CLASS II Drug recall · Reported 24 Jan 2018 · FDA Enforcement Report
bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion recalled
Shiseido America is recalling bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide, distributed nationwide in the US. The recall was initiated on 14 Dec 2017 and the FDA has classified it as Class II.
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-0214-2018
- FDA event ID
- 78791
- Recalling firm
- Shiseido America, East Windsor, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Dec 2017
- FDA classified
- 12 Jan 2018
- Reported
- 24 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Processing Deviation
- Drug class
- Creams, Ointments & Gels
Timeline
| 14 Dec 2017 | Recall initiated by company | |
| 12 Jan 2018 | Classified by FDA | +29 days |
| 24 Jan 2018 | 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
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottle, Dist. by Bare Escentuals Beauty, Inc. SF, CA 94105 USA, NDC 98132-761-01
Where it was distributed
Product was distributed nationwide.
Questions about this recall
Why was it recalled?
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Which lots are affected?
SKU#: BE8047201
Where was it sold?
Product was distributed 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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
4 other products · FDA event 78791This product is part of a recall event; the main page for the event is Shiseido Future Solution LX Universal Defense SPF 50+ recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Shiseido Future Solution LX Universal Defense SPF 50+ recalled | Shiseido America | Processing Deviation | Nationwide | |
| CLASS II | Shiseido Future Solution LX Discovery Set contains SPF 50+ recalled | Shiseido America | Processing Deviation | Nationwide | |
| CLASS II | Shiseido Future Solution LX Luxurious Eye & Lip Collection recalled | Shiseido America | Processing Deviation | Nationwide | |
| CLASS II | Shiseido Future Solutions LX Triple Points Bonus contains recalled | Shiseido America | Processing Deviation | Nationwide |
More recalls from Shiseido America
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Shiseido Future Solutions LX Triple Points Bonus contains recalled | Shiseido America | Processing Deviation | Nationwide |
| Drug | CLASS II | Shiseido Future Solution LX Luxurious Eye & Lip Collection recalled | Shiseido America | Processing Deviation | Nationwide |
| Drug | CLASS II | Shiseido Future Solution LX Discovery Set contains SPF 50+ recalled | Shiseido America | Processing Deviation | Nationwide |
| Drug | CLASS II | Shiseido Future Solution LX Universal Defense SPF 50+ recalled | Shiseido America | Processing Deviation | Nationwide |