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SunSeal by Microskin SPF 50+ Sunscreen (Blonde Holdings Pty Ltd)
Product Name
SunSeal by Microskin SPF 50+ Sunscreen
Sponsor
ARTG details
Date of review outcome
Date of publication
Jun-2025
Outcome
Sunscreen continues to be permitted for supply. One batch of this sunscreen (213UK1) has been recalled by the sponsor.
Is it safe to continue using this medicine?
Yes, based on the sponsor’s certification. However, follow the recommended actions below.
What action should consumers take?
The affected batch of this sunscreen (213UK1) expired on 21 March 2024. Do not use this sunscreen as it has passed its expiry date.
Review scope
Targeted
Information reviewed
ARTG Record, Advertising (other), Labels, Manufacturing Documentation, Website
Issues related to safety
One batch of this sunscreen was manufactured at a facility that does not carry the appropriate licence to manufacture this sunscreen.
The websites for this sunscreen contained claims that it provided three days coverage and is waterproof. Additionally, the labels for this sunscreen did not contain the instructions to reapply frequently. Advertising of this nature may result in less effective sun protection in preventing sunburn and skin cancer. While advertising of this nature is unacceptable, the last batch of this sunscreen expired on 21 March 2024, and the websites and label for this sunscreen have been updated.
The affected batch was recalled and is unlikely to pose a further risk to consumer health and safety.
The websites for this sunscreen contained claims that it provided three days coverage and is waterproof. Additionally, the labels for this sunscreen did not contain the instructions to reapply frequently. Advertising of this nature may result in less effective sun protection in preventing sunburn and skin cancer. While advertising of this nature is unacceptable, the last batch of this sunscreen expired on 21 March 2024, and the websites and label for this sunscreen have been updated.
The affected batch was recalled and is unlikely to pose a further risk to consumer health and safety.
Issues related to efficacy
The efficacy of this sunscreen was not assessed as part of this review
Actions taken during the review
The sponsor recalled this sunscreen from the market and updated the advertising, ARTG record and label for this sunscreen.
The TGA issued an educational letter to the sponsor outlining the issues with this sunscreen. The sponsor was not required to respond but was expected to correct the issues.
The TGA issued an educational letter to the sponsor outlining the issues with this sunscreen. The sponsor was not required to respond but was expected to correct the issues.