Chemists' Own Sport Sunscreen Lotion SPF50+ (Arrow Pharma Pty Ltd)
Product Name
Chemists' Own Sport Sunscreen Lotion SPF50+
Sponsor
ARTG
283282
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, follow the recommended actions below.
What action should consumers take?
None
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 no longer permitted for use in listed medicines. It may cause skin sensitisation, including redness and allergic dermatitis.
However, no batches of this sunscreen were supplied after the ingredient was not permitted to be used and the last batch expired in June 2023. Therefore, this sunscreen is unlikely to pose an immediate risk to consumer health and safety.
However, no batches of this sunscreen were supplied after the ingredient was not permitted to be used and the last batch expired in June 2023. Therefore, this sunscreen is unlikely to pose an immediate risk to consumer health and safety.
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