PURA VIDA SUNSCREEN (ZINC OXIDE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [R & R LOTION, INC]

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  • PURA VIDA SUNSCREEN (ZINC OXIDE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [R & R LOTION, INC]

PURA VIDA SUNSCREEN (ZINC OXIDE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [R & R LOTION, INC]
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NDC 59555-106-03, 59555-106-08, 59555-106-11
Set ID de1ae98f-8c32-49c5-a22a-c342243a2979
Category HUMAN OTC DRUG LABEL
Packager R & R Lotion, Inc
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Octinoxate 5.9%Sunscreen
    Octisalate 3.8%Sunscreen
    Oxybenzone 4.7%Sunscreen
    Zinc Oxide 6.4%Sunscreen
  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer & 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 ask a doctor if a rash occurs

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure reapply:
      • after 80 minutes of swimming or sweating
      • immediatly after towel drying
      • every 2 hours

    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 a broad spectrum SPF of 15 or higher and other sun protection measures including:

     
    • limit time in the sun, especially from 10am-2pm
    • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • Inactive Ingredients

    Purified DI Water, Octyl Stearate/Octyl Palmitate/Dioctyl Adipate, Propylene Glycol, Glyceryl Stearate & Peg 100, Cetearyl Alcohol & Ceteareth 20, Xanthan Gum, Imidazolidinyl Urea, Methyl Paraben, Propyl Paraben, Crodafos N3N, and Vitamin E.

  • Other Information

    • protect this product from excessive heat and direct sun
  • Questions or Comments?

    1-888-860-7424

  • PRINCIPAL DISPLAY PANEL - 236 ML Bottle Label

    for the
    Life
    of
    Your Skin

    Pura
    Vida

    Sunscreen
    SPF 30+
    protector solar

    Zinc Oxide

    BROAD SPECTRUM
    80 MINUTE WATER RESISTANCE

    8 FL. OZ. (236ML) e

    PRINCIPAL DISPLAY PANEL - 236 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    PURA VIDA SUNSCREEN 
    zinc oxide, octinoxate, octisalate, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide64 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate59 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate38 mg  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone47 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Diethylhexyl Adipate (UNII: MBY1SL921L)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Ethylhexyl Stearate (UNII: EG3PA2K3K5)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    .Alpha.-Tocopherol (UNII: H4N855PNZ1)  
    Imidurea (UNII: M629807ATL)  
    Diethanolamine Oleth-3 Phosphate (UNII: Y67NX5905E)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Peg-100 Stearate (UNII: YD01N1999R)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59555-106-0350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/21/2015
    2NDC:59555-106-113785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/21/2015
    3NDC:59555-106-083785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/21/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35212/21/2015
    Labeler - R & R Lotion, Inc (062979000)
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