Label: LIP CARE SPF 15 WITH VITAMIN E- octinoxate, 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 January 30, 2014

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  • WARNINGS AND PRECAUTIONS

    Drug Facts

  • Active Ingredient

    Octinoxate (7.5% w/w)

    Oxybenzone (5.0% w/w)

  • Purpose

    Sunscreen

    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 help prevent sunburn, skin cancer or early skin aging.

    • For external use only. 

    Don not use • on damaged or broken skin.

  • WHEN USING

    When using this product

    • keep out of eyes. Rinse with water to remove.

  • ASK DOCTOR

    Stop use and ask a doctor if

    • rash occurs.

  • PRECAUTIONS

    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. • reapply this product at least every 2 hours. • use water resistant sunscreen if swimming or sweating. • children under 6 months of age: ask a doctor.

  • Other information

    • protect the product in this container from excessive heat and direct sun.

  • Inactive Ingredients:

    Ricinus Communis (Castor) Seed Oil, Hydrogenated Coconut Oil, Olea Europaea (Olive) Fruit Oil, Beeswax, Euphorbia Cerifera (Candelilla) Wax, Cocos Nucifera (Coconut) Oil, Tocopheryl Acetate, Vanilla Planifolia Extract,Ammonium Glycyrrhizate, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Tocopherol, Glycine Soja (Soybean) Oil.

  • Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    LIP CARE SPF 15 WITH VITAMIN E 
    octinoxate, oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0336
    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) OXYBENZONE5.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    VANILLA (UNII: Q74T35078H)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ECHINACEA PURPUREA (UNII: QI7G114Y98)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorVANILLAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0336-14.2 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/20/2004
    Labeler - Autumn Harp, Inc. (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc.064187883manufacture(51514-0336)
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