CLASS III Drug recall · Reported 31 Jul 2013 · FDA Enforcement Report
LA MER the spf 18 fluid tint , broad spectrum spf 18 liq. recalled
Max Huber Research Labs is recalling LA MER the spf 18 fluid tint , broad spectrum spf 18 liq./, Shade DARK 04, distributed nationwide in the US. The recall was initiated on 27 Jun 2013 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-816-2013
- FDA event ID
- 65629
- Recalling firm
- Max Huber Research Labs, New York, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Jun 2013
- FDA classified
- 22 Jul 2013
- Reported
- 31 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Sunscreen & Personal Care
Timeline
| 27 Jun 2013 | Recall initiated by company | |
| 22 Jul 2013 | Classified by FDA | +25 days |
| 31 Jul 2013 | Published in enforcement report | +9 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: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
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
LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade DARK 04, UPC 7 47930 00483 7 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Which lots are affected?
all lots currently in the market shipped before June 2013
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
2 other products · FDA event 65629This product is part of a recall event; the main page for the event is LA MER the spf 18 fluid tint , broad spectrum spf 18 liq. recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | LA MER the spf 18 fluid tint , broad spectrum spf 18 liq. recalled | Max Huber Research Labs | Potency & Assay | Nationwide | |
| CLASS III | LA MER the spf 18 fluid tint , broad spectrum spf 18 liq. recalled | Max Huber Research Labs | Potency & Assay | Nationwide |
More recalls from Max Huber Research Labs
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | LA MER the spf 18 fluid tint , broad spectrum spf 18 liq. recalled | Max Huber Research Labs | Potency & Assay | Nationwide |
| Drug | CLASS III | LA MER the spf 18 fluid tint , broad spectrum spf 18 liq. recalled | Max Huber Research Labs | Potency & Assay | Nationwide |