Coles SPF50+ Ultra Sunscreen (Baxter Laboratories Pty Ltd)
Product Name
Coles SPF50+ Ultra Sunscreen
Sponsor
Date of review outcome
Date of publication
Mar-2024
Outcome
Sunscreen continues to be permitted for supply. Batches released from 6 October 2023 must not contain HICC (4-(4-hydroxy-4-methylpentyl)-3-cyclohexene carboxaldehyde).
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, use of this sunscreen may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
This sunscreen contains HICC. Consider whether this 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 (see Additional Information below)
Information reviewed
ARTG Record
Issues related to safety
This sunscreen contains HICC, which is an ingredient that is not permitted for use in listed medicines. It may cause skin sensitisation, including redness and allergic dermatitis.
However, current data indicates that the amount of HICC in this sunscreen is unlikely to pose an immediate risk to consumers.
However, current data indicates that the amount of HICC in this sunscreen is unlikely to pose an immediate risk to consumers.
Issues related to efficacy
The efficacy of this sunscreen was not assessed as part of this review
Actions taken during the review
The TGA required the sponsor to correct the issue with this sunscreen. The sponsor provided more information about this sunscreen. The TGA imposed a condition on this sunscreen requiring that no further batches containing HICC are released into the market.
Additional information
This sunscreen was targeted to check the presence of HICC in the product