CALIFORNIA NATUREL LIP BALM SPF 8 (TITANIUM DIOXIDE AND ZINC OXIDE) LIPSTICK [CALIFORNIA NATUREL]

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CALIFORNIA NATUREL LIP BALM SPF 8 (TITANIUM DIOXIDE AND ZINC OXIDE) LIPSTICK [CALIFORNIA NATUREL]
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NDC 61547-101-11, 61547-101-51
Set ID ab072d5e-2a09-41b1-b416-f961da842705
Category HUMAN OTC DRUG LABEL
Packager CALIFORNIA NATUREL
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    TITANIUM DIOXIDE 1.8%

    ZINC OXIDE 2%

  • PURPOSE

    PURPOSE

    SUNSCREEN

  • INDICATIONS & USAGE

    USES

    • HELPS PROTECT AGAINST SUNBURN AND CHAPPED LIPS
  • WARNINGS

    WARNINGS

    SKIN CANCER/SKIN AGING ALERT: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING; DO NOT USE ON DAMAGED OR BROKEN SKIN; STOP USE AND ASK A DOCTOR IF RASH OCCURS

  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • APPLY LIBERALLY BEFORE SUN EXPOSURE AND AS NEEDED
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS

    ACTINIDIA CHINENSIS (KIWI) OIL, C12-15 ALKYL BENZOATE, BUTYLOCTYL SALICYLATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, CAPRYLIC/CAPRIC TRIGLYCERIDE, COPERNICIA CERIFERA (CARNAUBA) WAX, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, BEESWAX (CERA ALBA), ETHYLHEXYL STEARATE, FLAVOR (AROMA), FRAGARIA VESCA (STRAWBERRY) FRUIT EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, ISOSTEARIC ACID, LANOLIN, OLEA EUROPAEA (OLIVE) FRUIT OIL, POLYHYDROXYSTEARIC ACID, PUNICA GRANATUM EXTRACT, RICINUS COMMUNIS SEED OIL, SUCRALOSE, TOCOPHERYL ACETATE (VITAMIN E ACETATE), VACCINIUM ANGUSTIFOLIUM (BLUEBERRY) EXTRACT, VACCINIUM MACROCARPON (CRANBERRY) FRUIT EXTRACT

  • PRINCIPAL DISPLAY PANEL

    140124-Outline-NOUVEAU_Dessin technique_LIPBALM Converti

  • INGREDIENTS AND APPEARANCE
    CALIFORNIA NATUREL LIP BALM  SPF 8
    titanium dioxide and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61547-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.8 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    KIWI SEED OIL (UNII: O70FWV3WPP)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYLOCTYL BENZOATE (UNII: 28ON9X7M1L)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    STRAWBERRY JUICE (UNII: U8NS58UGW0)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LANOLIN (UNII: 7EV65EAW6H)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PUNICA GRANATUM WHOLE (UNII: O2ZTS50U5E)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LOWBUSH BLUEBERRY JUICE (UNII: 834067J0NY)  
    CRANBERRY JUICE (UNII: Y74M3X3345)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61547-101-511 in 1 BOX
    1NDC:61547-101-114.2 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/14/2014
    Labeler - CALIFORNIA NATUREL (079115834)
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