CLASS III Drug recall · Reported 7 Sep 2016 · FDA Enforcement Report
Clinique moisture surge tinted moisturizer broad spectrum recalled
Clinique International is recalling Clinique moisture surge tinted moisturizer broad spectrum SPF 15LIQ./ bottle within a, distributed nationwide in the US. The recall was initiated on 17 May 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1478-2016
- FDA event ID
- 74746
- Recalling firm
- Clinique International, New York, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 May 2016
- FDA classified
- 26 Aug 2016
- Reported
- 7 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Sunscreen & Personal Care
Timeline
| 17 May 2016 | Recall initiated by company | |
| 26 Aug 2016 | Classified by FDA | +101 days |
| 7 Sep 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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. 20714-48241-1, Shade 06 (D-G)
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug: Two of the active sunscreen ingredients, octinoxate and octisalate, are below the specifications for assay.
Which lots are affected?
all lots
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 74746This product is part of a recall event; the main page for the event is Clinique moisture surge tinted moisturizer broad spectrum recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Clinique moisture surge tinted moisturizer broad spectrum recalled | Clinique International | Potency & Assay | Nationwide | |
| CLASS III | Clinique moisture surge tinted moisturizer broad spectrum recalled | Clinique International | Potency & Assay | Nationwide | |
| CLASS III | Clinique moisture surge tinted moisturizer broad spectrum recalled | Clinique International | Potency & Assay | Nationwide | |
| CLASS III | Clinique moisture surge tinted moisturizer broad spectrum recalled | Clinique International | Potency & Assay | Nationwide | |
| CLASS III | Clinique moisture surge tinted moisturizer broad spectrum recalled | Clinique International | Potency & Assay | Nationwide |
More recalls from Clinique International
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Clinique moisture surge tinted moisturizer broad spectrum recalled | Clinique International | Potency & Assay | Nationwide |
| Drug | CLASS III | Clinique moisture surge tinted moisturizer broad spectrum recalled | Clinique International | Potency & Assay | Nationwide |
| Drug | CLASS III | Clinique moisture surge tinted moisturizer broad spectrum recalled | Clinique International | Potency & Assay | Nationwide |
| Drug | CLASS III | Clinique moisture surge tinted moisturizer broad spectrum recalled | Clinique International | Potency & Assay | Nationwide |
| Drug | CLASS III | Clinique moisture surge tinted moisturizer broad spectrum recalled | Clinique International | Potency & Assay | Nationwide |