Sun Plus Luxe Sunscreen (Nowra Chemical Manufacturers Pty Ltd T/A Nowchem Pharma)
Product Name
Sun Plus Luxe Sunscreen
ARTG
290508
Date of review outcome
Date of publication
Mar-21
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?
Do not use this medicine because it is past its expiry date
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record
Issues related to safety
The medicine contains the preservatives methylchloroisothiazolinone and methylisothiazolinone, which are only permitted for use in 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 to consumers is increased. However, these medicines were withdrawn from supply in May 2020 and did not pose an immediate risk to consumer health and safety.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 sponsor cancelled the medicine and withdrew it from further supply. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with the medicine.
Additional information
This medicine was targeted to check its compliance in relation to the ingredients methylchloroisothiazolinone and methylisothiazolinone