Label: JURLIQUE PURELY SUN-DEFYING- zinc oxide and titanium dioxide cream, augmented

  • Category: HUMAN OTC DRUG LABEL

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 September 13, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Zinc Oxide, 4.8%
    Titanium Dioxide, 2.1%    		bracket imageSunscreen
  • Use

    • helps prevent sunburn
  • Warnings

    Skin Cancer/Skin Aging Alert

    Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

    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.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months: Ask a doctor
  • Other information

    • protect this product from excessive heat and direct sun
    • you may report a serious adverse reaction to Report Reaction, LLC PO Box 22, Plainsboro, NJ 08536-022
  • Inactive ingredients

    Water, Simmondsia chinensis (Jojoba) Seed Oil, Glyceryl Stearate Citrate, Glycerin, Caprylic/Capric Triglyceride, Macadamia integrifolia Seed Oil, Mauritia flexuosa Fruit Oil, Sorbitan Palmitate, Glyceryl Isostearate, Porphyra umbilicalis Extract, Ectoin, Sambucus nigra (Black Elder) Flower Extract, Viola tricolor (Pansy) Extract, Viola odorata (Sweet Violet) Extract, Glycyrrhiza glabra (Licorice) Root Extract, Rosa gallica Flower Extract, Chamomilla recutita (Matricaria) Flower Extract, Althaea officinalis (Marshmallow) Root Extract, Polyhydroxystearic Acid, Lecithin, Sodium Lactate, Aluminum Hydroxide, Hydrated Silica, Alginic Acid, Beta-Glucan, Sodium Hyaluronate, Hydrolyzed Wheat Protein/PVP Crosspolymer, Xanthan Gum, Sodium Phytate, Bisabolol, SD Alcohol 40-A, Phenoxyethanol, Ethylhexylglycerin, Chlorphenesin, Totarol, Citrus medica limonum (Lemon) Peel Oil, Lavandula angustifolia (Lavender) Oil, Pelargonium graveolens Flower Oil, Fusanus spicatus Wood Oil, Citrus aurantium dulcis (Orange) Flower Oil, Anthemis nobilis Flower Extract, Pogostemon cablin Oil, Jasminum officinale (Jasmine) Flower Extract, Canarium luzonicum Gum Nonvolatiles.

  • PRINCIPAL DISPLAY PANEL - 40g Tube Carton

    Jurlique

    Purely Sun-Defying

    Moisturizer with
    SPF 15 Sunscreen

    A high performance
    protective cream

    e 40g Net wt. 1.4 oz.

    Principal Display Panel - 40g Tube Carton
  • INGREDIENTS AND APPEARANCE
    JURLIQUE PURELY SUN-DEFYING   MOISTURIZER WITH SPF 15 SUNSCREEN
    zinc oxide and titanium dioxide cream, augmented
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68105-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.8 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
    SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    ALGINIC ACID (UNII: 8C3Z4148WZ)  
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)  
    VIOLA TRICOLOR (UNII: 9Q24RAI43V)  
    VIOLA ODORATA (UNII: AET12U8B74)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    ROSA GALLICA FLOWER (UNII: X8W61WUV70)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ECTOINE (UNII: 7GXZ3858RY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    LEMON OIL (UNII: I9GRO824LL)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)  
    CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    PATCHOULI OIL (UNII: F3IN55X5PO)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    ELEMI (UNII: C13XI009KO)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68105-004-0140 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/01/2011
    Labeler - Jurlique International Pty. Ltd. (752025791)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Laboratories of America617165329MANUFACTURE
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