Label: KOA PROTECT OUR OCEAN LIFE OXYBENZONE FREE BROAD SPECTRUM SPF 30 UVA UVB PROTECTION SUNSCREEN- titanium dioxide, zinc oxide cream

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

Drug Label Information

Updated November 11, 2023

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  • DRUG FACTS

  • Active Ingredients

    Titanium Dioxide (6.00%)

    Zinc Oxide (6.00%)

    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 consult physician 

    if irritation or rash develops. 

    Keep out of reach of children.

    If product is swallowed, get medical attention or contact poison control center immediately

  • DIRECTIONS:

    Apply liberally 15-minutes before sun exposure. Reapply at least every two-hours or immediately after swimming. sweating or towel drying. SUN PROTECTION MEASURES, Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: - Wear long sleeve shirts, pants, hats and sunglasses. - For children under 6-months, consult a physician.

  • OTHER INGREDIENTS

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cocos Nucifera (Coconut) Oil, Dehydroxanthan Gum, Gluconolactone, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lecithin, Mangifera Indica (Mango) Seed Butter. Sodium Benzoate, Sodium Laurylglucosides Hydroxypropyl Sulfonate, Styrene/Acrylates Copolymer, Tocopherol Acetate (Vitamin E), Xanthan Gum.

  • Other Information:

    Protect this product from excessive heat and direct sunlight

  • Package Labeling:

    Label5

  • INGREDIENTS AND APPEARANCE
    KOA PROTECT OUR OCEAN LIFE OXYBENZONE FREE BROAD SPECTRUM SPF 30 UVA UVB PROTECTION SUNSCREEN 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71889-350
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71889-350-081 in 1 CARTON11/18/2017
    1236 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/18/2017
    Labeler - Kapa'ihi, Inc (080938084)
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