Drug recall: ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxidant Moisturizer Broad Spectrum SPF15, All Sk

FDA enforcement event 63510 · Class III · initiated 23 Oct 2012 · status Terminated · terminated 3 Apr 2017

DrugVoluntary: Firm initiated1 product recordNew York, NY

Estee Lauder Inc (New York, NY) initiated this drug recall on 23 Oct 2012; FDA lists 1 product record under event 63510, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 28% of the 209 drug enforcement events initiated in 2012 carry the same class.

Status: Terminated, terminated 3 Apr 2017. Initiation: voluntary: firm initiated. Estee Lauder Inc has 3 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Estee Lauder Inc, New York, NY.

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."

Distribution

"Nationwide, Puerto Rico, Bermuda and Panama"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-151-2013	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	1.7 oz. 241,236 tubes; 1.5 mL sample size 544,548 foil packs	Class III	Terminated	13 Feb 2013

Context

28%of 2012 drug events are Class III209 events that year

1product record in this eventfirm median: 1

3events on this register for the firm

Other enforcement events for Estee Lauder Inc

Initiated	Product (first record)	Type	Class	Records
15 Mar 2019	Repairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15, packaged in a light green folding carton containing a	Drug	Class III	1
6 Jun 2014	DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laborato	Drug	Class III	1

All 3 events for Estee Lauder Inc

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "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."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide, Puerto Rico, Bermuda and Panama"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 3 Apr 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.