DR.ESLEE SUN PROTECTION (OCTINOXATE) CREAM [AJOU MEDICS CO., LTD]

DR.ESLEE SUN PROTECTION (OCTINOXATE) CREAM [AJOU MEDICS CO., LTD]
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NDC 76340-0004-1
Set ID 672012ea-87f2-6da5-e053-2991aa0ac322
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: Water, Propylene Glycol, Cyclopentasiloxane, Ethylhexyl Salicylate, Zinc Oxide,
    Cyclohexasiloxane, Titanium Dioxide, Cetyl PEG/PPG-10/1 Dimethicone, Hydrogenated Poly(C6-14 Olefin), Betaine, Isoamyl p-Methoxycinnamate, Dimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Methyl Methacrylate Crosspolymer, Silica, imethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Tocopheryl Acetate, Houttuynia Cordata Extract, Allantoin, Hydrolyzed Collagen, Biosaccharide Gum-1, Portulaca Oleracea Extract, Phenoxyethanol, Methylparaben , Propylparaben, Butylparaben, Fragrance

  • PURPOSE

    helps to 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 the skin before sun exposure

  • WARNINGS

    ■ For external use only.
    ■ 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

    apply frequently every 2 hours for best result

  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    DR.ESLEE SUN PROTECTION 
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76340-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BETAINE (UNII: 3SCV180C9W)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    METHYL METHACRYLATE (UNII: 196OC77688)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALGELDRATE (UNII: 03J11K103C)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    ALLANTOIN (UNII: 344S277G0Z)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    PURSLANE (UNII: M6S840WXG5)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76340-0004-160 g in 1 TUBE; Type 0: Not a Combination Product03/11/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/11/2018
    Labeler - Ajou Medics Co., Ltd (688796473)
    Registrant - Ajou Medics Co., Ltd (688796473)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ajou Medics Co., Ltd688796473manufacture(76340-0004)

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