NANOCARE MOISTURIZING SUNSCREEN SPF 50 (BENZOPHENONE, AVOBENZONE, OCTISALATE, HOMOSALATE, AND OCTOCRYLENE) LOTION [DERAMZONE SOLUTIONS, INC.]

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  • NANOCARE MOISTURIZING SUNSCREEN SPF 50 (BENZOPHENONE, AVOBENZONE, OCTISALATE, HOMOSALATE, AND OCTOCRYLENE) LOTION [DERAMZONE SOLUTIONS, INC.]

NANOCARE MOISTURIZING SUNSCREEN SPF 50 (BENZOPHENONE, AVOBENZONE, OCTISALATE, HOMOSALATE, AND OCTOCRYLENE) LOTION [DERAMZONE SOLUTIONS, INC.]
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NDC 58466-033-33
Set ID 5a68508b-f1fa-4f03-b28a-554e24cf58d6
Category HUMAN OTC DRUG LABEL
Packager Deramzone Solutions, 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 Salicylate 5.0%
    Homosalate 10.0%
    Octocrylene 8.0%

  • Purpose

  • 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

    USP water, potassium cetyl phosphate, alcohol, dicaprylyl maleate, sorbitol, bis-stearyl/ethylenediamine/neopentyl glycol/stearyl hydrogenated dimmer dilinoleate copolymer, cetyl alcohol, lecithin, aloe barbadensis leaf juice, carbomer, tocopheryl acetate, methylparaben, propylparaben, triethanolamine

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Dermazone Solutions, Inc.
    2440 30th Avenue North St. Petersburg, FL 33713 USA

    Distributed by: Universal Sales & Marketing, Inc.

  • PRINCIPAL DISPLAY PANEL - 88 mL Tube Carton

    nanocare
    for skin

    Moisturizing Sunscreen
    SPF 50

    Broad Spectrum Protection

    WATER RESISTANT
    (80 MINUTES)

    Clinical Skin Care
    with Lyphazome® Technology

    3.0 FL OZ (88 mL)

    PRINCIPAL DISPLAY PANEL - 88 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    NANOCARE   MOISTURIZING SUNSCREEN SPF 50
    benzophenone, avobenzone, octisalate, homosalate, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58466-033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzophenone (UNII: 701M4TTV9O) (Benzophenone - UNII:701M4TTV9O) Benzophenone60 mg  in 1 mL
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate100 mg  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene80 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    potassium cetyl phosphate (UNII: 03KCY6P7UT)  
    alcohol (UNII: 3K9958V90M)  
    dioctyl maleate (UNII: OD88G8439L)  
    sorbitol (UNII: 506T60A25R)  
    cetyl alcohol (UNII: 936JST6JCN)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58466-033-331 in 1 CARTON
    188 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/15/2012
    Labeler - Deramzone Solutions, Inc. (136116865)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deramzone Solutions, Inc.136116865MANUFACTURE(58466-033)
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