OHUI ULTIMATE COVER CC CUSHION COMPACT 01 LIGHT BEIGE (TITANIUM DIOXIDE) POWDER [LG HOUSEHOLD AND HEALTH CARE INC]

OHUI ULTIMATE COVER CC CUSHION COMPACT 01 LIGHT BEIGE (TITANIUM DIOXIDE) POWDER [LG HOUSEHOLD AND HEALTH CARE INC]
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NDC 53208-600-02
Set ID 29a1089b-8c62-63a4-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager LG Household and Health Care Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENTS

    ENSULIZOLE 2.7%, TITANIUM DIOXIDE 5.46%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun exposure.

  • Warnings

    For external use only. Do not use on damaged or broken skin. When using this product: Keep out of the 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. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regulary 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 a.m. to 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.

  • Other Information

    Protect this product from excessive heat and direct sun.

  • INACTIVE INGREDIENTS

    WATER, TRIETHYLHEXANOIN, DIMETHICONE, PHENYL TRIMETHICONE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, CYCLOPENTASILOXANE, DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS, CETYL PEG/PPG-10/1 DIMETHICONE, NIACINAMIDE, TROMETHAMINE, 1,2-HEXANEDIOL, SORBITAN SESQUIOLEATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SODIUM CHLORIDE, ZINC STEARATE, PEG-30 DIPOLYHYDROXYSTEARATE, DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, STEARIC ACID, DISTEARYLDIMONIUM CHLORIDE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, PALMITOYL PROLINE, PHENOXY ETHANOL, ADENOSINE, BIOSACCHARIDE GUM-1, TRIETHOXYCAPRYLYLSILANE, MAGNESIUM PALMITOYL GLUTAMATE, SODIUM PALMITOYL SARCOSINATE, PALMITIC ACID, DIPROPYLENE GLYCOL, LUFFA CYLINDRICA FRUIT EXTRACT, HEXYL LAURATE, SODIUM CITRATE, POLYGLYCERYL-4 ISOSTEARATE, TOCOPHEROL, FRAGRANCE, TITANIUM DIOXIDE(CI 77891), MICA, IRON OXIDES(CI 77492), IRON OXIDES(CI 77491), IRON OXIDES(CI 77499)

  • Principal Display Panel

    CC Cushion 01

  • INGREDIENTS AND APPEARANCE
    OHUI ULTIMATE COVER CC CUSHION COMPACT 01 LIGHT BEIGE 
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE0.405 g  in 15 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.819 g  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    WATER (UNII: 059QF0KO0R)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
    DIPENTAERYTHRITYL HEXA C5-9 ACID ESTERS (UNII: D818OLQ51Z)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    ADENOSINE (UNII: K72T3FS567)  
    SODIUM PALMITOYL SARCOSINATE (UNII: 7297LY09YF)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    LUFFA AEGYPTIACA FRUIT (UNII: QKL9NEO1F9)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MAGNESIUM PALMITOYL GLUTAMATE (UNII: DH37YM1F48)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    PALMITOYL PROLINE (UNII: I49727TDYF)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-600-023 in 1 CARTON01/25/2016
    115 g in 1 CONTAINER; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/25/2016
    Labeler - LG Household and Health Care Inc (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    LG Household and Health Care Inc688276187manufacture(53208-600)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZENISCE Co.Ltd690188305manufacture(53208-600)

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