Salt & Stone SPF50 Mineral Based Sunscreen Lotion (Onboard Industries Pty Ltd)
Product Name
Salt & Stone SPF50 Mineral Based Sunscreen Lotion
Sponsor
ARTG
302229
Date of review outcome
Date of publication
Jun-20
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, however use of the medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
Consider whether the medicine is right for you if you have allergies or sensitivities to phenoxyethanol or preservatives. If irritation develops discontinue use and consult a suitably qualified health practitioner.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The medicine contains the ingredient phenoxyethanol which was not declared on the label. Phenoxyethanol, a preservative, is required to be declared on the labels of medicines as it may cause adverse reactions in individuals with allergies or sensitivities to this substance. However, current data indicates that allergic reactions to phenoxyethanol are rare and the quantity in the medicine is unlikely to pose an immediate risk to consumers.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
TGA required the sponsor to correct the issues with the medicine. The sponsor cancelled the medicine and withdrew it from further supply.