OMBRA BEACH Invisible Sunscreen Spray SPF50+ (Baxter Laboratories Pty Ltd)
Product Name
OMBRA BEACH Invisible Sunscreen Spray SPF50+
Sponsor
ARTG
279839
Date of review outcome
Date of publication
Dec-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?
This medicine contains Benzoates. Consider whether the medicine is right for you if you have allergies or sensitivities to this substance. If you develop a reaction, discontinue use and consult a suitably qualified health practitioner.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Laboratory Results, Manufacturing Documentation
Issues related to safety
The medicine contains benzoates, which were not declared on the label. Benzoates are required to be declared on the labels of medicines as they may cause adverse reactions in individuals with allergies or sensitivities to this group of substances. However, the label includes the statement ‘Avoid contact with eyes and discontinue use if rash or irritation develops’, which alerts consumers to the possibility of irritation from this medicine.
Issues related to efficacy
None
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.