Label: JUNGLE SCREEN SPF 30- titanium dioxide, zinc oxide lotion

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

Drug Label Information

Updated November 10, 2023

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  • Jungle Screen SPF 30


    Active Ingredients

    Titanium Dioxide  6.00% Zinc Oxide  6.00%

    Purpose

    Sunscreen

  • USES:

    Helps prevent sunburn.

  • 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. Immediately after swimming, sweating or towel drying. For children under 6 months, consult a physician.

  • SUN PROTECTION MEASURES:

    Spending time in the sun increases your risk of skin cancer and early sun 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: Limit time in the sun, especially between 10am and 2pm. Wear long sleeve shirts, pants, hats and sunglasses.

  • OTHER INGREDIENTS:

    Algae Extract, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Beeswax, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Leaf Extract, Cetearyl Olivate, Citrulllus Lanatus (Watermelon) Fruit Extract, Cocos Nucifera (Coconut) Oil, Glitter (Polyethylene Tetraphthalate, Polymethyl Methacrylate, Polyurethane-33, FD and C Yellow # 5, D and C Red #7), Cymbopogon Flexuosus (Lemongrass) Oil, Cymbopogon Nardus (Citronella) Oil, Ethyl Vanillin, Gluconolactone, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Lecithin, Mentha Piperita (Peppermint) Oil, Niacin, Octyl Palmitate, Petrolatum, Polysorbate-20, Simmondsia Chinensis (Jojoba) Leaf Oil, Sodium Benzoate, Sorbitan Olivate, Thuja Occidentalis (Cedar) Leaf Oil, Tocopheryl Acetate (Vitamin-E), Vitis Vinifera (Grape) Seed Extract, Xanthan Gum.

  • QUESTIONS OR COMMENTS?

    Contact us directly at www.glittertots.com GlitterTots LLC. Fort Lauderdale, FL 33348.

  • Jungle Screen SPF 30 3oz/90ml (65121-494-03)

    Jungle Screen

  • INGREDIENTS AND APPEARANCE
    JUNGLE SCREEN SPF 30 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-494
    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 OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SIMMONDSIA CHINENSIS LEAF (UNII: 67G221EK95)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CEDAR LEAF OIL (UNII: BJ169U4NLG)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    WATERMELON (UNII: 231473QB6R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65121-494-031 in 1 CARTON02/10/2017
    190 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/21/2014
    Labeler - Pure Source, LLC (080354456)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(65121-494)
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