DR.JART CICAPAIR TIGER GRASS COLOR CORRECTING TREATMENT (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [HAVE & BE CO., LTD.]

DR.JART CICAPAIR TIGER GRASS COLOR CORRECTING TREATMENT (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [HAVE & BE CO., LTD.]
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NDC 49404-140-01, 49404-140-02, 49404-140-03, 49404-140-04
Set ID e9a38ac6-147e-4a63-9061-a8b445a0503f
Category HUMAN OTC DRUG LABEL
Packager Have & Be Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Zinc Oxide 5.76%

    Titanium Dioxide 4.72%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Helps prevent sunburn

    If used as directed with other sun protection meausres (see Directions), decreases the risk of skin cancer and early skin aging casued by the sun

  • DOSAGE & ADMINISTRATION

    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours.
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: 

    – Limit time in the sun, especially from 10 am - 2 pm

    – Wear long-sleeved shirts, pants, hats and
    sunglasses

    • Children under 6 months: Ask a doctor

  • WARNINGS

    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 using and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

  • INACTIVE INGREDIENT

    WATER, CENTELLA ASIATICA LEAF WATER, ISONONYL ISONONANOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ISOTRIDECYL ISONONANOATE, METHYLPROPANEDIOL, BIS-HYDROXYETHOXYPROPYL DIMETHICONE, METHYL METHACRYLATE CROSSPOLYMER, BUTYLOCTYL SALICYLATE, POLYGLYCERYL-4DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, BEESWAX, LAURYL POLYGLYCERYL-3POLYDIMETHYLSILOXYETHYL DIMETHICONE, GLYCERIN, NIACINAMIDE, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, POLYMETHYLSILSESQUIOXANE, IRON OXIDES(CI 77492), TRIETHOXYCAPRYLYLSILANE, CAPRYLYL GLYCOL, CHROMIUM OXIDE GREENS, SYNTHETIC FLUORPHLOGOPITE, IRON OXIDES(CI 77491), GLYCERYL CAPRYLATE, ZEIN, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ETHYLHEXYLGLYCERIN, CITRUS PARADISI (GRAPEFRUIT) PEEL OIL, SILICA DIMETHYL SILYLATE, ROSMARINUS OFFICINALIS (ROSEMARY) LEAFOIL, ALUMINUM HYDROXIDE, ADENOSINE, ZEA MAYS (CORN) STARCH, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HYDROGENATED LECITHIN, ANTHEMIS NOBILIS FLOWER OIL, TOCOPHEROL, DIPOTASSIUM PHOSPHATE, MADECASSOSIDE, SODIUM CHLORIDE, CALCIUM STEARATE, BUTYLENE GLYCOL, PANTHENOL , HOUTTUYNIA CORDATA EXTRACT , ANIBA ROSODORA (ROSEWOOD) WOOD OIL, GOSSYPIUM HERBACEUM (COTTON) EXTRACT, ALCOHOL , CENTELLA ASIATICA MERISTEM CELL CULTURE, ANASTATICA HIEROCHUNTICA EXTRACT, 1,2-HEXANEDIOL, PENTYLENE GLYCOL, MAGNESIUM ASPARTATE, ZINC GLUCONATE, ARNICA MONTANA FLOWER EXTRACT, LECITHIN, BRASSICA CAMPESTRIS (RAPESEED) STEROLS, GENTIANA LUTEA ROOT EXTRACT, ACHILLEA MILLEFOLIUM EXTRACT, ARTEMISIA ABSINTHIUM EXTRACT, LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE, SUCROSE LAURATE, POLYGLYCERYL-2 CAPRATE, CENTELLA ASIATICA EXTRACT, FRAGARIA VESCA (STRAWBERRY) FRUIT EXTRACT, PHENOXYETHANOL, GLUCONOLACTONE, LYSOLECITHIN, CERAMIDE NP, COPPER GLUCONATE, SODIUM BENZOATE, SODIUM ASCORBYL PHOSPHATE, XANTHAN GUM, POTASSIUM SORBATE, DISODIUM EDTA, MADECASSIC ACID, ASIATICOSIDE, ASIATIC ACID

  • OTHER SAFETY INFORMATION

    Protect the product in this container from excessive heat and direct sunlight

    You may report a serious adverse event from use of this product to: Report Reaction, LLC PO Box 22 Plainsboro, NJ 08536-0222

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DR.JART CICAPAIR TIGER GRASS COLOR CORRECTING TREATMENT 
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49404-140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.36 mg  in 50 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.88 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHROMIC OXIDE (UNII: X5Z09SU859)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    ZEIN (UNII: 80N308T1NN)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ADENOSINE (UNII: K72T3FS567)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49404-140-021 in 1 CARTON05/02/2018
    1NDC:49404-140-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:49404-140-041 in 1 PACKAGE05/02/2018
    2NDC:49404-140-0315 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/02/2018
    Labeler - Have & Be Co., Ltd. (690400408)
    Registrant - Have & Be Co., Ltd. (690400408)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689512611manufacture(49404-140)

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