GAP FAVORITE LIP BALM APPLE PIE SPF 18 (OCTINOXATE AND OXYBENZONE) STICK [AUTUMN HARP, INC]

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GAP FAVORITE LIP BALM APPLE PIE SPF 18 (OCTINOXATE AND OXYBENZONE) STICK [AUTUMN HARP, INC]
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NDC 51514-0227-1
Set ID ec0d5b8f-3b5e-4a20-8dbf-8465e9acf2fb
Category HUMAN OTC DRUG LABEL
Packager Autumn Harp, Inc
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active Ingredient

    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

    • apply liberally before sun exposure and as needed
    • children under 6 months: 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

    Enter section text here

  • label

    R03748 label

  • INGREDIENTS AND APPEARANCE
    GAP FAVORITE LIP BALM  APPLE PIE SPF 18
    octinoxate and oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0227
    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
    FlavorAPPLEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0227-14 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/08/2011
    Labeler - Autumn Harp, Inc (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc064187883manufacture
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