Label: DR.ESLEE SUN PROTECTION- octinoxate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 17, 2018

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

  • 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)