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Type of Product Medicine
TGA Recall Reference RC-2022-RN-00625-1
Product Name/Description Baby Bum Mineral SPF50+ Lotion

Lot numbers: N1118B and N1118C

Expiry date: 04/2024

ARTG 355134
Recall Action Level Consumer
Recall Action Classification Class II
Recall Action Commencement Date 26/04/2022
Responsible Entity Sun Bum Pty Ltd
Reason/Issue Sun Bum are informing of benzene contamination in one of the raw materials has led to low level contamination of some sunscreen finished goods. Two lot numbers containing the contaminated material had benzene above the acceptable limit.

Benzene is a Class 1 residual solvent, which should not be employed in the manufacture of drug substances, excipients, and drug products because of its unacceptable toxicity (it is a recognised carcinogen).

This action does not affect any other batches of the Baby Bum products. The two lot numbers have been distributed to pharmacies and retailers since 1 August 2021.
Recall Action Recall
Recall Action Instructions Sun Bum ae advising:

Distributors and Retailers:
- Inspect the stock immediately and quarantine affected stock.
- Follow disposal or return instructions outlined in the customer letter (will be provided only to the impacted customers) for the credit.

Consumers:
- Stop using the affected product.
- Visit the Baby Bum recall website at babybumrecallanz.com to request a refund and then discard the product.
Contact Information 1800 95 3664 - Customer service - Sun Bum