DR.ESLEE SUN MATTE (OCTINOXATE) LIQUID [AJOU MEDICS CO., LTD]

DR.ESLEE SUN MATTE (OCTINOXATE) LIQUID [AJOU MEDICS CO., LTD]
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NDC 76340-3001-1
Set ID a1cc4150-6d4f-4a14-ad98-e3eca5d476aa
Category HUMAN OTC DRUG LABEL
Packager Ajou Medics Co., Ltd
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    active ingredient: ethylhexyl methoxycinnamate

  • INACTIVE INGREDIENT

    inactive ingredient: Butylene Glycol, 4-Methylbenzylidene Camphor, Titanium Dioxide, Cetyl Alcohol, Octocrylene, Hydrogenated Polydecene, Polysorbate 80, Cyclomethicone, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate, Sorbitan Stearate, Polyhydroxystearic Acid, Aluminum Hydroxide, Triethanolamine, Carbomer, Xanthan Gum, Poncirus Trifoliata Fruit Extract, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate, Biosaccharide Gum-1, Tocopheryl Acetate, Disodium EDTA, Salicylic Acid, Farnesyl Acetate, Farnesol, Panthenyl, Triacetate, Hydrolyzed Algin, Zinc Sulfate, Phenoxyethanol, Methylparaben, Propylparaben, Butylparaben

  • PURPOSE

    helps protect from UV-Rays

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    ■ Apply Proper Amount of the cream on skin before sun exposure

  • WARNINGS

    ■ For external use only. Avoid contact with eyes.
    ■ Avoid contact with eyes.
    ■ Do not swallow. If swallowed, get medical help.
    ■ Keep out of reach of children.
    ■ Stop use and ask doctor if rash and irritation develops.

  • DOSAGE & ADMINISTRATION

    Reapply Frequently, every 2 hours for best result

  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    DR.ESLEE SUN MATTE 
    octinoxate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76340-3001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ENZACAMENE (UNII: 8I3XWY40L9)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    C12-16 ALCOHOLS (UNII: S4827SZE3L)  
    OCTOCRYLENE (UNII: 5A68WGF6WM)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    FARNESOL (UNII: EB41QIU6JL)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76340-3001-160 g in 1 TUBE; Type 0: Not a Combination Product01/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/10/2011
    Labeler - Ajou Medics Co., Ltd (688796473)
    Registrant - Ajou Medics Co., Ltd (688796473)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ajou Medics Co., Ltd688796473manufacture(76340-3001)

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