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EGO SUNSENSE ULTRA (Ego Pharmaceuticals Pty Ltd)
Product Name
EGO SUNSENSE ULTRA
Sponsor
ARTG
194260
Date of review outcome
Date of publication
Jun-20
Outcome
Sunscreen is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
If you are using this sunscreen, ensure you apply it 20 minutes prior to sun exposure
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Manufacturing Documentation, Website
Issues related to safety
The directions for use instructed consumers to apply the product 15 minutes prior to sun exposure as opposed to 20 minutes prior to sun exposure. It is important to ensure adequate time between application and sun exposure to maximise ultraviolet protection. However, the five minute difference is unlikely to pose an immediate safety risk to consumers.
Issues related to efficacy
The efficacy of the sunscreen was not assessed as part of this review
Actions taken during the review
TGA required the sponsor to correct the issues with the sunscreen. The sponsor cancelled the sunscreen and withdrew it from further supply.