Label: CARIBBEAN SOL NATURAL SUNSCREEN SPF-30- zinc oxide solution

  • NDC Code(s): 82520-264-00
  • Packager: Caribbean Sol International, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2023

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  • Drug Facts

  • Active Ingredient

    Zinc Oxide 16%

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions
  • 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 ocuurs

    Keep out of Reach of children.

    If product is swallowed, get medical help or contact a Poison Control center right away.

    If pregnant or breast-feeding,

    ask a health professional before use.

  • Directions-------SHAKE WELL--------

    • apply liberally 15 minutes before sun exposure
    • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • 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 SPE of 15 or higher and other sun protection measures including: Sun Protection Measures -
    • 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:

    Adansonia Digitata (Baobab) Oil, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, cetearyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Decyl Glucoside, Dodecane, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Hydroxyethylcellu-lose, Laminaria (Algae) Extract, Mangifera Indica (Mango) Butter, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Extract, Tocopherol (Vitamin E), Tridecyl Salicylate, Xanthan Gum.

  • Other information

    protect this product from excessive heat and direct sun

    Claims:

    • Mineral Ingredients
    • No Animal Testing
    • Gluten Free
    • No Parabens
  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    CARIBBEAN SOL NATURAL SUNSCREEN SPF-30 
    zinc oxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82520-264
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION160 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCONUT (UNII: 3RT3536DHY)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CARROT (UNII: L56Z1JK48B)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DODECANE (UNII: 11A386X1QH)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    MANGO (UNII: I629I3NR86)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82520-264-00177.44 mL in 1 CAN; Type 0: Not a Combination Product01/24/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/24/2022
    Labeler - Caribbean Sol International, LLC (116857302)
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