Ultra Protect SPF50+ Sunscreen (Concept Laboratories Pty Ltd)
Product Name
Ultra Protect SPF50+ Sunscreen
Sponsor
ARTG
319293
Date of review outcome
Date of publication
Jun-2024
Outcome
Sunscreen is no longer permitted to be supplied
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?
Be aware that this sunscreen was marketed under different names, some of which were similar to other sunscreens that contain different ingredients. Check the label if you are allergic or sensitive to specific ingredients.
Consider whether this sunscreen is right for you based on it potentially not working as expected in relation to claims that it can 'protect against free radical induced skin damage' and 'helps reduce skin irritation, redness and swelling'.
Consider whether this sunscreen is right for you based on it potentially not working as expected in relation to claims that it can 'protect against free radical induced skin damage' and 'helps reduce skin irritation, redness and swelling'.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Manufacturing Documentation
Issues related to safety
The inconsistent marketing described in 'What action should consumers take?' makes it difficult for consumers to correctly identify this sunscreen. This may pose a safety risk for consumers with allergies or sensitivities to certain ingredients in this sunscreen.
This sunscreen was labelled in a facility that does not hold a licence to perform this manufacturing step for therapeutic goods.
Supply of this sunscreen ceased in September 2021 and therefore it is unlikely to pose an immediate risk to consumers health and safety.
This sunscreen was labelled in a facility that does not hold a licence to perform this manufacturing step for therapeutic goods.
Supply of this sunscreen ceased in September 2021 and therefore it is unlikely to pose an immediate risk to consumers health and safety.
Issues related to efficacy
There are sunscreens marketed under AUST L 319293 that claim it could protect against free radical induced skin damage and help reduce skin irritation, redness and swelling. However, these claims were not covered by the sponsor's certification that they held evidence to substantiate them.
Actions taken during the review
The sponsor cancelled this medicine and withdrew it from further supply. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with this medicine.