Australia has one of the highest rates of skin cancer worldwide, making sun protection a vital part of the daily life of Australians. The application of sunscreen, which functions by absorbing or reflecting harmful ultraviolet (UV) radiation, is a crucial aspect of sun protection practices. Therefore, sunscreen is subject to strict regulations. Its production and sale must comply with all relevant regulations and standards to ensure the health and safety of consumers.
Part 1 Regulatory Framework and Competent Authority
1.1 Existing Main Regulations for Sunscreens
Classification | Regulations | Function | Effective Date | Status | |
Cosmetic sunscreen | Industrial Chemical Act 2019 | It serves as overarching regulatory framework for the importation and manufacture (i.e., introduction) of industrial chemicals in Australia, including cosmetic sunscreens. It establishes the Australian Industrial Chemicals Introduction Scheme (AICIS) to regulate the introduction of industrial chemicals into the Australian market. | 2024/7/1 | In force | |
Consumer Goods (Cosmetics) Information Standard 2020 | It outlines the mandatory requirements for cosmetic ingredient labeling. Sunscreen classified as cosmetic screens shall comply with this regulation. | 2020/11/24 | In force | ||
Poisons Standard | Also known as the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), it includes substances applicable in sunscreen products as well as the related packaging and labeling requirements. | 2024/5/30 | In force | ||
Therapeutic sunscreen | Overarching | Therapeutic Goods Act 1989 | It serves as overarching regulation for therapeutic goods (including therapeutic sunscreens) in Australia. The competent authority is the Therapeutic Goods Administration (TGA), which is responsible for enforcing the standards and requirements set in the Act 1989 to protect public health. | 2024/7/1 | In force |
Therapeutic Goods Regulations 1990 | It serves as the enforcement rules of the Therapeutic Goods Act 1989 | 2024/7/1 | In force | ||
Therapeutic Goods (Excluded Goods) Determination 2018 | The regulation excludes secondary sunscreens from the scope of the Therapeutic Goods Act 1989 | 2024/7/1 | In force | ||
Sunscreen guideline/standard | The Australian Regulatory Guidelines for Sunscreens, ARGS | ARGS describes the regulatory requirements and standards for sunscreens regulated as therapeutic goods in Australia by the TGA under the Therapeutic Goods Act 1989. | 2023/05 | In force | |
Australian/New Zealand Sunscreen Standard AS/NZS 2604:2021 | It details the procedures for performance testing and labeling requirements for sunscreen products marketed in Australia. From July 1, 2024, all new sunscreen products included in the ARTG must comply with the Australia Sunscreen Standard 2021. | 2024/4/11 | In force | ||
Therapeutic sunscreen ingredient | Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2024 | This instrument includes all ingredients that are available for use in listed therapeutic sunscreens and the requirements for their use. | 2024/6/6 | In force | |
Therapeutic sunscreen labeling/claiming | Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines | It serves as the standard for the labeling of non-prescription medicines (including therapeutic sunscreen) | 2023/4/30 | In force | |
Therapeutic Goods (Permissible Indications) Determination (No. 1) 2021 | It specifies the indications that are permitted for listed therapeutic sunscreens included in the ARTG under the Therapeutic Goods Act 1989. | 2021/1/20 | In force | ||
Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 | It includes requirements for the advertising of therapeutic goods (including therapeutic sunscreen). | 2021/12/1 | In force | ||
GMP requirements | PIC/S Guide to GMP for medicinal products, PE009-16 | Therapeutic sunscreens shall be manufactured adhering to this Guide adopted by Australia. | 2024/6/3 | In force | |
/ | Australian Register of Therapeutic Goods, ARTG | A public database of therapeutic goods (including therapeutic sunscreens) supplied in Australia | / | In force |
1.2 Competent Authority
In Australia, there are three main competent authorities responsible for regulating sunscreens:
Australian Industrial Chemicals Introduction Scheme (AICIS): Established by the Industrial Chemicals Act 2019, AICIS serves as the overarching regulator of introduction (i.e., importation and manufacturing) of industrial chemicals in Australia, including cosmetic sunscreens. It is important to note that AICIS does not regulate therapeutic goods and is not involved in setting or enforcing labeling and advertising requirements for cosmetics.
The Therapeutic Goods Administration (TGA): Operating under the Australian Government Department of Health, TGA is responsible for regulating therapeutic goods, including therapeutic sunscreens, including their manufacturing, labeling, and advertising.
Australian Competition and Consumer Commission (ACCC): It is responsible for regulating cosmetic labeling and advertising standards to ensure product safety.
Part 2 Definition and Classification of Sunscreen Products
2.1 Definition
Sunscreen products refer to products containing any component able to absorb, reflect, or scatter Ultraviolet (UV) rays, which are intended to be used on the surface of human skin to protect against erythema and other UV-induced damages. Based on the overall purpose of the product, sunscreen products shall be classified as either primary sunscreen or secondary sunscreen.
Primary sunscreen refers to a sunscreen product whose primary function is sun protection.
Secondary sunscreen refers to a product that is represented as having a primary function other than sun protection while providing some protection of the skin from UV radiation. For instance, a cream that includes sun-screening agents but primarily aims to moisturize the skin is a secondary sunscreen.
2.2 Classification
Sunscreens in Australia can be classified as cosmetic sunscreens or therapeutic sunscreens based on a comprehensive assessment of their intended use and claims. Primary sunscreens and part of secondary sunscreens are classified as therapeutic goods under the regulation of TGA. Most secondary sunscreens are classed as cosmetics if they meet the definition of cosmetics and comply with all the relevant requirements of the Therapeutic Goods (Excluded Goods) Determination 2018. They are excluded from therapeutic goods legislation and regulated under the AICIS.
Cosmetic Sunscreen | Therapeutic Sunscreen | |
Regulatory authority | AICIS | TGA |
Product description | Cosmetic sunscreen products shall: • not be therapeutic goods and are excluded from therapeutic goods legislation. • not contain any substances included in Schedules 2, 3, 4, or 8 of the Poison Standard. Cosmetic sunscreen products include: • products applied to the lips with an SPF of 4 or more. • tinted bases and foundations (liquids, pastes, or powders) with an SPF of 4 or more. • moisturizing skin care products for dermal application (including anti-wrinkle, anti-aging, and skin whitening products), in a pack size no larger than 300mL or 300g, with an SPF between 4 and 15. • sunbathing skin care products (oils, creams, gels and after-sun care products excluding sun tanning products) in a pack size not larger than 300mL or 300g, with an SPF between 4 and 15. | Therapeutic sunscreen includes: • Primary sunscreens carrying SPF claims of 4 or more • Some secondary sunscreens (i.e. those secondary sunscreens that are not excluded from therapeutic goods regulation as per the Excluded Goods Determination) such as sunbathing and moisturizing skin care products with an SPF of over 15. • Sunscreens with an SPF of 4 or more that contains an insect repellent. • Sunscreens with specific ingredients listed in Schedule 5—Therapeutic goods exempt from the operation of Parts 3-2 and 3-2A of the Act of the Therapeutic Goods Regulations 1990. |
Part 3 Requirements for Sunscreens Supplied in Australia
3.1 Requirements for Cosmetic Sunscreens Supplied in Australia
When introducing sunscreens classified as cosmetic sunscreens in Australia, enterprises shall register their business with AICIS and categorize all chemical ingredients in their sunscreen product before introducing them into Australia. The introduction stages are briefly summarized below. For more detailed procedures, please refer to the Australian Cosmetic Regulation.
3.1.1 Business Registration
Sunscreen manufacturers and importers shall register their business on the AICIS business service platform before importing and manufacturing their products in Australia within any given registration year, spanning from September 1 to August 31 of the next year. The registration process involves completing an online form and paying the registration fee.
3.1.2 Categorization of Industrial Chemicals Used in Sunscreens
Under the AICIS scheme, all industrial chemicals shall undergo the categorization process before they can be imported and manufactured. Sunscreens enterprises shall review the industrial chemicals in their products and categorize each chemical into one of the five introduction categories based on the seven-step guide given by the AICIS.
Introduction Category | Application scope |
Listed introduction | Chemicals listed on the Australian Inventory of Industrial Chemicals (AIIC) |
Exempted introduction | Chemical with very low risk |
Reported introduction | Chemicals with low risk |
Assessed introduction | Chemicals with medium to high risk |
Commercial evaluation | Time-limited authorizations granted to help an introducer determine a chemical’s commercial potential |
3.1.3 Reporting
After determining the type of chemicals to be introduced, the enterprises can move forward to the reporting stage. The specific reporting requirements vary based on the category of the chemical.
Introduction Category | Reporting Requirement |
Listed introduction | / |
Exempted introduction | Submit a once-off post-introduction declaration (PID) after the introduction |
Reported introduction | Submit a once-off pre-introduction report (PIR) before the introduction |
Assessed introduction | Apply and obtain an assessment certificate before the introduction |
Commercial evaluation | Apply for a commercial evaluation authorization before the introduction |
3.1.4 Record Keeping
Enterprises are obligated to keep records of the industrial chemicals they have imported or manufactured. The amount and type of records subject to record-keeping vary depending on the introduction category. Notably, these records shall be kept for 5 years and shall be provided within 20 working days if requested by AICIS.
3.1.5 Annual Declaration
Registered cosmetic sunscreen importers and manufacturers shall submit an annual declaration at the end of each registration year to confirm that all the industrial chemicals imported and manufactured during the previous registration year comply with related laws and regulations. The annual declaration is due by November 30 each year. Failure to conduct annual declarations may result in penalties.
3.2 Requirements for Therapeutic Sunscreens Supplied in Australia
Supplying therapeutic sunscreens needs a sponsor, which refers to any individual or company wishing to import and/or manufacture therapeutic goods in the Australian market. Unless a specific exemption or approval, sponsors must apply for market authorization with the TGA before supplying therapeutic sunscreens. In most cases, this involves the entry of their sunscreens (listed or registered) in the Australian Register of Therapeutic Goods (ARTG). Sunscreens included in the ARTG will be given an AUST identification number that must be displayed on the label and packaging.
3.2.1 Ensure compliance with all legal requirements
Sponsors shall ensure that their sunscreen products are therapeutic screens under the regulation of TGA. It is also the sponsor’s responsibility to ensure their product meets all relevant legal requirements, including:
For therapeutic sunscreens that are listed medicines, the product shall only include pre-approved ingredients listed in Permissible Ingredients Determination and pre-approved indications listed in Permissible Indications Determination.
The product shall meet manufacturing quality standards. All sunscreen products released on the Australian market must be manufactured according to the Good Manufacture Practice (GMP) principles of PIC/S guide to GMP, PE0009-16.
The product shall meet the testing and labeling requirements provided in the AS/NZS 2604:2021.
The product shall meet all other therapeutic good legislative requirements, such as labeling and advertising requirements
3.2.2 ARTG
Australian Register of Therapeutic Goods (ARTG), a database of therapeutic goods supplied in Australia, provides information such as the product name, sponsors, permitted indications, and components. Sponsors should submit their applications through the TGA Business Services (TBS) before their sunscreens can be legally supplied in Australia. Specific ARTG requirements for therapeutic sunscreens are summarized in the following table.
Sunscreen Category | Product Description | ARTG Requirement |
Listed therapeutic sunscreens | Most therapeutic sunscreen products fall under the listed (lower risk) medicines framework and shall be included in the ARTG with an “AUST L” identification number. Therapeutic sunscreens can be listed in the ARTG if they: • only include low-risk ingredients permitted in Permissible Ingredients Determination. • only have therapeutic indications permitted in Permissible Indications Determination. Listed sunscreens are not required to be pre-market evaluated by the TGA at the time of listing. Instead, they are included in the ARTG based on sponsor certifications that their therapeutic good meets all legislative requirements. The supporting data may be requested by the TGA at any time after the medicine is included in the ARTG. This could include information such as copies of labeling, SPF testing results, broad-spectrum performance, water resistance, or stability. Sponsors are expected to provide this information within a reasonable time when requested. For detailed listing procedures, please refer to the Application and submission user guide: Listed and assessed listed medicines | Required to be listed in ARTG |
Registered therapeutic sunscreens | If sunscreen includes ingredients or indications that are not on the pre-approved list for listed medicines. It is classified as registered therapeutic sunscreen and shall undergo a full TGA pre-market assessment of its safety, quality, and efficacy. Detailed procedures can be found in the Australian Regulatory Guidelines for OTC Medicines (ARGOM). | Required to be registered in ARTG |
Exempt sunscreen | A sunscreen product regulated under the Therapeutic Goods Act 1989 but not required to be registered or listed in the ARTG is an exempt sunscreen. A sunscreen is exempt from the ARTG if: • the SPF established according to the AS/NZS 2604:2021 is less than 4 • the label claims to comply with the AS/NZS 2604:2021 • the product does not indicate the treatment of a serious disease, condition, ailment, or defect as specified in the Advertising Code • the product does not contain ingredients listed in Item 8 of Schedule 5 of the Therapeutic Goods Regulations 1990, such as ingredients from humans, or organs from cows, sheep, goats, or mule deer (if the sunscreen contains one of these ingredients, it is not exempt from the ARTG). | Exempted from the ARTG |
3.2.3 On-going Responsibility
Sponsors shoulder ongoing responsibilities and legal obligations after the sunscreen product is included in the ARTG. Any issues relating to their product shall be reported to TGA to ensure the sunscreens continue to meet regulatory requirements. Civil and criminal penalties may apply where these requirements are not met. The ongoing responsibilities include:
Obtaining information from the manufacturer when requested by the TGA
Providing information to the TGA on request and within required legislative timeframes
Ensuring all manufacturers hold a relevant manufacturing license, clearance, certification, or conformity assessment certificate, as required
Notifying the TGA of adverse events or problems with the goods
Meeting the advertising requirements for therapeutic goods.
Part 4 Sunscreen Ingredients
4.1 Cosmetic Sunscreen Ingredients
Australia does not provide a list of banned or restricted ingredients specifically for cosmetic screens at the national level. The bans and restrictions on chemicals and consumer product ingredients, including those used in cosmetics, are regulated by individual state and territory authorities. When determining the marketability of a product as a cosmetic, enterprises should refer to the Poison Standards, a valuable reference regarding the classification of chemicals in consumer products. The standard covers details such as chemical names, bans, and restrictions, maximum concentrations, container specifications, label requirements, etc.
4.2 Therapeutic Sunscreen Ingredients
Listed therapeutic sunscreens may only contain low-risk ingredients selected from the Permissible Ingredients Determination. Sunscreen sponsors should seek this regulation for restrictions when applying each ingredient in their product. Besides, the Australian Approved Name (AAN) for each active ingredient must be included on the product label.
4.2.1 Active Ingredients
Active ingredients are included in therapeutic sunscreens at significant concentrations to protect the skin from ultraviolet UV radiation and may be expected to interact with human tissues and physiological systems topically (skin, eyes, and mucosal surfaces) and systemically (if they penetrate the skin and move into the systemic circulation).
Active ingredients restricted for use in therapeutic sunscreens are specified in the Permissible Ingredients Determination. They can also be found in the TGA ingredient database, an electronic repository of approved ingredient names of therapeutic substances, by searching their AAN (Australian Approved Name), or CAS numbers.
4.2.2 Excipient Ingredients
An excipient ingredient in a sunscreen means an ingredient other than the active ingredients. Excipient ingredients may serve as fragrance, preservative, or solvent. Although therapeutic claims cannot be made for excipient ingredients, they can still impact human health and safety. Sponsors therefore should evaluate how these ingredients affect skin sensitivity to sunlight and ensure overall product safety.
If an excipient has a known active function, evidence supporting its role and purpose as an excipient will be required. The concentration of excipients with known active functions in the formulation must remain below the level of playing an active role in the product. If its concentration exceeds the threshold for active function, it should be classified as an active substance rather than an excipient, and a justification for its use must be supplied.
In addition, if an ingredient’s concentration is above the approved safety limit for listed products, the product must be registered with the ARTG.
4.2.3 Nanoparticle Ingredients
A nanoparticle ranges from 1 to 100 nanometres in size and is invisible to the human eye. Ingredients may be used in nanoparticle form in therapeutic sunscreens. For instance, nanoparticulate titanium dioxide and zinc oxide are commonly used in sunscreens. Other ingredients may be used in nanoparticle form if specifically evaluated and approved by the TGA. The particle size of the active ingredients is not required to be declared on sunscreen labels.
Part 5 Sunscreen Labeling Requirements
In Australia, labeling regulations are established for both cosmetic and therapeutic sunscreen products. It is crucial for enterprises to thoroughly understand and adhere to labeling requirements for compliance.
Cosmetic Sunscreen | Therapeutic Sunscreen |
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5.1 Cosmetic Sunscreen Labeling Requirements
Sunscreen, classified as a cosmetic product, whether imported or manufactured in Australia, shall be in line with the mandatory labeling requirements outlined in the Consumer Goods (Cosmetics) Information Standard 2020.
The following provides some key information on the labeling requirements from this mandatory standard.
Product ingredient information should be available to consumers at the point of sale.
The listing of product ingredients is required on the container or on the product itself, if not packed in a container.
Where the container or the product is with a size, shape, or nature that prevents ingredient labeling by any of the above methods, the mandatory standard requires the display of information to allow consumers to be informed.
The labeling of ingredients on cosmetics such as make-up, deodorant, or moisturizer usually appears on the packaging or outer casing of the product for consumer knowledge.
When listing ingredients, the ingredients need to appear in descending order calculated by either mass or volume.
Alternatively, the mandatory standard allows for the listing of ingredients in the following way:
i. ingredients (except color additives) in concentrations of 1 % or more in descending order by volume or mass
ii. followed by ingredients (except for color additives) in concentrations of less than 1% in any order
iii. followed by color additives in any order
The mandatory standard does not require the listing of the quantity or percentage of each ingredient.
5.2 Therapeutic Sunscreen Labeling Requirements
Sunscreen labels are required to comply with all labeling requirements for therapeutic goods as well as labeling requirements of the Sun Standard AS/NZS 2604:2021 adopted by the TGA. Generally, sunscreen labels should provide the following information:
If the product is on the ARTG (the AUST number)
The Sun Protection Factor (SPF)
The level of sunscreen protection
The UV protection e.g. broad spectrum
Active ingredients
Instruction for use: how much to use and how often to reapply
Advice to avoid excessive exposure to the sun, and to seek shade, use protective clothing, hats, and sunglasses.
Any advisory or warning statements relating to ingredients
Storage conditions
Expiry date
Three Noteworthy Labeling Requirements
In Australia, all therapeutic sunscreens, regardless of type, need to meet three label requirements, namely sun protection factor (SPF), broad spectrum, and water resistance.
SPF
The SPF indicates how effective the sunscreen is against sunburn. The numerical SPF value can provide the user with a direct measure of the sunscreen efficacy, helping them select an appropriate product based on their skin sensitivity and exposure to the sun. The higher the number, the stronger the protection.
SPF | SPF Claim on Label | Description/Level of Protection |
1-3 | Not allowed to be claimed | Not allowed to be claimed |
4-14 | 4,6,8,10 | Low protection |
15-29 | 15,20,25 | Medium or moderate protection |
30-59 | 30,40,50 | High protection |
60 or higher | 50+ | Very high protection |
Broad Spectrum
The “broad spectrum” label implies that the sunscreen protects the skin from UVB and UVA radiation. UVA is the radiation that is believed to be the main cause of long-term damage. Sunscreens that are not broad spectrum can only protect against UVB radiation. Therefore, sunscreens with a “broad spectrum” label offer higher protection.
SPF | SPF Claim on Label | Broad Spectrum | ||
Primary | Secondary | |||
Skincare | Color/Lip | |||
1-3 | Not allowed to be claimed | Not allowed to be claimed | Not allowed to be claimed | Not allowed to be claimed |
4-14 | 4,6,8,10 | Compulsory | Compulsory | Optional |
15-29 | 15,20,25 | Compulsory | Compulsory | Optional |
30-59 | 30,40,50 | Compulsory | Compulsory | Compulsory |
60 or higher | 50+ | Compulsory | Compulsory | Compulsory |
Sunscreen with Water-resistance
The “water resistant” label indicates that the sunscreen remains effective in water (i.e., during swimming or after sweating) for a certain time. In Australia, the maximum water-resistant duration that can be claimed on the label is 4 hours.
Tested SPF after immersion | Maximum water resistance time claimable |
At least 4 but less than 8 | No claim |
At least 8 but less than 15 | 40 min |
At least 15 but less than 30 | 2h |
At least 30 SPF or above | 4h |
Part 6 Sunscreen Claims
6.1 Cosmetic Sunscreen Claims
Cosmetic sunscreens are primarily designed for cosmetic or skincare use and are limited to only having cosmetic claims. However, cosmetic sunscreen products do not serve the purpose of treating or preventing skin conditions or diseases. As such, manufacturers and marketers must ensure that these products do not have any therapeutic claims or implications that they can heal, cure, or mitigate any medical issues related to the skin.
6.2 Therapeutic Sunscreen
6.2.1 Therapeutic Claims
Therapeutic claims shall be made for therapeutic sunscreen relating to sunburn and skin cancer. According to Table 12—Indications relating to skin of the Therapeutic Goods (Permissible Indications) Determination (No. 1) 2021, some higher-level indications are permitted for sunscreens, these include:
A broad-spectrum sunscreen with an SPF of 30 or higher is permitted to carry the following indications:
i. May assist in preventing some skin cancers.
ii. May reduce the risk of some skin cancers.
iii. Can aid in the prevention of solar keratoses.
iv. Can aid in the prevention of sunspots.
A broad-spectrum sunscreen with an SPF of 4 or higher is permitted to carry the indication that it can aid in the prevention of premature skin aging.
6.2.2 Non-therapeutic Claims
Therapeutic sunscreens may also carry some non-therapeutic claims. The sponsor must be able to substantiate these claims with truthful and non-misleading certifications. If the certification by the sponsor is incorrect, the TGA can cancel the listing of the product from the ARTG. Examples of these non-therapeutic claims are as below:
Cosmetic claims, such as “moisturizing”
Insect repellent claims
Content claims, such as “contains Vitamin E”, “contains 30% more”.