Label: KERAS DAY SHIELD BROAD SPECTRUM SPF 25- octinoxate, avobenzone, and octocrylene lotion
RETROSPECT DAY SHIELD BROAD SPECTRUM SPF 25- octinoxate, avobenzone, and octocrylene lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 30, 2011

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  • 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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