RAW ELEMENTS ECO FORMULA 30 BROAD SPECTRUM SPF 30 (ZINC OXIDE) CREAM [RAW ELEMENTS LLC]

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RAW ELEMENTS ECO FORMULA 30 BROAD SPECTRUM SPF 30 (ZINC OXIDE) CREAM [RAW ELEMENTS LLC]
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NDC 70680-300-01, 70680-300-02
Set ID 1d130543-9e12-42f4-80b4-915dbe0f85d4
Category HUMAN OTC DRUG LABEL
Packager Raw Elements LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts

  • Active Ingredients

    Zinc oxide 23%

    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 product is swallowed, get medical helps or contact a Poison Control 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

    • 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 of 15 or higher and other sun protection measures including:

      • limit time in the sun especially from 10 a.m. - 2 p.m.
      • wear long-sleeve shirts, pants, hats, and sunglasses

    • children under 6 months: Ask a doctor

  • Inactive ingredients

    Camellia Sinensis Leaf Extract (Organic Green Tea), Camellia Sinensis Leaf Extract (Organic Black Tea), Cannabis Sativa Seed Oil (Organic Hemp Seed Oil), Cera Alba (Organic Beeswax), Coffea Arabica Seed Extract (Organic Coffee Bean), Helianthus Annuus Seed Oil (Organic Sunflower Oil), Mangifera Indica Seed Butter (Natural Mango Butter), Rosmarinus Officinalis Leaf Oil (Natural Rosemary), Theobroma Cacao Seed Butter (Organic Cocoa Butter), Tocopherol

  • Other information

    • pretect this product from excessive heat and direct sun

  • Questions or comments?

    Call toll free 1-888-442-6676

  • Package Labeling:

    LabelRaw

  • INGREDIENTS AND APPEARANCE
    RAW ELEMENTS ECO FORMULA 30 BROAD SPECTRUM SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70680-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION230 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70680-300-0188 mL in 1 CONTAINER; Type 0: Not a Combination Product05/02/2016
    2NDC:70680-300-0288 mL in 1 TUBE; Type 0: Not a Combination Product05/02/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/02/2016
    Labeler - Raw Elements LLC (023973143)
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