Label: O HUI PERFECT SUN BLACK EX BROAD SPECTRUM SPF 50- ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide cream

  • 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 June 1, 2017

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  • ACTIVE INGREDIENTS

    ENSULIZOLE 3.5%, OCTINOXATE 7.0%, OCTISALATE 4.5%, TITANIUM DIOXIDE 4.4%, ZINC OXIDE 9.71%

  • PURPOSE

    Sunscreen

  • USES

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), may decrease 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: Keep 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 othersun 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 the product in this container from excessive heat and direct sun.

    INACTIVE INGREDIENTS

    WATER, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, GLYCERIN, DICAPRYLYL CARBONATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TROMETHAMINE, DIMETHICONE, PANTHENOL, CHRYSIN, GALANTHUS NIVALIS SEED EXTRACT, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, STEARIC ACID, ZINC STEARATE, SORBITAN SESQUIOLEATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, GLYCERYL CAPRYLATE, HYDROGEN DIMETHICONE, DISTEARYLDIMONIUM CHLORIDE, ETHYLHEXYLGLYCERIN, TRISODIUM EDTA, TRIETHOXYCAPRYLYLSILANE, DIPHENYLSILOXY PHENYL TRIMETHICONE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), FRAGRANCE

  • PRINCIPAL DISPLAY PANEL

    O HUI Perfect Sun Black EX

    Sunscreen Broad Spectrum SPF 50+

    1.69 fl oz / 50 ml

    box

  • INGREDIENTS AND APPEARANCE
    O HUI PERFECT SUN BLACK EX BROAD SPECTRUM SPF 50 
    ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-604
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.2 g  in 50 g
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE1.75 g  in 50 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 g  in 50 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.25 g  in 50 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.86 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    WATER (UNII: 059QF0KO0R)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    CHRYSIN (UNII: 3CN01F5ZJ5)  
    HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GALANTHUS NIVALIS SEED (UNII: SJ1FOL985M)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    DISTEARYLDIMONIUM (UNII: 251IW5I21C)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-604-011 in 1 CARTON06/01/2017
    150 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 finalpart35206/01/2017
    Labeler - LG Household and Health Care Inc (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    LG Household and Health Care Inc688276187manufacture(53208-604)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZENISCE Co.Ltd.690188305manufacture(53208-604)
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