OSEQUE HIGH END TOUCH WATERFIT COVER CUSHION NATURAL BEIGE- titanium dioxide octinoxate octisalate cream

OSEQUE HIGH END TOUCH WATERFIT COVER CUSHION Natural Beige by

Drug Labeling and Warnings

OSEQUE HIGH END TOUCH WATERFIT COVER CUSHION Natural Beige by is a Other medication manufactured, distributed, or labeled by SONGHAK CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Titanium Dioxide (CI 77891) 8.3%, Ethylhexyl Methoxycinnamate 7%, Ethylhexyl Salicylate 3%, Isoamyl p-Methoxycinnamate 3%, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine 1.5%, Niacinnamide 2%

PURPOSE

Purpose: Skin Protectant

INTENDED USE OF THE DEVICE

Uses: Helps prevent sunburn

INACTIVE INGREDIENT

Inactive Ingredients: Water, Butylene Glycol, Cyclopentasiloxane, Phenyl Trimethicone, Cyclohexasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, C12-15 Alkyl Benzoate, SD Alcohol 40-B, Dimethicone, Dicaprylyl Carbonate, Iron Oxides (CI 77492), Trimethylsiloxysilicate, Sorbitan Sesquioleate, Phenoxyethanol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Dimethicone/Vinyl Dimethicone Crosspolymer, Beeswas, Disteardimonium Hectorite, Polypropylsilsesquioxane, Polyhydroxystearic Acid, Iron Oxides (CI 77491), 1,2-Hexanediol, Iron Oxides (CI 77499), Fragrance (Parfum), Propylene Carbonate, Lecithin, Ethylhexyl Palmitate, Isostearic Acid, Isopropyl Palmitate, Dimethiconol, Caprylhydroxamic Acid, Adenosine, Polyglyceryl-3 Polyricinoleate, Triethoxycaprylylsilane, Disodium EDTA, Sodium Chloride, Royal Jelly Extract, Pullulan, Betula Alba Juice, Hydrolyzed Hyaluronic Acid, Silica, Mesembryantheum Crystalinum Extract, Silkworm Cocoon Extract, Ceramide NP, Glycine, Tocopherol Glutamic Acid, Lysine, Leucine, Methionine, Valine, Serine, Cysteine, Aspartic Acid, Alanine, Arginine, Isoleucine, Tyrosine, Threonine, Phenylalanine, Proline, Histidine

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately

WARNINGS

Warnings: For external use only.  Not to be swallowed.  Avoid contact with eyes.  Discontinue use if signs of irritation or rash appear

INSTRUCTIONS FOR USE

Directions: Use after removing the film lid.  Apply with the puff by tapping.

STORAGE AND HANDLING

Storage: Keep in a dry cool place away from the direct sunlight.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OSEQUE HIGH END TOUCH WATERFIT COVER CUSHION NATURAL BEIGE 
titanium dioxide octinoxate octisalate cream

Product Information
Product Type	COSMETIC	Item Code (Source)	59370-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.245 g  in 15 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.05 g  in 15 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.45 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
AMILOXATE (UNII: 376KTP06K8)
BEMOTRIZINOL (UNII: PWZ1720CBH)
NIACINAMIDE (UNII: 25X51I8RD4)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
SORBITAN OLIVATE (UNII: MDL271E3GR)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WHITE WAX (UNII: 7G1J5DA97F)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
FERRIC OXIDE RED (UNII: 1K09F3G675)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISOSTEARIC ACID (UNII: X33R8U0062)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
ADENOSINE (UNII: K72T3FS567)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ROYAL JELLY (UNII: L497I37F0C)
PULLULAN (UNII: 8ZQ0AYU1TT)
BETULA PUBESCENS RESIN (UNII: 9G931M6I4G)
HYALURONIC ACID (UNII: S270N0TRQY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MESEMBRYANTHEMUM CRYSTALLINUM WHOLE (UNII: KFD19SXO43)
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)
CERAMIDE NP (UNII: 4370DF050B)
GLYCINE (UNII: TE7660XO1C)
TOCOPHEROL (UNII: R0ZB2556P8)
GLUTAMIC ACID (UNII: 3KX376GY7L)
LYSINE (UNII: K3Z4F929H6)
LEUCINE (UNII: GMW67QNF9C)
METHIONINE (UNII: AE28F7PNPL)
VALINE (UNII: HG18B9YRS7)
SERINE (UNII: 452VLY9402)
CYSTEINE (UNII: K848JZ4886)
ASPARTIC ACID (UNII: 30KYC7MIAI)
ALANINE (UNII: OF5P57N2ZX)
ARGININE (UNII: 94ZLA3W45F)
ISOLEUCINE (UNII: 04Y7590D77)
TYROSINE (UNII: 42HK56048U)
THREONINE (UNII: 2ZD004190S)
PHENYLALANINE (UNII: 47E5O17Y3R)
PROLINE (UNII: 9DLQ4CIU6V)
HISTIDINE (UNII: 4QD397987E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	59370-300-01	15 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/24/2017

Labeler - SONGHAK CO., LTD. (688237512)

Registrant - SONGHAK CO., LTD. (688237512)

Establishment
Name	Address	ID/FEI	Business Operations
SONGHAK CO., LTD.		688237512	manufacture(59370-300)