating that they had been supplied illegally as cosmetics while they had a higher than permitted level of hydroquinone. The products named then included Caro White Lightening Oil, Caro White Lightening Beauty Lotion, Caro White Lightening Beauty Cream, Carotone Lightening Body Lotion and Carotone Black Spot Corrector.

Two alerts about the same brand family. The findings differ in a way that matters: the earlier alert concerned hydroquinone above the level permitted in a cosmetic, while the 2026 alert, per its title, concerns an undeclared prescription-only medicine.

Why an undeclared hydroquinone cream matters more than a strong one

Scheduling is not bureaucracy for its own sake. Where a substance sits above a threshold, a prescriber decides the strength, decides how long it is used for, and watches what happens.

A person buying a hydroquinone cream off a shelf gets none of that. They do not know the concentration. And because the ingredient is undeclared, they do not know they are using a scheduled substance at all, so nothing about their skin’s response is connected in their mind to a medicine.

That is the harm in an undeclared active ingredient. It removes the information a person would need to notice that something is going wrong.

Where to take it instead

Underneath the marketing category of brightening sit conditions a doctor can name, and pigmentation that is bothering someone enough to buy a cream for it is a reason to see a GP rather than to try a different jar.

A GP can say what is actually going on, and can refer to a dermatologist where that is warranted. That route gives a person a diagnosis, a treatment chosen for it, and someone watching what happens. An unlabelled cream from a grocery aisle gives none of those things, and this article is not the place to set out treatment options, because that conversation belongs with a clinician who can see the skin in question.

How common is this, and who knows the risks

Australia has not published prevalence data on skin-lightening product use among Indian Australians, so anybody quoting a local figure is guessing. The closest usable evidence comes from the United States and should be read as indicative rather than as a measurement of this community.

A cross-sectional survey published in JMIR Dermatology on 2 November 2023 surveyed 175 South Asian American women and nonbinary individuals recruited through Facebook. It found that 31 per cent reported current or past use of skin-lightening products. Among those who had used them, 60 per cent reported adverse effects. Only 11 per cent said they had been aware of potential adverse effects beforehand. The authors note the sample is not representative of the South Asian American population generally.

That last number is the one that matters here. Roughly six in ten users experienced a problem, and roughly one in ten knew a problem was possible. The gap between those two figures is not caused by carelessness. It is caused by products that do not tell people what is in them, sold in places that carry no obligation to explain.

The test that tells you where you stand

An approved therapeutic good sold in Australia carries an AUST L or AUST R number on its label.

Victoria’s Department of Health applies that test in its advisory on Ayurvedic medicines, which covers products imported from overseas or purchased in Victoria, telling anyone taking such a product without an AUST L or AUST R number to stop taking it immediately. That advisory is about ingested medicines contaminated with heavy metals rather than about creams, so it is not a direct read-across, but the label test itself is the same one. A therapeutic good needs an AUST number.

Ingredients in cosmetic products are regulated separately, as industrial chemicals under the scheme administered by AICIS, and a cosmetic lawfully carries no AUST number at all, which is precisely why a hydroquinone cream that is secretly a medicine can sit on a shelf looking like a cosmetic.

Check the shelf at home before checking the shelf at the shop.

The thing this article is not going to do

It is not going to lecture anyone about why they bought the cream.

Colourism is not an individual failing. It is an inheritance, carried in family remarks about a newborn’s complexion, in matrimonial advertisements, in decades of advertising that sold lightness as opportunity. A person reaching for a brightening cream is usually responding to something that was taught to them, and the useful response is information rather than judgement.

What is worth saying is narrow and factual. A tube that conceals a prescription medicine takes away your ability to make a decision about your own body. Whatever anybody thinks about the beauty standard behind the purchase, that part is not a matter of opinion.

The regulator has named this brand family twice. If a hydroquinone cream from this brand family is in your bathroom, the question for a pharmacist or GP is simple enough to ask, and the answer costs nothing.