RASPBERRY LIP SPF30 (ZINC OXIDE) STICK [CROSSING CULTURES LLC DBA GODDESS GARDEN]

RASPBERRY LIP SPF30 (ZINC OXIDE) STICK [CROSSING CULTURES LLC DBA GODDESS GARDEN]
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NDC 58479-052-04
Set ID 6a132cfe-a606-61a1-e053-2991aa0ac53f
Category HUMAN OTC DRUG LABEL
Packager Crossing Cultures LLC dba Goddess Garden
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts

  • Active Ingredient

    Zinc Oxide 5.7%

  • 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 and 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)*, Caprylic/Capric Triglyceride (Coconut Oil), Cocos Nucifera (Coconut) Oil*, Copernicia Cerifera (Carnauba) Wax*, Euphorbia Cerifera (Candelilla) Wax, Flavor (Natural Raspberry Flavor), Jojoba Esters, Olea Europaea (Olive) Fruit Oil*, Oryzanol, Schinziophyton Rautanenii (Mongongo) Kernel Oil*, Stevia Rebaudiana Extract, Theobroma Cacao (Cocoa) Seed Butter*, Theobroma Grandiflorum (Cupuassu) Seed Butter, Tocopherol (Vitamin E)

    *Certified Organic

  • Questions or Comments

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

    Dist. by: Goddess Garden, Boulder, CO 80301 ©2017

  • Product Label

    Raspberry

  • INGREDIENTS AND APPEARANCE
    RASPBERRY LIP  SPF30
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58479-052
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    GAMMA ORYZANOL (UNII: SST9XCL51M)  
    SCHINZIOPHYTON RAUTANENII SEED OIL (UNII: 6GSJ7A6T1E)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58479-052-044 g in 1 TUBE; Type 0: Not a Combination Product01/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2017
    Labeler - Crossing Cultures LLC dba Goddess Garden (078444606)
    Registrant - Crossing Cultures LLC dba Goddess Garden (078444606)

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