MIL-OSI Australia: Multiple Sunscreens Recall – Low levels of benzene detected

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Source: Australian Department of Health

Recalls due to detection of benzene

Consumers and health professionals are advised that a number of sunscreen products, which are regulated as medicines in Australia, are being recalled due to the presence of benzene.

What Should I Do?

Check the table of products set out below.

Only the batches included in the table are being recalled.

If you have any of the affected batch numbers, please return it to the place of purchase or contact the Sponsor (their contact details are in the table) for a refund.

Other products may be added to the table in the next few weeks as the TGA investigations continue. We will update this information if additional products are identified and recall actions start.

If you have any concerns or questions about benzene and use of sunscreens, please speak to your health professional.

What is benzene and what are the risks?

Benzene is a chemical that can cause cancer in humans, depending on the level and length of exposure. Benzene is not an ingredient in sunscreens but can be a contaminant in raw materials used in the manufacturing process. It has been detected in one batch of a raw material used in the manufacture of a number of products and the TGA is working with affected companies to confirm if benzene is present in their medicines and if it is, how much is there.

Benzene levels in sunscreens sold in Australia must be below 2 parts per million (ppm). Although exposure at the levels detected would not be expected to cause serious adverse health effects, and risks to users are considered low, the sunscreens are being recalled to ensure consumer safety.

Product name (ARTG number) Sponsor Affected Batch numbers Sponsor contact details

Cancer Council Sensitive Sunscreen SPF50+ 110mL (Tube)

(AUST L 278913)

VitalityBrands Worldwide Pty Ltd

Batch: 1103178

1300 364 515

Cancer Council Sensitive Sunscreen SPF50+ 200mL (Pump)

(AUST L 278913)

VitalityBrands Worldwide Pty Ltd

Batch: 1099751

1300 364 515

NIVEA Sun Protect & Moisture SPF30 Lotion 200ml

(AUST L 270876)

Beiersdorf Australia Ltd

SPF30 lotion batch: 12640440-BN

Beiersdorf Customer Service Manager – (02) 98880853

NIVEA Sun Protect & Moisture SPF50+ Roll On 65ml

(AUST L 286352)

Beiersdorf Australia Ltd

SPF50+ roll on batch: 12669940BN

Beiersdorf Customer Service Manager – (02) 98880853

SPF 50+ Lotion Spray Coconut Beach 200ml

(AUST L 354358)

Bondi Sands Pty Ltd

104263, 1104743 and 1104264

1300 961 385 – Bondi Sands Customer Service Line

Baby Bum Mineral SPF50+ Lotion 88mL

(AUST L 355134)

Sun Bum Pty Ltd

N1118B and N1118C

1800 95 3664

Sun Bum

Customer Service Centre

The TGA published information in 2021 on recalls of two other sunscreens due to benzene contamination – please see:

‘Banana Boat’ Sunscreen Sprays SPF 50+ (aerosol sunscreen)

and

Neutrogena Ultra Sheer Body Mist Sunscreen Spray SPF 50+ (aerosol sunscreen).

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA’s monitoring of these products.

The TGA cannot give advice about an individual’s medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.

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