EIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]

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EIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 (OCTINOXATE AND AVOBENZONE) SALVE [ELIZABETH ARDEN, INC]
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NDC 67938-1111-1, 67938-1111-2
Set ID a6271ee2-39c2-445a-bb24-f87745ac69be
Category HUMAN OTC DRUG LABEL
Packager Elizabeth Arden, Inc
Generic Name
Product Class
Product Number
Application Number PART352
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  • DESCRIPTION

    This daily moisturizing treatment replenishes lips with eight essential vitamins, nutrients and

    minerals while providing advanced broad spectrum SPF 20 sun protection against damaging

    UVA/UVB rays.

  • INDICATIONS AND USAGE

    To use: Squeeze tube and apply liberally with self-applicator tip.

  • WARNINGS

    WARNING

    :

    FOR EXTERNAL USE ONLY. DO NOT USE

    ON DAMAGED OR BROKEN SKIN. WHEN USING

    THIS PRODUCT KEEP OUT OF EYES. RINSE WITH

    WATER TO REMOVE. STOP USE AND ASK A

    DOCTOR IF RASH OCCURS. KEEP OUT OF REACH

    OF CHILDREN. IF PRODUCT IS SWALLOWED, GET

    MEDICAL HELP OR CONTACT A POISON CONTROL

    CENTER RIGHT AWAY.

     

  • OTC - ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: OCTINOXATE, 4.0 % W/W

    AVOBENZONE, 3.0 % W/W

  • INACTIVE INGREDIENT

    Inactive Ingredients

    POLYBUTENE, MICROCRYSTALLINE WAX/CERA

    MICROCRISTALLINA/CIRE MICROCRISTALLINE,

    PETROLATUM, RICINUS COMMUNIS (CASTOR)

    SEED OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER,

    NYLON-12, DIOCTYLDODECYL DODECANEDIOATE, C12-15

    ALKYL BENZOATE, GLYCERETH-26, BUTYLOCTYL

    SALICYLATE, LANOLIN, ASTROCARYUM MURUMURU

    SEED BUTTER, BEESWAX/CERA ALBA/CIRE D'ABEILLE,

    COPERNICIA CERIFERA (CARNAUBA) WAX/CERA

    CARNAUBA/CIRE DE CARNAUBA, HELIANTHUS ANNUUS

    (SUNFLOWER) SEED OIL, HONEY EXTRACT,

    HYDROGENATED CASTOR OIL, LINOLEIC ACID, LINOLENIC

    ACID, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT,

    RETINYL PALMITATE, TOCOPHEROL, TOCOPHERYL

    ACETATE, BHT, IRON OXIDES (CI 77491, CI 77492).

  • DOSAGE & ADMINISTRATION

    apply liberally

  • OTC - KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.
  • OTC - PURPOSE

    Provides SPF 20 sun protection.

  • OTC - WHEN USING

    KEEP OUT OF EYES.

  • PRINCIPAL DISPLAY PANEL

    EHCNLB - CARTON
    EHCNLB - insert
    EHCNLB - onsert
    EHCNLB - tube
  • INGREDIENTS AND APPEARANCE
    EIGHT HOUR CREAM NOURISHING LIP BALM SPF 20 
    octinoxate and avobenzone salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.568 g  in 14.2 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.426 g  in 14.2 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    NYLON-12 (UNII: 446U8J075B)  
    DIOCTYLDODECYL DODECANEDIOATE (UNII: 7QDB5EE79Y)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    LANOLIN (UNII: 7EV65EAW6H)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    LINOLENIC ACID (UNII: 0RBV727H71)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-1111-11 in 1 BOX
    1NDC:67938-1111-214.2 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/24/2012
    Labeler - Elizabeth Arden, Inc (849222187)
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