Label: SUNTIQUE IM PURE PERFECT CICA- titanium dioxide, zinc oxide lotion

  • 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 July 28, 2020

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  • PRINCIPAL DISPLAY PANEL

    SUNTIQUE I'M PURE PERFECT CICA

  • INGREDIENTS AND APPEARANCE
    SUNTIQUE IM PURE PERFECT CICA 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72284-0120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.744 g  in 120 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13.968 g  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    INVERT SUGAR (UNII: ED959S6ACY)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)  
    SALVIA HISPANICA SEED (UNII: NU0OLX06F8)  
    TRIDECANE (UNII: A3LZF0L939)  
    MADECASSOSIDE (UNII: CQ2F5O6YIY)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIBUTYL ADIPATE (UNII: F4K100DXP3)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    UNDECANE (UNII: JV0QT00NUE)  
    WATER (UNII: 059QF0KO0R)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72284-0120-11 in 1 BOX07/27/2020
    1120 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/27/2020
    Labeler - Normalest Co., Ltd. (694812877)
    Registrant - Normalest Co., Ltd. (694812877)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSON Co., Ltd._Osan Plant689847210manufacture(72284-0120)
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