BABY NATURAL MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 (ZINC OXIDE) LOTION [CROSSING CULTURES LLC DBA GODDESS GARDEN]

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BABY NATURAL MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 (ZINC OXIDE) LOTION [CROSSING CULTURES LLC DBA GODDESS GARDEN]
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NDC 58479-033-00, 58479-033-01, 58479-033-02
Set ID 6efd81cd-8061-4444-9fa2-296bfd7972e9
Category HUMAN OTC DRUG LABEL
Packager Crossing Cultures LLC dba Goddess Garden
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts

  • Active Ingredients

    Zinc Oxide 19.0%

    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.

    Stop use and ask a 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 a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure. • Reapply: • After 40 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 the sun, especially from 10am to 2pm. • 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

    Aloe Barbadensis Leaf Juice*, Caprylhydroxamic Acid, Carthamus Tinctorius (Safflower) Seed Oil*, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Helianthus Annuus (Sunflower) Seed Oil*, Polyhydroxystearic Acid, Sorbitan Oleate, Tocopherol (Vitamin E), Water, Xanthan Gum *Certified Organic

  • Questions or Comments

    Toll-free 1-855-SAFE-SUN or

    www.GoddessGarden.com

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    BABY NATURAL MINERAL SUNSCREEN BROAD SPECTRUM  SPF 30
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58479-033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58479-033-0028 g in 1 TUBE; Type 0: Not a Combination Product01/18/2016
    2NDC:58479-033-0196 g in 1 TUBE; Type 0: Not a Combination Product01/18/2016
    3NDC:58479-033-026 g in 1 PACKET; Type 0: Not a Combination Product01/18/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/15/2016
    Labeler - Crossing Cultures LLC dba Goddess Garden (078444606)
    Registrant - Crossing Cultures LLC dba Goddess Garden (078444606)
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