KARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]

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  • KARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]

KARA VITA MOISTURIZING SUNSCREEN WITH DNARESCUE (OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [KARA VITA, INC.]
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NDC 68572-6018-4
Set ID 2130e9ac-5946-4b00-94d0-a78fd1ccfd13
Category HUMAN OTC DRUG LABEL
Packager Kara Vita, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Benzophenone-3 6.0%
    Butyl Methoxydibenzoylmethane 3.0%
    Ethylhexyl Methoxycinnamate 7.5%
    Ethylhexyl Salicylate 5.0%
    Homosalate 6.0%

  • Purpose

    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 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 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
      • immediately after towel drying
      • at least 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 10 a.m. - 2 p.m.
      • wear long-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • Inactive ingredients

    purified water, potassium cetyl phosphate, sorbitol, dicaprylyl maleate, alcohol, lecithin, artemia extract, tocopheryl acetate, aloe barbadensis leaf juice, dimethicone, carbomer, cetyl alchohol, methylparaben, propylparaben, triethanolamine

  • SPL UNCLASSIFIED SECTION

    Manufactured for Kara Vita by:
    Dermazone Solutions
    St. Petersburg, FL 33713
    1.727.456.7560

  • PRINCIPAL DISPLAY PANEL - 113 g Bottle Carton

    KARA VITA

    Moisturizing
    Sunscreen     with
    DNArescue™

    SPF
    29 ACTIVE

    BROAD SPECTRUM

    WATER RESISTANT
    (80 MINUTES)

    4 OZ (113 g)

    Principal Display Panel - 113 g Bottle Carton
  • INGREDIENTS AND APPEARANCE
    KARA VITA   MOISTURIZING SUNSCREEN WITH DNARESCUE
    oxybenzone, avobenzone, octinoxate, octisalate, and homosalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68572-6018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE60 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    potassium cetyl phosphate (UNII: 03KCY6P7UT)  
    sorbitol (UNII: 506T60A25R)  
    dioctyl maleate (UNII: OD88G8439L)  
    alcohol (UNII: 3K9958V90M)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    dimethicone (UNII: 92RU3N3Y1O)  
    cetyl alcohol (UNII: 936JST6JCN)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68572-6018-41 in 1 CARTON10/15/2015
    1113 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/15/2015
    Labeler - Kara Vita, Inc. (140693388)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deramzone Solutions, Inc.136116865MANUFACTURE(68572-6018)
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