Label: RAW ELEMENTS ECO FORMULA SPF30 SAMPLE PACKS- zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 8, 2023

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  • Drug Facts

  • Active Ingredients

    Zinc Oxide 23%

    Purpose

    Sunscreen

  • Uses:

    Helps prevent sunburn

  • Warnings:

    For external use only.

    Do not use 

    on damaged or broken skin.

    Stop use and ask a doctor 

    if skin 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 80 minutes of swimming or sweating, Immediately after towel drying, at least every 2 hours. Children under 6 months: 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 10 a.m.-2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses.

  • Inactive Ingredients:

    Camellia Sinensis Leaf Extract (Organic Green Tea), Camellia Sinensis Leaf Extract (Organaic 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), Iron Oxides, Mangifera Indica Seed Butter (Natural Mango Butter), Rosmarinus Officinalis Leaf Oil (Natural Rosemary, Theobroma Cacao Seed Butter (Organic Cocoa Butter), Tocopherol
    *Certified Organic

  • Other Information:

    Protect this product from excessive heat and direct sun.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    RAW ELEMENTS ECO FORMULA SPF30 SAMPLE PACKS 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70680-308
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION230 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70680-308-004 g in 1 PACKET; Type 0: Not a Combination Product08/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/16/2019
    Labeler - Raw Elements LLC (023973143)
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