Label: FOR THE GARDENER LIP BALM- octinoxate, octocrylene, octisalate, and oxybenzone stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 16, 2011

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  • Active ingredients

    Octinoxate 7.5%, Octocrylene 7.0%, Octisalate 5.0%, Oxybenzone 5.0%

  • Purposes

    Sunscreens

  • Use

    • helps prevent sunburn
  • Warnings

    • Stop use if skin rash occurs
  • Inactive ingredients

    petrolatum, isopropyl myristate, paraffin, candelilla wax, synthetic beeswax, polyethylene, cetyl alcohol, lanolin, isopropyl lanolate, oleyl alcohol, octyldodecanol, phenyl trimethicone, flavor, tocopheryl acetate, aloe barbadensis leaf extract, glycine soja (soybean) oil, titanium dioxide, methylparaben, propylparaben, silica, saccharin, DEA-oleth-3-phosphate

  • Other information

    You may report serious adverse reaction to this product to: Ganz U.S.A., LLC #043, 60 Industrial Parkway, Cheektowaga, New York, 14227-9903

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED FOR:
    GANZ, Cheektowaga, N.Y. 14227-9903

  • PRINCIPAL DISPLAY PANEL - 4 g Carton

    time & again®

    LIP BALM

    SPF 30
    ALOE & VITAMIN E

    UVA/UVB SUNSCREEN PROTECTION

    Principal Display Panel - 4 g Carton
  • INGREDIENTS AND APPEARANCE
    FOR THE GARDENER LIP BALM   SPF 30
    octinoxate, octocrylene, octisalate, and oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75862-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LANOLIN (UNII: 7EV65EAW6H)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHARIN (UNII: FST467XS7D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75862-018-501 in 1 BOX
    14 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35208/10/2011
    Labeler - GANZ U.S.A., LLC (798785242)
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