IM PURE CICA SUNSCREEN- zinc oxide, titanium dioxide lotion

IM PURE CICA SUNSCREEN by

Drug Labeling and Warnings

IM PURE CICA SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Normalest Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

IM PURE CICA SUNSCREEN 
zinc oxide, titanium dioxide lotion

Product 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)