Drug Enforcement D-814-2013

Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled

Status

Terminated

Classification

Class III

Report Date

July 31, 2013

Termination Date

May 18, 2018

Product Information

Product description
LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade LIGHT 02, UPC 7 47930 00481 3, MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM
Product quantity
49,845 tubes (total for all products)
Reason for recall
Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and 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

Location & Firm

Recalling firm
Max Huber Research Labs, Inc.
Address
767 Fifth Avenue, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-814-2013
Event ID
65629
Recall initiation date
June 27, 2013
Center classification date
July 22, 2013
Code info
all lots currently in the market shipped before June 2013
More code info