Health product recall

Ombrelle product recall (2021-10-13)

Starting date:
October 13, 2021
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-76673



Last updated:
2021-10-19

Summary

  • Product:
    A. Complete Dry Mist Spray Hypoallergenic UVA + UVB SPF 30

    B. Complete Dry Mist Spray

A. Complete Dry Mist Spray Hypoallergenic UVA + UVB SPF 30

B. Complete Dry Mist Spray

Reason

Affected lots potentially contain a concentration of benzene that is outside the allowable limit for this type of product.

Depth of distribution

Retailers, Wholesalers

Affected products

A. Complete Dry Mist Spray Hypoallergenic UVA + UVB SPF 30

DIN, NPN, DIN-HIM

DIN 02415313

Dosage form

Aerosol

Strength

Avobenzone 2.96%/W/W                                                     Homosalate 8.78%/W/W                                                        Octisalate 4.88%/W/W                                                                Octocrylene 5.92%/W/W

Lot or serial number

JFT30W, JFS80W

Companies

Recalling Firm

L'Oreal Canada

4895 Hickmore

Montreal

H4T 1K5

Quebec

CANADA

Marketing Authorization Holder

Ombrelle Canada

4895 Hickmore

Montreal

H4T 1K5

Quebec

CANADA


B. Complete Dry Mist Spray

DIN, NPN, DIN-HIM

DIN 02415402

Dosage form

Spray 

Strength

Avobenzone 3%/W/W                                                              Homosalate 10.72%/W/W                                                      Octisalate 3.21%/W/W                                                        Octocrylene 6%/W/W                                                          Oxybenzone 3.86%/W/W

Lot or serial number

JFU30W, JFT30W, JFS80W, JFS81W

Companies

Recalling Firm

L'Oreal Canada

4895 Hickmore

Montreal

H4T 1K5

Quebec

CANADA

Marketing Authorization Holder

Ombrelle Canada

4895 Hickmore

Montreal

H4T 1K5

Quebec

CANADA