Label: JOSIE MARAN MOISTURE REPAIR FACIAL BARRIER- colloidal oatmeal 1% cream

  • NDC Code(s): 54111-163-50
  • Packager: Bentley Laboratories, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 23, 2022

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  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredient
    Colloidal Oatmeal 1.0%

  • PURPOSE

    Purpose

    Skin protectant

  • INDICATIONS & USAGE

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

  • WARNINGS

    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

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

  • DOSAGE & ADMINISTRATION

    Directions apply as needed.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Aloe Barbadensis Leaf Juice**, Caprylic/Capric
    Triglyceride**, Argania Spinosa Kernel Oil*, Glycerin, Butyrospermum
    Parkii (Shea) Butter**, Glyceryl Stearate, Behenyl Alcohol**, Hydrogenated
    Vegetable Glycerides**, Squalane**, Glyceryl Behenate**, Myristyl
    Myristate**, Stearyl Alcohol**, Octyldodecyl PCA, Phenoxyethanol,
    Ethylhexylglycerin, Alpha-Glucan Oligosaccharide**, Sodium Stearoyl
    Glutamate**, Helianthus Annuus (Sunflower) Seed Extract**, Argan Oil
    Aminopropanediol Esters**, Xanthan Gum**, Bisabolol, Phytosterols**,
    Withania Somnifera (Ashwagandha) Root Extract**, Hordeum vulgare
    Extract**, Helianthus Annuus (Sunflower) Seed Oil**, Cucumis Sativus
    (Cucumber) Fruit Extract**, Cucumis Sativus (Cucumber) Seed Oil**


    *Organic ** Naturally Derived

  • OTHER SAFETY INFORMATION

    Other information
    • Store at room temperature.

  • QUESTIONS

    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

    MOISTURE REPAIR FACIAL BARRIER CREAM

    Net Wt. 50g 1.7 oz.

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

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  • INGREDIENTS AND APPEARANCE
    JOSIE MARAN MOISTURE REPAIR FACIAL BARRIER 
    colloidal oatmeal 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-163
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10.0 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    C14-18 MONO-AND DI-GLYCERIDES (UNII: 82TZ9D9546)  
    SQUALANE (UNII: GW89575KF9)  
    GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    OCTYLDODECYL PCA (UNII: E25TY46YTD)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    ARGAN OIL AMINOPROPANEDIOL ESTERS (UNII: 2HA4BS9RJJ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)  
    HORDEUM VULGARE WHOLE (UNII: 8JBE478M5Q)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CUCUMBER (UNII: YY7C30VXJT)  
    CUCUMBER SEED OIL (UNII: AKP926H71P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54111-163-501 in 1 CARTON03/09/2022
    150 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/09/2022
    Labeler - Bentley Laboratories, LLC (068351753)
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