Label: SCAPE SPF 30 LIP BALM- avobenzone, octinoxate, octisalate,octocrylene, oxybenzone stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 April 27, 2011

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  • SPL UNCLASSIFIED SECTION

    FROM THE LAB OF DR. NIC MARTENS

    SCAPE

    LIP BALM SPF 30

  • ACTIVE INGREDIENT

    Active Ingredients

    Avobenzone 2.0%

    Octinoxate 7.5%

    Octisalate 5.0%

    Octocrylene 6.0%

    Oxybenzone 5.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Aloe Barbadensis Leaf Juice, Arachidyl Propionate, BHT, Cetyl Alcohol, Isopropyl Lanolate, Isopropyl Myristate, Lanolin, Methylparaben, Mineral Oil (Paraffinum Liquidum), Octyldodecanol, Ozokerite, Petrolatum, Phenyl Trimethicone, Propylparaben, Saccharin, Diisostearoyl Trimethylolpropane Siloxy Silicate, Stearic Acid, Tocopheryl Acetate, Copernicia Cenifer (Carnauba) Wax  (Cera Carnauba), Paraffin, Flavor.

  • INDICATIONS & USAGE

    Uses: Helps prevent sunburn. Helps prevent and temporarily protects chapped, cracked and wind burned lips due to dryness.
  • WARNINGS

    Warnings:  Discontinue use if irritation develops or increases. If irritation persists, consult a health care practitioner.
  • DOSAGE & ADMINISTRATION

    Directions: Apply prior to sun exposure.
  • SPL UNCLASSIFIED SECTION

    MANUFACTURED FOR:
    OUTSIDE LABS, INC.
    GARDENA, CA 90247
  • PRINCIPAL DISPLAY PANEL

    FROM THE LAB OF DR. NIC MARTENS

    SCAPE

    LIP BALM SPF 30

    UVA/UVB

    ALOE

    VITAMIN E

    SUNBURN PROTECTANT

    + MOISTURIZER


    NET WT: 0.15OZ (4.25 g) STICK

    Sealed For Your Protection
    Twist Cap To Break Seal

    ScapeStickA

    ScapeStickB

  • INGREDIENTS AND APPEARANCE
    SCAPE SPF 30 LIP BALM 
    avobenzone, octinoxate, octisalate,octocrylene, oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76174-140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LANOLIN (UNII: 7EV65EAW6H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SACCHARIN (UNII: FST467XS7D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76174-140-014.25 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/27/2011
    Labeler - Nupur Formulations Inc (246855006)