Drug product
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
D-151-2013
Product summary
- Firm
- Estee Lauder Inc
- Event
- Event 63510
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1.7 oz. 241,236 tubes; 1.5 mL sample size 544,548 foil packs
- Official record key
drug-enforcement:D-151-2013
Official wording
Reason: 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.
Code information: A70, A80, AA0, B11, A31, A51, B51, A81, A91, A12, A22, A72, BA0, AB0, BB0, CB0, AC0, BC0, A11, A21, B21, B31, A41.
Distribution pattern: Nationwide, Puerto Rico, Bermuda and Panama
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications