IM PURE CICA SUNSCREEN- 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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Active Ingredients

Zinc Oxide (11.6%)

Titanium Dioxide (3.1%)

Inactive Ingredients

Water, Cyclomethicone, Hydrogen Dimethicone, Aluminum Hydroxide, Stearic Acid, Dicaprylyl Carbonate, Propanediol, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethicone Crosspolymer, Phenyl Trimethicone, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, 1,2-Hexanediol, Saccharide Hydrolysate, Fructooligosaccharides, Pullulan, Cetyl Ethylhexanoate, Disteardimonium Hectorite, Magnesium Sulfate, Polyglyceryl-2 Dipolyhydroxystearate, Helianthus Annuus (Sunflower) Seed Oil, Anthemis Nobilis Flower Oil, Ethylhexylglycerin, Octyldodecanol, Echium Plantagineum Seed Oil, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Tocopherol, Galactomyces Ferment Filtrate, Butylene Glycol, Pentylene Glycol, Caprylyl Glycol, Madecassoside

IM PURE CICA SUNSCREEN 
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72284-0004
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
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
CARDIOSPERMUM HALICACABUM WHOLE (UNII: 185RQ97K0V)  
MADECASSOSIDE (UNII: CQ2F5O6YIY)  
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
INVERT SUGAR (UNII: ED959S6ACY)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)  
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
PROPANEDIOL (UNII: 5965N8W85T)  
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
SALVIA HISPANICA SEED (UNII: NU0OLX06F8)  
HOUTTUYNIA CORDATA WHOLE (UNII: O3E12ZLW5T)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FOSFRUCTOSE (UNII: M7522JYX1H)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72284-0004-11 in 1 BOX03/06/2019
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 finalpart35203/06/2019
Labeler - Normalest Co., Ltd. (694812877)
Registrant - Normalest Co., Ltd. (694812877)
Establishment
NameAddressID/FEIBusiness Operations
Normalest Co., Ltd.694812877manufacture(72284-0004)

Revised: 3/2019
Document Id: 83152174-d212-ab65-e053-2a91aa0a489f
Set id: 83152174-d211-ab65-e053-2a91aa0a489f
Version: 1
Effective Time: 20190306
 
Normalest Co., Ltd.