KERAS DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [KERAPLAST

KERAS DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25 (OCTINOXATE, AVOBENZONE, AND OCTOCRYLENE) LOTION [KERAPLAST
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NDC 24854-300-50, 24854-400-50
Set ID 1a784b0e-a517-4510-a547-1334febfc0aa
Category HUMAN OTC DRUG LABEL
Packager Keraplast Technologies LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Octinoxate 5%

    Avobenzone 3%

    Octocrylene 8%

  • 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

    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

    • Apply in the morning over intensive serum as a moisturizing sunscreen. Smooth over face and neck, massaging in upward, outward, circular motions.
    • Apply at least 15 minutes before sun exposure.
    • Reapply every 2 hours if skin is being exposed to the sun.
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early signs of 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 am to 2 pm
      • Wear long sleeved shirts, pants, hats, and sunglasses
    • Children under 6 months: Ask a doctor
  • Inactive ingredients

    Water, Cetearyl Alcohol, Isopropyl Palmitate, Ceteareth-20, Keratin, Hydrolyzed keratin, Glycerin, Sucrose Polybehenate, Gluconolactone, Sodium benzoate, Potassium sorbate, fragrance

  • Other information

    Protect this product from excessive heat and direct sun

  • SPL UNCLASSIFIED SECTION

    Manufactured in
    New Zealand
    for
    Keraplast Technologies, LLC.
    San Antonio, TX 78258

  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

    K
    KERAS

    DAY SHIELD
    BROAD SPECTRUM
    SPF 25

    For All Skin Types

    Net Contents
    1.7 Fl.Oz./50 ml

    Principal Display Panel - 50 ml Bottle Carton
  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

    RETROSPECT

    DAY SHIELD
    BROAD
    SPECTRUM
    SPF 25

    For All Skin Types

    Net Contents
    1.7 Fl.Oz./50 ml

    Principal Display Panel - 50 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    KERAS DAY SHIELD BROAD SPECTRUM SPF 25 
    octinoxate, avobenzone, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24854-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate0.25 g  in 50 mL
    avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX) avobenzone0.15 g  in 50 mL
    octocrylene (UNII: 5A68WGF6WM) (octocrylene - UNII:5A68WGF6WM) octocrylene0.4 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    isopropyl palmitate (UNII: 8CRQ2TH63M)  
    polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
    glycerin (UNII: PDC6A3C0OX)  
    gluconolactone (UNII: WQ29KQ9POT)  
    sodium benzoate (UNII: OJ245FE5EU)  
    potassium sorbate (UNII: 1VPU26JZZ4)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24854-400-501 in 1 CARTON
    150 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35211/30/2011
    RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25 
    octinoxate, avobenzone, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24854-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    octinoxate (UNII: 4Y5P7MUD51) (octinoxate - UNII:4Y5P7MUD51) octinoxate0.25 g  in 50 mL
    avobenzone (UNII: G63QQF2NOX) (avobenzone - UNII:G63QQF2NOX) avobenzone0.15 g  in 50 mL
    octocrylene (UNII: 5A68WGF6WM) (octocrylene - UNII:5A68WGF6WM) octocrylene0.4 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    isopropyl palmitate (UNII: 8CRQ2TH63M)  
    polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
    glycerin (UNII: PDC6A3C0OX)  
    gluconolactone (UNII: WQ29KQ9POT)  
    sodium benzoate (UNII: OJ245FE5EU)  
    potassium sorbate (UNII: 1VPU26JZZ4)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24854-300-501 in 1 CARTON
    150 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35211/30/2011
    Labeler - Keraplast Technologies LLC (009952821)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Cosmetic Company590563383LABEL, MANUFACTURE, PACK

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