Label: LIP RASPBERRY SPF30- zinc oxide 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 April 18, 2018

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  • Drug Facts

  • Active Ingredient

    Zinc Oxide 8.55%

  • 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 the 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 a doctor if rash occurs.

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

  • Do not use

    on damaged or broken skin

  • Stop use and ask doctor

    if rash occurs

  • When using this product

    keep out of eyes, rinse with water to remove.

  • Keep out of reach of children

    If swallowed, get medical help or contact Poison Center right away.

  • Directions

    * Apply liberally 15 minutes before sun exposure.

    * Reapply:

    - After 80 minutes of swimming or sweating.

    - Immediately after towel drying.

    - At least every 2 hours.

    * Children under 6 months of age: Ask a doctor.

    * Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    - Limit time in sun, especially from 10a.m. to 2p.m.

    - Wear long-sleeved shirts, pants, hats and sunglasses.

  • Other Information

    * Protect this product from excessive heat and direct sun.

    * Store at temperatures below 90'F.

    * May Stain some fabrics or surfaces.

  • Inactive Ingredients

    Bisabolol, Butyrospermum Parkii (Shea Butter)*, Calophyllum Inophyllum (Tamanu) Oil*, Capric/Caprylic Triglyceride (Fractionated Coconut Oil), Cocos Nucifera (Coconut) Oil*, Copernicia Cerifera (Carnauba) Wax*, Euphorbia Cerifera (Candelilla) Wax, Natural Flavor, Olea Europaea (Olive) Oil*, Pongamia Glabra (Karanja) Seed Oil*, Schinziophyton Rautanenii (Mongongo) Kernel Oil*, Stearic Acid, Stevia Rebaudiana Leaf/Stem Extract, Theobroma Cacao (Cocoa) Seed Butter*, Theobroma Grandiflorum (Cupuacu) Butter*, Tocopherol

    *Organic

  • Questions or Comments

    Toll-free 1-855-SAFE-SUN or www.goddessgarden.com

  • Product Label

    Raspberry

  • INGREDIENTS AND APPEARANCE
    LIP RASPBERRY  SPF30
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58479-640
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE8.55 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SCHINZIOPHYTON RAUTANENII SEED OIL (UNII: 6GSJ7A6T1E)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    TAMANU OIL (UNII: JT3LVK84A1)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    KARUM SEED OIL (UNII: 62160PU6FJ)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58479-640-044 g in 1 TUBE; Type 0: Not a Combination Product02/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2018
    Labeler - Crossing Cultures LLC dba Goddess Garden (078444606)
    Registrant - Crossing Cultures LLC dba Goddess Garden (078444606)
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