Label: IM PURE CICA SUNSCREEN- zinc oxide, titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 72284-0004-1 - 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 March 6, 2019
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PRINCIPAL DISPLAY PANEL
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
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INGREDIENTS AND APPEARANCE
IM PURE CICA SUNSCREEN
zinc oxide, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72284-0004 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 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 Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72284-0004-1 1 in 1 BOX 03/06/2019 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 03/06/2019 Labeler - Normalest Co., Ltd. (694812877) Registrant - Normalest Co., Ltd. (694812877) Establishment Name Address ID/FEI Business Operations Normalest Co., Ltd. 694812877 manufacture(72284-0004)