JANE SEYMOUR NATURAL ADVANTAGE (OCTINOXATE, OXYBENZONE, AND OCTISALATE) CREAM [GUTHY-RENKER LLC]

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JANE SEYMOUR NATURAL ADVANTAGE (OCTINOXATE, OXYBENZONE, AND OCTISALATE) CREAM [GUTHY-RENKER LLC]
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NDC 11410-410-47, 11410-420-13
Set ID 74da8e40-eda8-4554-bacc-ffa464574510
Category HUMAN OTC DRUG LABEL
Packager Guthy-Renker LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • DIRECTIONS

    Apply to face every morning after cleansing.

  • WARNINGS

    For external use only.

    Avoid contact with eyes. If eye contact occurs, flush gently and thoroughly with water.

    Discontinue use if rash or irritation occurs.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • SUN ALERT

    Because this product may make your skin more sensitive to the sun, be certain you have adequate sunscreen protection while using this product and for a week after you discontinue use.

  • ACTIVE INGREDIENTS

    Octinoxate 7.5%, Oxybenzone 4.0%, Octisalate 3.5%

  • INACTIVE INGREDIENTS

    Water, Glycolic Acid, Glycerin, Steareth-20, PEG-100 Stearate, Hexyl Laurate, Dimethicone, Steareth-2, Cetyl Alcohol, DEA-Cetyl Phosphate, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Ammonium Hydroxide, Camellia Oleifera Leaf Extract, Ormenis Multicaulis Oil, Tocopheryl Acetate, Allantoin, Panthenol, Butylene Glycol, Propylene Glycol, Glyceryl Stearate, Octyldodecyl Neopentanoate, Stearic Acid, Bentonite, Xanthan Gum, Octyldodecanol, Disodium EDTA, Diazolidinyl Urea, Methylparaben, Propylparaben, Aluminum Hydroxide, (CI 77002), Titanium Dioxide (CI 77891)

  • PRINCIPAL DISPLAY PANEL - 25 ml Bottle Label

    NATURAL
    Advantage®
    JANE SEYMOUR

    AM
    SPF 15
    All Day Moisture
    with AHAs

    0.85 fl oz 25 ml e

    Principal Display Panel - 25 ml Bottle Label
  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

    NATURAL
    Advantage®
    JANE SEYMOUR

    AM
    SPF 15
    All Day Moisture
    with AHAs

    1.7 fl oz 50 ml e

    Principal Display Panel - 50 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    JANE SEYMOUR NATURAL ADVANTAGE   AM SPF 15 ALL DAY MOISTURE WITH AHAS
    octinoxate, oxybenzone, and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 mL  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.04 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.035 mL  in 1 mL
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11410-410-4725 mL in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35205/08/2008
    JANE SEYMOUR NATURAL ADVANTAGE   AM SPF 15 ALL DAY MOISTURE WITH AHAS
    octinoxate, oxybenzone, and octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-420
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 mL  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.04 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.035 mL  in 1 mL
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11410-420-1350 mL in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35205/08/2008
    Labeler - Guthy-Renker LLC (608315453)
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