Cosmetics and therapeutics

Overview

Products are determined to be either ‘cosmetics’ or ‘therapeutic goods’ based on three factors:

• the primary use of the product
• the ingredients in the product
• the claims made about the product

We regulate chemicals that are imported or manufactured for an 'industrial' use – including the ingredients in cosmetics.

The Therapeutic Goods Administration (TGA) regulates medicines and products that are marketed as having a ‘therapeutic’ effect – including most skin-whitening lotions, primary sunscreens, disinfectants, complementary medicines and blood products.

What is a cosmetic?

A cosmetic product is a substance designed to be used on any external part of the body – or inside the mouth – to change its odour or appearance, cleanse it, keep it in good condition or protect it.

It’s important to note we don't set or enforce labelling requirements for cosmetics in Australia and don’t provide specific advice about this. For more help on this topic, see labelling, SDS and packaging.

Examples of cosmetics

Face and nail

• Lipstick and lip balms with SPF sunscreen that comply with the Therapeutic Goods (Excluded Goods) Determination, 2018
• Nail care products including nail hardeners and products to deter nail biting
• Make-up such as mascara, eyeshadow, primer and bronzer
• Nail polish and varnish
• Tinted bases and foundation without SPF sunscreen, including liquids, pastes and powders
• Make-up removers
• Lipstick and lip balms without SPF sunscreen
• Face masks and scrubs

Hair care and hairdressing products

• Anti-dandruff hair care products that comply with the Therapeutic Goods (Excluded Goods) Determination, 2018
• Hair tints, hair dyes and bleaches
• Products for waving, straightening and fixing hair
• Hair-setting products such as gels, sprays and lotions
• Shampoo and hair-cleansing products, including lotions and powders
• Hair conditioner
• Hairdressing products such as lotions, lacquers and brilliantines

Oral and dental hygiene

• Toothpaste and gel
• Denture cleansers and adhesives
• Some dental bleaches and whiteners

Desensitising toothpastes and gels are not cosmetics. They are therapeutics and are regulated by the TGA.

Perfumes

• Perfumes and colognes
• Eau de toilette
• Eau de colognes
• Eau de parfum

Personal hygiene

• Feminine hygiene products such as intimate cleaners, deodorants, wash, powder, moisturisers and gels. We do not regulate pads, tampons and panty liners because they are classified as articles.
• Deodorants
• Cleansers, including soap, deodorant, astringent and skin washes
• Shaving products, such as creams, foams and lotions
• Bath and shower preparations, such as salts, foams, oils and gels
• Depilatories
• After-bath powders
• Hygienic powders

Skin care

• Secondary sunscreen products that comply with the Therapeutic Goods (Excluded Goods) Determination, 2018
• Anti-acne skin care products that comply with the Therapeutic Goods (Excluded Goods) Determination, 2018
• Skin moisturisers without SPF sunscreen such as creams, lotions, gels and foams
• Sunbathing products without SPF sunscreen or with SPF sunscreen
• Emollients such as creams, emulsions, lotions, gels and oils for the skin
• Products for tanning without sun (without SPF sunscreen)
• Some skin-whitening products (without SPF sunscreen)
• Anti-wrinkle products (without SPF sunscreen)
• Anti-ageing products (without SPF sunscreen)

What is a therapeutic?

A therapeutic product is used to prevent, diagnose or treat a disease or its symptoms, or affect the structure or functions of the human body.

If your product is for therapeutic use, read the TGA's regulation basics for more information.

Examples of therapeutics

• Primary sunscreens (products that are primarily used for protection from UV radiation) are regulated as therapeutics
• Moisturisers that contain a sun-screening agent as a secondary component and have a stated therapeutic purpose ('helps protect skin from the damaging effects of UV radiation') are regulated as medicines
• Skin-whitening lotions that inhibit the physiological process of melanin production are regulated as medicines. For example, products that contain the chemical hydroquinone
• Tablets can have side effects or interact in unwanted ways with other prescriptions, and are regulated as medicines.

Which chemicals are allowed in cosmetics?

We're often asked which chemicals are 'allowed' in cosmetics. However, in Australia there is no single list of chemicals that are banned or restricted in products. The best place to start is the Standard for the Uniform Scheduling of Medicines and Poisons – also known as the Poisons Standard. This is a record of decisions about the classification of medicines and chemicals used in consumer products. It may be helpful to refer to this resource when determining if you can market your product as a cosmetic.

You can also refer to our page on banned or restricted chemicals for more information on the regulation of chemicals in Australia.

What about cosmetic injectables?

Cosmetic injections are medical procedures that involve injecting a substance under your skin to change an aspect of your appearance. These products include:

• Botox and similar neurotoxins designed to temporarily relax facial muscles
• dermal fillers

We do not regulate the chemicals in cosmetic injectables – the TGA regulates these products.

Note: The chemicals used in tattoo and permanent make-up inks are classified as industrial chemicals in Australia. Learn more about tattoo and permanent make-up (PMU) inks.

Still not sure?

Our decision tool can help you determine whether your product is a cosmetic or therapeutic good or contact us to ask a question.