GREEN TEA ANTIOXIDANT BROAD SPECTRUM SPF 30 PAPLUSPLUSPLUS (OXYBENZONE, OCTISALATE, AND AVOBENZONE) LOTION [H2O PLUS LLC]

GREEN TEA ANTIOXIDANT BROAD SPECTRUM SPF 30 PAPLUSPLUSPLUS (OXYBENZONE, OCTISALATE, AND AVOBENZONE) LOTION [H2O PLUS LLC]
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NDC 65903-330-01
Set ID 920c26fe-dbae-478f-948e-d68bc90a4ef5
Category HUMAN OTC DRUG LABEL
Packager H2O Plus LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Oxybenzone 6.0%Sunscreen
    Octisalate 5.0%Sunscreen
    Avobenzone 3.0%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
  • Warnings

    • For external use only

    • Do not use on damaged or broken skin

    • Stop use and ask a doctor if 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

    • For Sunscreen use
    • Apply liberally 15 minutes before sun exposure
    • Use water resistance sunscreen if swimming or sweating
    • Reapply 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 broad spectrum SPF value of 15 or higher and other sun protection measures including:

    • Limit time in the sun especially from 10 am-2 pm
    • Wear long-sleeved shirts, pants, and sunglasses
  • Inactive Ingredients

    Aqua/Water/Eau, Ethylhexyl Isononanoate, Butylene Glycol, Glyceryl Stearate, C12-15 Alkyl Benzoate, Pentylene Glycol, Triisononanoin, Diethylhexyl 2,6-Naphthalate, Cera Alba/ Beeswax/Cire d'abeille, Sodium Dihydroxycetyl Phosphate, Polyglyceryl-3 Caprate, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Camellia Sinensis Leaf Extract, Faex/Yeast Extract/Extrait de levure, Fucus Vesiculosus Extract, Ilex Paraguariensis Leaf Extract, Panax Ginseng Root Extract, Tilia Cordata Wood Extract, Magnesium Ascorbyl Phosphate, Tocopherol, Biotin, Calcium Pantothenate, Carbomer, Citric Acid, Disodium EDTA, Glycerin, Glycogen, Hydrogenated Palm Glycerides, Hydrolyzed Wheat Protein, Lecithin, Mannitol, Maris Sal/Sea Salt/Sel Marin, Propylene Glycol, Thermus Thermophillus Ferment, Triethanolamine, Xanthan Gum, Chlorphenesin, Methylparaben, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate (090-00330-002)

  • Other information

    • Protect the product in this container from excessive heat and direct sun
  • SPL UNCLASSIFIED SECTION

    Distributed by:
    H2O Plus, L.L.C. Chicago, IL 60607

  • PRINCIPAL DISPLAY PANEL - 38 mL Bottle Carton

    h2o+®

    marine DEFENSE

    Anti-aging environmental
    protection

    GREEN TEA
    ANTIOXIDANT LOTION
    BROAD SPECTRUM
    SPF 30 PA+++

    Nourishes and protects
    against free-radical
    damage

    38 mL / 1.3 U.S. Fl oz e

    Principal Display Panel - 38 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    GREEN TEA ANTIOXIDANT BROAD SPECTRUM SPF 30 PAPLUSPLUSPLUS 
    oxybenzone, octisalate, and avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65903-330
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone60 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Triisononanoin (UNII: XF4K22WN6T)  
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Sodium Dihydroxycetyl Phosphate (UNII: YWI33EV595)  
    Tilia Cordata Wood (UNII: 674MYE89IE)  
    Horse Chestnut (UNII: 3C18L6RJAZ)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Yeast (UNII: 3NY3SM6B8U)  
    Fucus Vesiculosus (UNII: 535G2ABX9M)  
    Ilex Paraguariensis Leaf (UNII: 1Q953B4O4F)  
    Asian Ginseng (UNII: CUQ3A77YXI)  
    Magnesium Ascorbyl Phosphate (UNII: 0R822556M5)  
    Tocopherol (UNII: R0ZB2556P8)  
    Biotin (UNII: 6SO6U10H04)  
    Calcium Pantothenate (UNII: 568ET80C3D)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glycogen (UNII: 309GSC92U1)  
    Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Mannitol (UNII: 3OWL53L36A)  
    Sea Salt (UNII: 87GE52P74G)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)  
    Trolamine (UNII: 9O3K93S3TK)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65903-330-011 in 1 CARTON
    138 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35212/01/2014
    Labeler - H2O Plus LLC (807722947)

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