Label: PRO TRIPLE PROTECTION FACTOR LIP BALM BROAD SPECTRUM SPF 30 SUNSCREEN- octinoxate, octisalate, avobenzone, zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 February 1, 2017

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  • SPL UNCLASSIFIED SECTION

    Triple Protection Factor Lip Balm provides ultimate lip protection with SPF 30, DNA Enzyme Complex™ + Antioxidants.

    Unique lip balm that nourishes and conditions, creating smooth, healthy-looking lips.

  • Use Directions:

    Apply generously and evenly to lips prior to sun exposure.

    Reapply frequently to maintain protection.

  • IMPORTANT:

    DO NOT STAY TOO LONG IN THE SUN, EVEN WHILE USING A SUNSCREEN PRODUCT. KEEP BABIES AND YOUNG CHILDREN OUT OF DIRECT SUNLIGHT. OVEREXPOSURE TO THE SUN IS A SERIOUS, HEALTH THREAT.

  • Store at room temperature.

    Clinically and Dermatologist Tested

    • Non-Comedogenic
    • Fragrance Free
    • Paraben Free
  • INGREDIENTS:

    PETROLATUM, BEESWAX/CERA ALBA/CIRE D'ABEILLE, MICROCRYSTALLINE WAX/CERA MICROCRISTALLINA/CIRE MICROCRISTALLINE, BUTYROSPERMUM PARKII (SHEA) BUTTER, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE, RICINUS COMMUNIS (CASTOR) SEED OIL, POLYBUTENE, BUTYL METHOXYDIBENZOYLMETHANE, NYLON-12, GLYCERETH-26, BUTYLOCTYL SALICYLATE, DIOCTYLDODECYL DODECANEDIOATE, ZINC OXIDE, C12-15 ALKYL BENZOATE, LANOLIN, SQUALANE, ACETYL FARNESYLCYSTEINE, ARABIDOPSIS THALIANA EXTRACT, ASTROCARYUM MURUMURU SEED BUTTER, BISABOLOL, CARNOSINE, COPERNICIA CERIFERA (CARNAUBA) WAX/CERA CARNAUBA/CIRE DE CARNAUBA, ERGOTHIONEINE, ETHYLHEXYLGLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HONEY EXTRACT, HYDROGENATED CASTOR OIL, LECITHIN, LINOLEIC ACID, LINOLENIC ACID, MICROCOCCUS LYSATE, PLANKTON EXTRACT, RETINYL PALMITATE, RICINOLETH-40, TOCOPHEROL, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, WATER/AQUA/EAU, BHT, PHENOXYETHANOL.

    Elizabeth Arden, London

    Made in U.S.A.

    Distributed by: Beauty Partner

    Enterprise, S.r.l., Rome, 00144, IT

  • Principal Display Panel - Bottle Label

    ElizabethArden

    PRO

    TRIPLE
    PROTECTION
    FACTOR
    LIP BALM

    Broad Spectrum
    SPF 30 Sunscreen

    HIGH PROTECTION
    Cream

    UVA

    14.ge

    Principal Display Panel - Bottle Label
  • Principal Display Panel - Carton Label

    ElizabethArden

    PRO

    TRIPLE
    PROTECTION
    FACTOR
    LIP BALM

    Broad Spectrum
    SPF 30 Sunscreen

    HIGH PROTECTION
    Cream

    UVA

    14.ge

    Principal Display Panel - Carton Label
  • INGREDIENTS AND APPEARANCE
    PRO TRIPLE PROTECTION FACTOR LIP BALM BROAD SPECTRUM SPF 30 SUNSCREEN 
    octinoxate, octisalate, avobenzone, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-2082
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.065 g  in 14.2 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE.71 g  in 14.2 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE.426 g  in 14.2 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE.142 g  in 14.2 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    NYLON-12 (UNII: 446U8J075B)  
    DIOCTYLDODECYL DODECANEDIOATE (UNII: 7QDB5EE79Y)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SQUALANE (UNII: GW89575KF9)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    LANOLIN (UNII: 7EV65EAW6H)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    RICINOLETH-40 (UNII: 6S0J4W9IQY)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    ACETYL FARNESYLCYSTEINE (UNII: KK6984C8O3)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    LINOLENIC ACID (UNII: 0RBV727H71)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
    HONEY (UNII: Y9H1V576FH)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67938-2082-11 in 1 BOX02/01/2017
    1NDC:67938-2082-214.2 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2017
    Labeler - ELIZABETH ARDEN, INC (849222187)
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