OSEQUE HIGH END TOUCH WATERFIT COVER CUSHION (PINK BEIGE)- titanium dioxide octinoxate octisalate amiloxate cream

OSEQUE HIGH END TOUCH WATERFIT Cover Cushion (Pink Beige) by

Drug Labeling and Warnings

OSEQUE HIGH END TOUCH WATERFIT Cover Cushion (Pink 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 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, Rosa Damascena Flower Water, Betula Alba Juice, Hydrolyzed Hyaluronic Acid, Silica, Mesembryantheum Crystalinum Extract, Fullerenes, Saccharomyces Ferment Filtrate, Camellia Japonica Seed Oil, Tocopheryl Acetate, 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

Uses: Apply liberally over the face and body 15 minutes prior to sun exposure.  Always ensure total coverage of all sun exposed areas.  Re-apply every 1-2 hours and always after swimming.  For spray type, shake it well before use and spray it evenly at 20cm-30cm apart from face or wherever needed.

STORAGE AND HANDLING

Storage: Keep in a dry or room temperature area

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OSEQUE HIGH END TOUCH WATERFIT COVER CUSHION (PINK BEIGE) 
titanium dioxide octinoxate octisalate amiloxate cream

Product Information
Product Type	COSMETIC	Item Code (Source)	59370-310
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)
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
BETULA PENDULA BARK (UNII: 40S83Y133C)
HYALURONIC ACID (UNII: S270N0TRQY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MESEMBRYANTHEMUM CRYSTALLINUM WHOLE (UNII: KFD19SXO43)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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	59370-310-01	15 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/09/2017

Labeler - SONGHAK CO., LTD. (688237512)

Registrant - SONGHAK CO., LTD. (688237512)

Establishment
Name	Address	ID/FEI	Business Operations
SONGHAK CO., LTD.		688237512	manufacture(59370-310)