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Class III: unlikely to cause harmTerminated

CLINIQUE moisture surge tinted moisturizer Recall

CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL

Clinique International · New York, NY

Risk level
Class III
Reported by FDA
Sep 7, 2016
Recall ID
D-1475-2016
Check your lot numberHow we source this data

Summary

Clinique International recalled CLINIQUE moisture surge tinted moisturizer starting May 17, 2016. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1475-2016 on Sep 7, 2016. Reason: Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay. Status: Terminated.

Why it was recalled

Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.

Product description

CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47478-2, Shade 03 (MF-N)

Lot numbers, UPCs & expiration codes

all lots

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1475-2016
Classification
Class III
Status
Terminated
Recall initiated
May 17, 2016
FDA report date
Sep 7, 2016
Quantity
1,771,244 bottles for all shades
Recall type
Voluntary: Firm initiated
Recalling firm
Clinique International

Original FDA data

Every field from FDA enforcement report D-1475-2016, exactly as published.

Show all FDA fields
City
New York
State
NY
Status
Terminated
Country
United States
Event ID
74746
Address
767 5th Ave
Code information
all lots
Postal code
10153-0023
Report date
Sep 7, 2016
Product type
Drugs
Recall number
D-1475-2016
Classification
Class III
Recalling firm
Clinique International
Product quantity
1,771,244 bottles for all shades
Termination date
Jun 14, 2018
Reason for recall
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Voluntary / mandated
Voluntary: Firm initiated
Product description
CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47478-2, Shade 03 (MF-N)
Distribution pattern
Nationwide
Recall initiation date
May 17, 2016
Initial firm notification
E-Mail
Center classification date
Aug 26, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1475-2016, published Sep 7, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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