Invisible Zinc Tinted Daywear Mineral Shield SPF 30 Light (iNova Pharmaceuticals (Australia) Pty Ltd)
Product Name
Invisible Zinc Tinted Daywear Mineral Shield SPF 30 Light
ARTG
173395
Date of review outcome
Date of publication
Jun-22
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
No, continued use is not recommended as its safety is not considered acceptable for a listed medicine
What action should consumers take?
Stop using this medicine immediately. Seek advice from a healthcare practitioner if you develop skin irritation.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels
Issues related to safety
The medicine contains the preservatives methylisothiazolinone and methylchloroisothiazolinone, which are only permitted for listed medicines that are applied and then rinsed-off the skin. These preservatives may cause skin sensitisation, including redness and allergic dermatitis. As this medicine is intended to be left-on the skin, the risk of sensitisation reactions is increased. However, this medicine was withdrawn from supply in June 2021 and therefore does not pose an immediate risk to consumer health and safety.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor cancelled the medicine and withdrew it from further supply.
Additional information
This medicine was targeted to check its compliance in relation to the ingredients methylisothiazolinone and methylchloroisothiazolinone