Label: YESTO POMEGRANATE LIP BUTTER WITH SPF 15- zinc oxide 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 September 19, 2013

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  • Active Ingredient

    Zinc Oxide (7.6%)

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by sun.

  • Warnings

    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 Doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact 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.

    Sun Protection Measure

    Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2pm. Wear long sleeved shirts, pants, hats and sun-glasses. 

  • Inactive Ingredients

    Beeswax, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Helianthus Annuus (Sunflower) Seed Oil, Flavor, Glycine Soja (Soybean) Oil, Copernicia Cerifera (Carnauba) Wax, Jojoba Esters, Butyrospermum Parkii (Shea Butter)*, Ammonium Glycyrrhizate, Tocopherol (Vitamin E), Aloe Barbadensis Leaf Extract*, Limonene, Linalool. * Certified Organic Ingredient

  • Other Information

    Protect this product from excessive heat and direct sun

  • Principal Display Panel

    Image Components

    image description

    Principal Display Panel

    Image Components

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  • INGREDIENTS AND APPEARANCE
    YESTO POMEGRANATE LIP BUTTER WITH SPF 15 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0307
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) Zinc Oxide7.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE WAX (UNII: 7G1J5DA97F)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    DECYL JOJOBATE (UNII: ZL61O8TFZU)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    CITRAL (UNII: T7EU0O9VPP)  
    EUGENOL (UNII: 3T8H1794QW)  
    GERANIOL (UNII: L837108USY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPOMEGRANATEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0307-14.2 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/01/2013
    Labeler - Autumn Harp, Inc. (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc.064187883manufacture(51514-0307)
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