Label: IM PURE PERFECT CICA- zinc oxide, titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 72284-0008-1 - Packager: Normalest Co., Ltd.
- 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 April 23, 2019
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PRINCIPAL DISPLAY PANEL
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
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INGREDIENTS AND APPEARANCE
IM PURE PERFECT CICA
zinc oxide, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72284-0008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5.82 g in 50 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.56 g in 50 mL Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72284-0008-1 1 in 1 BOX 04/24/2019 1 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/24/2019 Labeler - Normalest Co., Ltd. (694812877) Registrant - Normalest Co., Ltd. (694812877) Establishment Name Address ID/FEI Business Operations Normalest Co., Ltd. 694812877 manufacture(72284-0008)