Label: AMAZONIC NATURAL SUNSCREEN SPF 30 BROAD SPECTRUM UVA/UVB- 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

    Sunburn Protection

  • Uses

    • Helps prevent sunburn.
    • If used as directed with other sun protection measure (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Directions

    • Apply liberally 15-minutes before sun exposure.
    • Reapply:
    • At least, every 2 hours.
    • I m mediately after swimming, sweating or towel drying.
    • 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:  SUN PROTECTION MEASURES:
    • Limit time in the sun, especially between 10 am and 2 pm.
    • Wear long sleeve shirts, pants, hats and sunglasses.
    • For children under 6-months, consult a physician.
  • 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.

  • Inactive Ingredients

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Daucus Carota Sativa (Carrot) Extract, Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lecithin, Henoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Theobroma Cacao (Cocoa) Butter, Tocopherol (Vitamin E,), Xanthan Gum.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    AMAZONIC NATURAL SUNSCREEN SPF 30 BROAD SPECTRUM UVA/UVB 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71522-834
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARROT (UNII: L56Z1JK48B)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    SESAME OIL (UNII: QX10HYY4QV)  
    COCOA (UNII: D9108TZ9KG)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71522-834-01118 g in 1 TUBE; Type 0: Not a Combination Product06/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/28/2017
    Labeler - Amazonic Products (965495703)
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