FDA.reportPublic FDA data

JOSIE MARAN OTC ECZEMA BODY BUTTER -Vanilla and Chamomile

Manufacturer
Bentley Laboratories, LLC
Effective date
2023-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:17:33

Label at a glance#

ProductJOSIE MARAN OTC ECZEMA BODY BUTTER -Vanilla and Chamomile
Active ingredientOATMEAL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredient
Colloidal Oatmeal 0.8%

OTC - PURPOSE SECTION

Purpose

Skin protectant

INDICATIONS & USAGE SECTION

Uses
• temporarily protects and helps relieve minor skin irritation and itching due to eczema

WARNINGS SECTION

Warnings

For external use only.

When using this product
• do not get into eyes.

Stop use and ask a doctor if
• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days..

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

Directions apply as needed.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Aloe Barbadensis Leaf Juice**, Caprylic/Capric Triglyceride**, Argania Spinosa
Kernel Oil**, Butyrospermum Parkii (Shea) Butter**, Glyceryl Stearate**, Stearyl Alcohol**, Fragrance**,
Glycerin**, Alpha-Glucan Oligosaccharide**, Diisopropyl Adipate, Glyceryl Behenate**, Sodium Stearoyl
Glutamate**, Squalane**, Water/Aqua/Eau**, Bisabolol**, Octyldodecyl PCA**, Xymenynic Acid, Citric
Acid**, Ethylhexylglycerin, Phenoxyethanol.
*ORGANIC **NATURALLY DERIVED

OTHER SAFETY INFORMATION

Other information
• Store at room temperature.

OTC - QUESTIONS SECTION

Questions or comments?Call us at (888) 215-8733
or visit us at www.josiemaran.com Monday to Friday 6am-6pm PST

Product Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

JOSIE MARAN

ARGAN APOTHECARY

INTENSIVE DAILY REPAIR BODY BUTTER
Eczema Relief with Argan Oil + Colloidal Oatmeal

Vanilla and Chamomile

Net Wt. 170 g 6 oz.

Dist. by Josie Maran Cosmetics, LLC
Hollywood, CA 90038
josiemaran.com

@josiemaran

Carton Label

164-50 Crtn164-50 Crtn

Jar Label

164-50 Jar164-50 Jar

res

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54111-16454111-164-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YACTIB
ALOE VERA LEAFZY81Z83H0XIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ARGAN OIL4V59G5UW9XIACT
SHEA BUTTERK49155WL9YIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
STEARYL ALCOHOL2KR89I4H1YIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-GLUCAN OLIGOSACCHARIDES95658MI3WIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
GLYCERYL MONOBEHENATEA626UU0W2AIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
SQUALANEGW89575KF9IACT
WATER059QF0KO0RIACT
LEVOMENOL24WE03BX2TIACT
OCTYLDODECYL PCAE25TY46YTDIACT
XYMENYNIC ACIDIA0Z48P13WIACT
CITRIC ACID ACETATEDSO12WL7AUIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5e2ddbac-8834-4d03-aea4-d64080c13797084fbea2-3ce7-4035-a112-cf7712eeda702024-12-28WarningsExact identifier
spl set id: 084fbea2-3ce7-4035-a112-cf7712eeda70

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.