Skip to content
Recall Observatory FDA recall evidence

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

October 23, 2012

Class III

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

    reason.potency_specification_failure · v1.0.0

    Failed Stability Specifications