OMBRA SPF50+ Ultra Sunscreen Lotion (Ross Laboratories Aust Pty Ltd)
Product Name
OMBRA SPF50+ Ultra Sunscreen Lotion
Sponsor
ARTG
319653
Date of review outcome
Date of publication
Sep-2023
Outcome
Sunscreen continues to be permitted for supply. Batches released from 11 November 2022 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 medicine 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.
Additional information
This sunscreen was targeted to check the presence of HICC in the product