Label: OHUI POWDERY METAL CUSHION COMPACT 01 LIGHT BEIGE- titanium dioxide powder

  • 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 16, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    ENSULIZOLE 2.7%, OCTINOXATE 7%, TITANIUM DIOXIDE 7.18%, ZINC OXIDE 2.91%

  • 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.

  • WARNINGS

    For external use only

    Do not use on damaged or broken skin.

    When using this product: Kepp out of the eyes. Rinse with water to remove.

    Stop use and ask doctor, if rash occurs.

    Keep out of reach of children. If product is swallowed, get medical help or

    contact a Posion 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, 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 a.m. to 2 p.m.

    - Wear longsleeved 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

    CYCLOPENTASILOXANE, WATER, METHYL TRIMETHICONE, DIPROPYLENE GLYCOL, PEG-10 DIMETHICONE, POLYMETHYL METHACRYLATE, NIACINAMIDE, TROMETHAMINE, 1,2-HEXANEDIOL, DISTEARDIMONIUM HECTORITE, STEARIC ACID, ALUMINUM HYDROXIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SODIUM CHLORIDE, SORBITAN SESQUIOLEATE, SORBITAN SESQUIISOSTEARATE, ZINC STEARATE, DISTEARYLDIMONIUM CHLORIDE, TOCOPHERYL ACETATE, PALMITOYL PROLINE, DIMETHICONE/METHICONE COPOLYMER, ADENOSINE, MAGNESIUM PALMITOYL GLUTAMATE, SODIUM PALMITOYL SARCOSINATE, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, BIOSACCHARIDE GUM-1, PALMITIC ACID, BUTYLENE GLYCOL, CETYL PEG/PPG-10/1 DIMETHICONE, HEXYL LAURATE, POLYGLYCERYL-4 ISOSTEARATE, ALBIZIA JULIBRISSIN BARK EXTRACT, FRAGRANCE, TITANIUM DIOXIDE(CI 77891), MICA, IRON OXIDES(CI 77492), IRON OXIDES(CI 77491), IRON OXIDES(CI 77499)

  • PRINCIPAL DISPLAY PANEL - 15 g Container 01 Light Beige

    OHUI Powdery Metal Cushion Compact

    Sunscreen Broad Spectrum SPF 50

    Net Wt. 1.05 oz / 30 g (15gx2)

    53208-602-01

  • INGREDIENTS AND APPEARANCE
    OHUI POWDERY METAL CUSHION COMPACT 01 LIGHT BEIGE 
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-602
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.077 g  in 15 g
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE0.405 g  in 15 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.05 g  in 15 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.436 g  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    WATER (UNII: 059QF0KO0R)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-602-012 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(53208-602)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZENISCE Co.Ltd.690188305manufacture(53208-602)