Bondi Sands SPF 50+ Face Mist (Bondi Sands Pty Ltd)
Product Name
Bondi Sands SPF 50+ Face Mist
Sponsor
ARTG
364522
Date of review outcome
Date of publication
Jun-2024
Outcome
Sunscreen is no longer permitted to be supplied and has been recalled by the sponsor
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?
This sunscreen's name implies it is suitable for use on the face. Be aware that this sunscreen's directions for use have been revised:
Shake can well before use. Make sure you are in a well-ventilated area to avoid inhalation. Do not apply the product in windy conditions.
Hold the can 10-15 cm away from the body and spray liberally and evenly until the product looks and feels wet on the skin. Do not spray directly onto the face, instead spray onto hands and then apply to the face.
Re-apply every 2 hours or more often when sweating and after swimming, exercise or towel drying.
For further instructions, please go to the safety alerts page on the TGA website (https://www.tga.gov.au/safety/product-recalls/bondi-sands-everyday-protection-face-spf-50-sunscreen-mist-updated-directions-use).
Shake can well before use. Make sure you are in a well-ventilated area to avoid inhalation. Do not apply the product in windy conditions.
Hold the can 10-15 cm away from the body and spray liberally and evenly until the product looks and feels wet on the skin. Do not spray directly onto the face, instead spray onto hands and then apply to the face.
Re-apply every 2 hours or more often when sweating and after swimming, exercise or towel drying.
For further instructions, please go to the safety alerts page on the TGA website (https://www.tga.gov.au/safety/product-recalls/bondi-sands-everyday-protection-face-spf-50-sunscreen-mist-updated-directions-use).
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Evidence, Labels, Manufacturing Documentation, Website
Issues related to safety
The directions for use on the label and website for this sunscreen did not provide sufficient instructions for its use on the face. Directly spraying an aerosol sunscreen onto the face may result in inadvertent inhalation, local irritation of the upper airways, coughing and sneezing.
All affected batches of this sunscreen were recalled, supply was ceased, and the sponsor has communicated the updated directions for use to consumers. As such, this sunscreen is unlikely to pose an immediate risk to consumer health and safety.
All affected batches of this sunscreen were recalled, supply was ceased, and the sponsor has communicated the updated directions for use to consumers. As such, this sunscreen is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The directions for use on the label and website for this sunscreen did not provide sufficient instructions for how to use it effectively
Actions taken during the review
The TGA required the sponsor to correct the issues with this sunscreen. The sponsor recalled all batches of this sunscreen from the market, cancelled, and withdrew it from further supply. The sponsor also communicated the revised directions for use for this sunscreen to consumers.
Additional information
This sunscreen was targeted to check its compliance with safety and efficacy requirements