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Findings from TGA’s compliance review of sunscreens

30 July 2018

We recently undertook a desktop review of listed sunscreen products to provide a snapshot of the quality, safety and efficacy of sunscreens currently on the Australian market. TGA staff examined labels and other data provided by the sponsors, including manufacturing and product formulation documents, and sun protection factor (SPF) test results. This review allowed us to assess whether these sunscreens met relevant regulatory requirements under the Therapeutic Goods Act 1989, including those set out in the Australian and New Zealand Sunscreen Standard AS/NZS 2604:2012 (the Standard).

We found no compliance deficiencies that concern us in relation to quality, safety or efficacy of sunscreens in everyday use. This result confirms that consumers can have confidence in the sunscreen products currently available on the Australian market when used as directed on product labels.

However, the review has highlighted a number of key messages for consumers. These include that side effects, such as allergic reactions, are possible when using any skin product, including therapeutic sunscreens. In addition, the effectiveness of sunscreen largely relies on its correct and thorough application.

Findings

We identified minor compliance deficiencies related to labelling, advertising and record-keeping for a third of sunscreens we reviewed. We take regulatory action when we identify such deficiencies. In this case, the issues were corrected by the product sponsor and no further regulatory action was required, with the products able to remain on the Australian Register of Therapeutic Goods (ARTG).

One third of sunscreens reviewed were cancelled from the ARTG, in most cases by the product sponsor. Most of these cancellations were because the products were formulated with amounts of the antimicrobial preservatives methylisothiazolinone (MI) and methylchloroisothiazolinone (MCI) to comply with a standard that has since been updated to tighten the permitted limits for these ingredients. Such products would have had to be reformulated to remain on the ARTG. As described in the Restrictions on quantity of preservative ingredients section below, the new quantity restrictions for MI and MCI took effect on 1 October 2017 to provide a greater safety margin for consumers. We identified all sunscreens on the ARTG which contained these ingredients and contacted the sponsors at the start of this review.

We identified only 2 products (2%) for which the SPF or broad spectrum claims on the sunscreen were not supported by a complete dossier of SPF and broad spectrum testing results. These 2 products have been cancelled from the ARTG. Neither was required to be recalled from sale as we held no major concerns about the effectiveness of these products.

Overall we identified no major compliance issues and we hold no concerns regarding the effectiveness of sunscreens currently available on the Australian market. However, our review has highlighted the importance of increasing consumer understanding relating to the safe and effective application of sunscreens.

General information about sunscreens

In Australia, most sunscreens are regulated by the TGA as therapeutic goods. These products are referred to as therapeutic sunscreens. Sunscreens not regulated by the TGA include cosmetic sunscreens and sunscreens with an SPF less than 4.

Sunscreen products do not block 100% of harmful ultraviolet (UV) radiation. Ingredients in sunscreens act as filters that prevent varying amounts of radiation from reaching the skin; no matter how high the SPF, skin will burn if exposed to the sun for extended periods. The TGA has reviewed the labelling of sunscreens to ensure consumers are not led to believe that sunscreen products completely or indefinitely block radiation from the sun. The TGA takes regulatory action if such a labelling breach is identified.

Sunscreen labels

Sunscreen labels are required to include clear and adequate directions for use as specified in the Standard. Labels are also required to comply with all labelling requirements for therapeutic goods. These requirements specify what information must be included on the labels. This includes storage conditions and relevant advisory or warning statements about particular ingredients.

Aerosol spray sunscreens

Aerosol sunscreens have been a recent addition to the sunscreen market, gaining popularity due to their novel and convenient application system. However, there have been reports of serious sunburn incidents following application of aerosol sunscreens in past summers.

Our laboratory test results for 31 Australian sunscreens showed that the amount of product delivered per second varied between brands of aerosol sunscreens. Consumers must account for inter-brand variations by applying the product liberally to achieve full coverage.

During our recent compliance review of sunscreens, we found that the test data provided by sponsors supported the broad spectrum and SPF claims of aerosol sunscreens. We also confirmed that these claims were compliant with the current Standard. However, it must be emphasised that this testing is conducted on the sunscreen formulation that does not have the propellant added.

Aerosol sunscreens are mixed with propellant in the sunscreen container (e.g. an aerosol can) and may be more dilute than an equivalent volume found in a sunscreen lotion. This means that consumers may have to use a greater amount of an aerosol compared to a lotion or cream to achieve the same coverage.

To get the most protection from an aerosol sunscreen, we encourage consumers to spray a liberal amount evenly on their skin by spraying it into their hands first, then applying it to their skin. This can then be applied to the face in a similar manner to applying a lotion. Reapply liberally every 2 hours especially after swimming, excessive perspiration or towelling.

Advice for applying sunscreen effectively

Sunscreen should always be applied according to the instructions for use on the label and recommendations set out by the Cancer Council in conjunction with the Australasian College of Dermatologists. It is important to be SunSmart by not relying on sunscreen alone. Remember to slip on the shirt, slop on the sunscreen, slap on a hat, slide on the sunglasses and seek shade.

Lotions

At least 1 teaspoon of sunscreen (approximately 5 mL) should be applied to each area (arm, leg, back, etc.). The same amount should be reapplied at least every 2 hours, especially after swimming or towelling. More frequent application is required when activities in the water or that cause perspiration are undertaken. Claims or labels that imply otherwise may be misleading.

Aerosols

Adults should apply 35 - 40 mL of sunscreen to the whole body in a single application to achieve adequate protection. The average can of aerosol sunscreen contains approximately 90 - 100 mL of sunscreen formulation, excluding the propellant. This means that approximately 1/3 of a can of aerosol is required for a single application to cover the whole body.

Skin reactions to sunscreens

The TGA puts measures in place to protect Australians from ingredients proven to increase the risk of skin sensitivity or other safety issues and adverse reactions. These measures include limiting the permissible quantity of some preservatives.

We reviewed the product formulations to assess whether all ingredients, including excipients, were present at levels that comply with regulatory requirements. We found no formulation issues that present sensitivity concerns to general members of the public. However, we would like to emphasise that some individuals may be more sensitive to ingredients found in sunscreens, just like any other cosmetic or skin treatment they may use.

When using a particular sunscreen product for the first time, SunSmart advises applying a small amount of product to a test patch of skin near the elbow on the forearm. This may help to avoid skin reactions in infants and children, who have more sensitive skin than adults. The Australasian College of Dermatologists recommends that the use of sunscreen should be minimised for infants below 6 months of age due to the sensitive nature of newborn and infant skin. If sunscreen must be used on infants under 6 months of age, a healthcare professional should be consulted. Further information can be found on the SunSmart sunscreen information sheet.

Restrictions on preservative ingredients

A small number of sunscreens contain methylisothiazolinone (MI) and methylchloroisothiazolinone (MCI), antimicrobial preservatives that are permitted for use in many products including sunscreens and cosmetics. MI & MCI prevent microbial growth throughout the product’s shelf life.

On 1 October 2017, and consistent with international standards, the TGA imposed tighter restrictions on the amounts of these ingredients that can be present in sunscreen products. This restriction provides 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.

Sunscreens containing MI and MCI manufactured from 1 October 2017 must comply with the new quantity restriction. This was assessed as part of our compliance review.

Currently, there are no concerns associated with existing products (manufactured before 1 October 2017) on the market that contain the slightly higher quantities of MI and MCI. Should serious safety concerns arise about a product already on the market, the TGA will take measures to recall the product in question.

Reporting reactions and other issues to the TGA

The TGA receives reports of suspected adverse events involving sunscreens each summer. Reports often describe problems with effectiveness or potential skin reactions.

Reporting adverse events to the TGA allows us to monitor the safety of medicines, including sunscreens. This helps us to gain a better understanding of their possible side effects and limitations associated with particular products. It can be difficult to conclusively determine the cause of suspected adverse events due to the number of potential contributing factors, which include application errors and potential allergic reactions to certain ingredients. Despite this, all reports are extremely valuable in helping us identify any underlying problems.

Consumers and health professionals are encouraged to report any problems with sunscreens and other medicines or vaccines, as these will contribute to the TGA's ongoing monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.