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Review of listed sunscreen products

30 July 2018

We completed a desktop review of selected listed sunscreen products to determine whether these products met appropriate quality, safety and efficacy standards.

No deficiencies in regulatory requirements were identified that raise concerns relating to harm or lack of effectiveness of sunscreens when used by consumers. However, our findings serve to highlight some key reminders for consumers, with particular emphasis on the correct application of sunscreen.

See the Information for consumers from TGA's compliance review of sunscreens announcement or the Findings from TGA's compliance reviews of sunscreens page for further details on the outcomes of this review.

Background

Most therapeutic sunscreens marketed in Australia are currently included in the Australian Register of Therapeutic Goods (ARTG) as listed medicines. All listed medicines, including sunscreens, are subject to compliance reviews at any time while they remain on the ARTG. This allows us to ensure that the products meet all of their regulatory requirements for labelling, efficacy, safety and quality. This review was initiated as part of our usual monitoring and review process, not in response to concerns regarding the quality, safety or efficacy of listed sunscreens.

What did the TGA do?

We requested information from sponsors for 174 sunscreens, representing approximately 20% of sunscreens listed on the ARTG. We selected the sunscreens either randomly or based on regulatory intelligence, such as complaints from members of the public or our analysis of products likely to be affected by changes to regulatory requirements.

80 (46%) sunscreens did not progress to review:

  • 70 (40% of total) were cancelled from the ARTG at the request of the sponsor after receiving our request for information. Sponsors cited the following reasons:
    • the sunscreen was no longer being manufactured; or
    • the sunscreen would no longer be supplied due to commercial decisions.
  • 6 (3% of total) had not yet been manufactured.
  • 4 (2% of total) were cancelled by us due to non-payment of annual charges

94 (54%) progressed to review. We assessed:

  • The labels and presentation of the sunscreens.
  • The manufacturing information, such as the full formulation of the sunscreen, the finished product specifications and certificate of analysis for the last released batch of the
  • The evidence held to support all indications and/or claims, including data to support the SPF, broad spectrum and water resistance claims.

After completing each the assessment, we sent each sponsor a letter detailing any compliance deficiencies identified in the assessment. Sponsors were given 4 weeks to rectify the deficiencies or remove the product from the ARTG.

After receiving the sponsor's response, we established the final compliance status of the sunscreen, and whether any further regulatory actions were required. In the event that a sponsor was unable to satisfactorily address all non-compliance issues, we cancelled the sunscreen from the ARTG.

More information regarding the regulation of sunscreens and the relevant legislation and standards can be found in the Australian Regulatory Guidelines for Sunscreens.

Findings

Based on the findings of our review, we hold no concerns that sunscreens on the Australian market are of poor quality, are causing harm to consumers or are ineffective. We encourage consumers to continue using sunscreens for protection against the harmful effects of UV radiation.

Quantitative findings

No deficiencies in meeting regulatory requirements were identified by us in 34% (32/94) of the sunscreens reviewed.

We identified deficiencies for the remaining 66% (62/94) of sunscreens. We consider these deficiencies are unlikely to cause harm to consumers or to significantly impact the effectiveness of the sunscreens in everyday use. This is because:

  • The combination of all regulatory requirements provide a high degree of confidence in the quality, safety and efficacy of sunscreens—although all requirements support the safe and effective use of sunscreens, they do so to different extents;
  • There is widespread general understanding in the community about the purpose and appropriate use of sunscreens (e.g. that sunscreens should be regularly reapplied);
  • The extent of the deficiency for any individual requirement was minor and/or not anticipated to significantly impact on the every-day use of the product for the vast majority of consumers.

None of the deficiencies we identified warranted recalling a product already on the market.

These issues ranged from those able to be addressed by sponsors to keep their product listed on the ARTG, such as by updating the product labels or updating the ARTG record, to issues that prevented the product from remaining on the ARTG.

We ensured appropriate actions were taken for all sunscreens with deficiencies. The outcomes of these actions are described below:

  • 32 (34% of reviewed products) remained on the ARTG after the sponsor made changes to the labels, advertising or ARTG record. The deficiencies mostly related to specific requirements for labelling (e.g. directions for use) and advertising (e.g. claims about the duration of water resistance). Although these requirements support the safe and effective use of sunscreens, the deficiencies found were unlikely to have a major impact on consumers..
  • 24 (26% of reviewed products) were cancelled from the ARTG by the sponsor after we notified them of the deficiencies. Notable deficiencies included:
    • Presence of ingredients MI and/or MCI above the tighter quantity restriction that was imposed from 1 October 2017 (18 products - 19% of total reviewed; these products were previously compliant with requirements)
    • Presence of a commonly-used sunscreen preservative at a concentration exceeding that permitted for use (1 product)
    • Broad spectrum testing results met most, but not all, of the stringent requirements specified in the Standard (1 product).
    • SPF testing results supported a lower SPF value than claimed on the label (1 product).
    • SPF or broad spectrum testing documentation, that was provided to us to determine whether the product met SPF or broad spectrum claims, was incomplete for 9 products (9.6% of total reviewed). Sponsors may have been able to provide further documentation, but instead chose to cancel their good from the ARTG (most (8) contained MI and/or MCI above the quantity permitted from 1 October 2017).
  • 6 (9.7% of reviewed products) were cancelled from the ARTG by the TGA because either:
    • The level of MI and/or MCI was above the new quantity restriction imposed on 1 October 2017, preventing the product from remaining on the ARTG (4 products).
    • The sponsor did not respond to our request for information (2 products).

Qualitative findings

We frequently observed that adequate instructions for use were not present on aerosol sunscreens. Although all sunscreens are required to include directions for use in accordance with the Australian and New Zealand Sunscreen Standard requirements (AS/NZS 2604:2012), at this stage there are no specific legislated requirements for the effective use of aerosol products because they are a relatively new addition to the market. As a member of the relevant Standards Australia technical committee, the TGA will participate in future revisions to the Standard and consideration of provisions in relation to aerosols.

It is the sponsor's responsibility to inform consumers that aerosol sunscreens are only effective if applied liberally and thoroughly, preferably in a similar manner to applying a lotion.

Information for sponsors

The TGA periodically reviews the regulatory requirements for medicines to ensure the appropriate level of safety, quality and/or efficacy. Sponsors are reminded to regularly monitor the TGA website for any legislative or regulatory updates that may be relevant to their products.

Updates to the Poisons Standard

Approximately 50% of sunscreens reviewed were selected because they contained methylisothiazolinone (MI) and methylchloroisothiazolinone (MCI) excipient ingredients used as antimicrobial preservatives. On 1 October 2017, the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) - the Poisons Standard - was updated to impose tighter restrictions on the quantity of these ingredients to align with a change to the regulation of these substances in the European Union. These restrictions provide a greater safety margin for consumers using products for topical use, as these ingredients have the potential to cause skin sensitisation (allergic-type reactions) in some individuals.

Many of the sunscreens we reviewed contained MI and MCI at concentrations that were non-compliant with the tighter scheduling restrictions introduced from 1 October 2017. Consequently, these products were unable to remain listed on the ARTG once ingredients in them became scheduled and were cancelled from the ARTG during the course of our review.

We remind all sponsors of sunscreens to keep up to date with amendments to the Poisons Standards at all times to ensure their product meets regulatory requirements.

Transition to the 2012 Sunscreens Standard

When the Australian and New Zealand Sunscreen Standard AS/NZS 2604:2012 (the Standard) came into effect in 2012, sunscreen products listed prior to 2012 could continue to comply with the 1998 Standard (AS/NZS 2604:1998) for a period as long as they did not make any major changes to their product. This was a phase-out arrangement to avoid major disruption of the supply of sunscreens in Australia. The main differences between the two editions of the Standard is that the current edition allows SPF ratings higher than SPF30+, with related labelling adjustments.

All sunscreens listed from 10 November 2012 must adhere to the 2012 edition of the Standard. Several of the sunscreens we reviewed were required to comply with the 2012 Standard, based on the date of listing on the ARTG, but were intended by the sponsor to comply with the 1998 Standard. These were therefore deficient in meeting regulatory requirements.

Sponsors seeking to change the SPF rating of a product listed prior to the implementation of the 2012 Standard must relist the product on the ARTG with a new AUST L number.

Please note, only indications drawn from a Permitted Indications list are now required to be used for all new listings on the ARTG. The Permitted Indications list includes indications prescribed by the 2012 AS/NZS Sunscreens Standard. All listed medicines, including sunscreens, are required to transition to Permitted Indications by 6 March 2021.