Drug product
LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade DARK 04, UPC 7 47930 00483 7 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM
D-816-2013
Product summary
- Event
- Event 65629
- Status
- Terminated
- Classification
- Class III
- Quantity
- 49,845 tubes (total for all products)
- Official record key
drug-enforcement:D-816-2013
Official wording
Reason: Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Code information: all lots currently in the market shipped before June 2013
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent