Key Sun Clear Zinke SPF50+ (Key-Sun Laboratories Pty Ltd)
Product Name
Key Sun Clear Zinke SPF50+
Sponsor
ARTG
275540
Date of review outcome
Date of publication
Sep-2023
Outcome
Sunscreen is no longer permitted to be supplied
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 (4-(4-hydroxy-4-methylpentyl)-3-cyclohexene carboxaldehyde), 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 updated the formulation of this sunscreen to correct the issue. The sponsor subsequently cancelled this sunscreen and withdrew it from further supply.
Additional information
This sunscreen was targeted to check the presence of HICC in the product