Drug Enforcement D-151-2013

Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stable over the shelf life, the sunscreen effectiveness may be less than labeled.

Status

Terminated

Classification

Class III

Report Date

February 13, 2013

Termination Date

April 3, 2017

Product Information

Product description
ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxidant Moisturizer Broad Spectrum SPF15, All Skin types, 1.7 FL. OZ. LIQ/50 ml (tube inside a unit carton) with UPC No. 2713179904, Code WKEM-01, and 1.5 mL foil sample packets, ESTEE LAUDER, DIST., NEW YORK, N.Y. 10022 NDC 11559-008-01
Product quantity
1.7 oz. 241,236 tubes; 1.5 mL sample size 544,548 foil packs
Reason for recall
Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stable over the shelf life, the sunscreen effectiveness may be less than labeled.
Recall initiation reason
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution pattern
Nationwide, Puerto Rico, Bermuda and Panama

Location & Firm

Recalling firm
Estee Lauder Inc
Address
767 5th Ave Fl 47th, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-151-2013
Event ID
63510
Recall initiation date
October 23, 2012
Center classification date
February 5, 2013
Code info
A70, A80, AA0, B11, A31, A51, B51, A81, A91, A12, A22, A72, BA0, AB0, BB0, CB0, AC0, BC0, A11, A21, B21, B31, A41.
More code info