Label: ULTRA REPAIR- shea butter cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 22, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: SHEA BUTTER 4.0%

  • INACTIVE INGREDIENT

    Inactive ingredients: Aqua (WATER), CAPRYLIC/CAPRIC TRIGLYCERIDE, ISOHEXADECANE, PEG-8 BEESWAX, MARIS AQUA (SEA WATER), MACADAMIA INTEGRIFOLIA SEED OIL, CETYL ALCOHOL, POLYACRYLAMIDE, PROPYLENE GLYCOL DIPELARGONATE, PHENOXYETHANOL, GLYCERYL STEARATE, PROPANEDIOL, C13-14 ISOPARAFFIN, HYDROXYACETOPHENONE, THEOBROMA GRANDIFLORUM SEED BUTTER, PROPYLENE GLYCOL, CETETH-20, TOCOPHERYL ACETATE, STEARETH-20, CENTELLA ASIATICA EXTRACT, LAURETH-7, GLYCERIN, PARFUM (FRAGRANCE), TOCOPHEROL, NYMPHAEA ALBA FLOWER EXTRACT, POTASSIUM SORBATE, CITRIC ACID, TROPOLONE, GARDENIA TAHITENSIS FLOWER EXTRACT, CUCURBITA PEPO (PUMPKIN) SEED EXTRACT, SODIUM HYDROXIDE, SODIUM BENZOATE

  • PURPOSE

    Purpose: Moisturizing and soothing sensitized skin

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indications & Usage: Apply morning and night

  • WARNINGS

    Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear.

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Apply morning and night to face and neck after serum and ampoule

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ULTRA REPAIR 
    shea butter cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71276-090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y) SHEA BUTTER2.4 g  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71276-090-021 in 1 CARTON03/02/2017
    1NDC:71276-090-0160 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/02/2017
    Labeler - ULAB (688976692)
    Registrant - ULAB (688976692)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULAB688976692relabel(71276-090)
    Establishment
    NameAddressID/FEIBusiness Operations
    U-LAB Switzerland AG485958743manufacture(71276-090)
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