Label: GAP FAVORITE LIP BALM CITRUS SPLASH SPF 18- octinoxate 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 November 16, 2011

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  • Active Ingredients

    Active Ingredients                Purpose

    Octinoxate 7.5%                  Sunscreen

    Oxybenzone 6%                  Sunscreen

  • Purpose

    • lip moisturizer
    • helps prevent sunburn
    • higher SPF gives more sunburn protection
  • Warning

    Warnings

    For external use only

  • When using this product

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

  • Stop use

    Stop use and ask a doctor if rash and irritation develops and lasts

  • Keep out of reach of children

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

  • Directions

    Directions

    • apply liberally before sun exposure and as needed
    • children under 6 months of age: ask doctor
  • Sun Alert

    Other information

    Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin cancer, and other harmful effects of the sun.

  • Inactive Ingredients

    Inactive Ingredients:  Hydrogenated Coconut Oil, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Olea Europaea (Olive) Fruit Oil, Flavor, Tocopheryl Acetate, Ammonium Glycyrrhizate, Glycine Soja (Soybean) Oil, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Tocopherol, Lecithin, Rosmarinus Officinalis (Rosemary) Leaf Extract.

  • PRINCIPAL DISPLAY PANEL

    Image of labelGAP Citrus Splash

  • INGREDIENTS AND APPEARANCE
    GAP FAVORITE LIP BALM  CITRUS SPLASH SPF 18
    octinoxate and oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0212
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ROSEMARY (UNII: IJ67X351P9)  
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEFRUIT (Grapefruit Lime) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0212-14 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/16/2011
    Labeler - Autumn Harp, Inc (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc064187883manufacture
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