Label: NARS AFTERGLOW LIP BALM CLEAN CUT- octinoxate 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 January 9, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octinoxate 7.4%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    Skin Cancer/Skin Aging Alert

    Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

    For external use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs

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

  • Directions　

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months: Ask a doctor
  • Inactive ingredients

    Hydrogenated Polyisobutene ∙ Triisostearin ∙ Squalane ∙ Bis-Diglyceryl Polyacyladipate-2 ∙ Diphenylsiloxy Phenyl Trimethicone ∙ Polyethylene ∙ Microcrystalline Wax ∙ Diisostearyl Malate ∙ Cocos Nucifera (Coconut) Oil ∙ Tocopherol ∙ Gardenia Taitensis Flower Extract ∙ Tocopheryl Acetate ∙ Simmondsia Chinensis (Jojoba) Seed Oil ∙ Punica Granatum Flower Extract ∙ Polysilicone-2 ∙ Glyceryl Diisostearate ∙ Simethicone ∙ Trimethylolpropane Triethylhexanoate ∙ Lauryl PCA ∙ Methicone ∙ Tetradecene ∙ Tin Oxide ∙ BHT ∙ Silica ∙ Aluminum Hydroxide ∙ Phenoxyethanol ∙ Titanium Dioxide ∙ Iron Oxides ∙ Red 7 Lake ∙

  • Other information

    • protect this product in this container from excessive heat and direct sun
  • Questions or comments?

    Call toll free 1-888-788-NARS

  • PRINCIPAL DISPLAY PANEL - 3 g Cartridge Carton

    NARS

    AFTERGLOW LIP BALM
    SPF 10 SUNSCREEN

    NET WT. 0.1 Oz. 3 g

    PRINCIPAL DISPLAY PANEL - 3 g Cartridge Carton
  • INGREDIENTS AND APPEARANCE
    NARS AFTERGLOW LIP BALM CLEAN CUT 
    octinoxate stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13734-160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE222 mg  in 3 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    TRIISOSTEARIN (UNII: 71503RH8KG)  
    SQUALANE (UNII: GW89575KF9)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    TRIMETHYLOLPROPANE TRIETHYLHEXANOATE (UNII: B952ZGW1IL)  
    LAURYL PIDOLATE (UNII: 29C5O2BJYA)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    JOJOBA OIL (UNII: 724GKU717M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    TETRADECENE (UNII: FW23481S7S)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13734-160-201 in 1 CARTON02/01/2019
    13 g in 1 CARTRIDGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35202/01/2019
    Labeler - NARS Cosmetics (837363571)
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