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

  • Category: COSMETIC
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

Drug Label Information

Updated January 25, 2017

If you are a consumer or patient please visit this version.

  • 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

    Box Label

  • INGREDIENTS AND APPEARANCE
    OSEQUE HIGH END TOUCH WATERFIT COVER CUSHION (PINK BEIGE) 
    titanium dioxide octinoxate octisalate amiloxate cream
    Product Information
    Product TypeCOSMETICItem Code (Source)59370-310
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.245 g  in 15 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.05 g  in 15 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.45 g  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    159370-310-0115 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/09/2017
    Labeler - SONGHAK CO., LTD. (688237512)
    Registrant - SONGHAK CO., LTD. (688237512)
    Establishment
    NameAddressID/FEIBusiness Operations
    SONGHAK CO., LTD.688237512manufacture(59370-310)