SUNTIQUE IM PURE PERFECT CICA- titanium dioxide, zinc oxide lotion 
Normalest Co., Ltd.

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.

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SUNTIQUE I'M PURE PERFECT CICA
120 mL

SUNTIQUE I'M PURE PERFECT CICA

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)

Revised: 7/2020
Document Id: ab7baaca-469c-c872-e053-2a95a90a5509
Set id: ab7b934f-5ee7-9acb-e053-2a95a90a14b5
Version: 1
Effective Time: 20200728
 
Normalest Co., Ltd.