JOSIE MARAN Intensive Daily Repair Body Butter

Intensive Daily Repair Body Butter by

Drug Labeling and Warnings

Intensive Daily Repair Body Butter by is a Otc medication manufactured, distributed, or labeled by Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INTENSIVE DAILY REPAIR BODY BUTTER- colloidal oatmeal cream 
Bentley Laboratories, LLC

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JOSIE MARAN Intensive Daily Repair Body Butter

Drug Facts

Active Ingredient
Colloidal Oatmeal 0.8%

Purpose

Skin protectant

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

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.

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

Directions apply as needed.

Inactive Ingredients: Aloe Barbadensis Leaf Juice**, Caprylic/Capric Triglyceride**, Butyrospermum
Parkii (Shea) Butter**, Argania Spinosa Kernel Oil*, Glyceryl Stearate**, Stearyl Alcohol**, 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 information
Store at room temperature.

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

Product Package

JOSIE MARAN

ARGAN APOTHECARY

Intensive Daily Repair Body Butter
Eczema Relief with Argan Oil + Colloidal Oatmeal

Net Wt. 170g 6 oz.

FULL OF NATURALLY-DERIVED AND ORGANIC INGREDIENTS

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

170g Jar

65g Jar

res

INTENSIVE DAILY REPAIR BODY BUTTER 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-154
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	8 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SHEA BUTTER (UNII: K49155WL9Y)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SQUALANE (UNII: GW89575KF9)
WATER (UNII: 059QF0KO0R)
LEVOMENOL (UNII: 24WE03BX2T)
OCTYLDODECYL BEHENATE (UNII: BZM9WE5P6F)
XYMENYNIC ACID (UNII: IA0Z48P13W)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54111-154-50	1 in 1 CARTON	06/11/2021
1		170 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 54111-154-52	1 in 1 CARTON	05/12/2022
2		56 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/11/2021	12/01/2024

Labeler - Bentley Laboratories, LLC (068351753)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	manufacture(54111-154)

Revised: 12/2024

Document Id: 4aa0caeb-65fc-41a7-b941-0370fd139175

34390-5

Set id: c92d9043-f4d2-4382-aa66-8655b0c49f15

Version: 5

Effective Time: 20241228