IM PURE PERFECT CICA- zinc oxide, titanium dioxide 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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im pure perfect cica

Active Ingredients

Zinc Oxide, Titanium Dioxide

Inactive Ingredients

Water, Cyclopentasiloxane, Propanediol, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dibutyl Adipate, Caprylyl Methicone, 1,2-Hexanediol, Disteardimonium Hectorite, Magnesium Sulfate, Hydrogen Dimethicone, Aluminum Hydroxide, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Polyglyceryl-2 Dipolyhydroxystearate, Styrene/Acrylates Copolymer, Stearic Acid, Helianthus Annuus (Sunflower) Seed Oil, Pentylene Glycol, Butylene Glycol, Ethylhexylglycerin, Octyldodecanol, Centella Asiatica Extract, Galactomyces Ferment Filtrate, Anthemis Nobilis Flower Oil, Echium Plantagineum Seed Oil, Salvia Hispanica Seed Extract, Houttuynia Cordata Extract, Fructooligosaccharides, Saccharide Hydrolysate, Pullulan, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Madecassoside, Dicaprylyl Carbonate, Sorbitan Sesquioleate, Cyclomethicone, Undecane, Tridecane, Tocopherol, Dimethicone Crosspolymer, Phenyl Trimethicone

IM PURE PERFECT CICA 
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72284-0008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.82 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.56 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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)  
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
INVERT SUGAR (UNII: ED959S6ACY)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72284-0008-11 in 1 BOX04/24/2019
150 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 finalpart35204/24/2019
Labeler - Normalest Co., Ltd. (694812877)
Registrant - Normalest Co., Ltd. (694812877)
Establishment
NameAddressID/FEIBusiness Operations
Normalest Co., Ltd.694812877manufacture(72284-0008)

Revised: 4/2019
Document Id: 873c438a-031a-474e-e053-2991aa0ab92e
Set id: 873c438a-0319-474e-e053-2991aa0ab92e
Version: 1
Effective Time: 20190423
 
Normalest Co., Ltd.