QUICK DRY BODY BROAD SPECTRUM SPF40 SUNSCREEN UVA-UVB SUNSCREEN WITH SOLSCI-X (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) SPRAY [MDSOLARSCIENCES]

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  • QUICK DRY BODY BROAD SPECTRUM SPF40 SUNSCREEN UVA-UVB SUNSCREEN WITH SOLSCI-X (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) SPRAY [MDSOLARSCIENCES]

QUICK DRY BODY BROAD SPECTRUM SPF40 SUNSCREEN UVA-UVB SUNSCREEN WITH SOLSCI-X (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) SPRAY [MDSOLARSCIENCES]
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NDC 49358-556-01
Set ID 812caa99-1e1e-4ab8-9f9a-fb3384c684dd
Category HUMAN OTC DRUG LABEL
Packager MDSolarSciences
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Avobenzone 3%Sunscreen
    Octisalate 5%Sunscreen
    Octocrylene 2.75%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

    When using this product avoid spraying in eyes. Rinse with water to remove.

    Do not use on damaged or broken skin

    Stop use and ask a doctor if rash or irritation develops and lasts.

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

  • Flammable

    Do not puncture or incinerate

    Contents under pressure (compressed air)

    Do not use near heat or flame or while smoking

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Spray on hands and rub well into face and scalp
    • Reapply:
      -
      After 80 minutes of swimming or sweating
      -
      Immediately after towel drying
      -
      At least every 2 hours
    • Children under 6 months: Ask a doctor
    • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:
      -
      Limit time in the sun, especially from 10a.m. – 2p.m.
      -
      Wear long-sleeved shirts, pants, hats and sunglasses.
  • Other Information

    • Protect the product in this container from excessive heat
    • May stain some fabrics
    • You may report serious adverse reactions to Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222
  • Inactive ingredients

    SD Alcohol 40, Butyloctyl Salicylate, Polyester-8, Caprylyl Methicone, Diisopropyl Adipate, Acrylates/Octylacrylamide Copolymer, Tetrahexlydecyl Ascorbate, EDTA, Phytic Acid, Phyllanthus Emblica Fruit Extract, Trisodium Ethylenediamine Disuccinate

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    MDSolarSciences Corp.
    40 Richards Avenue, 3rd Fl., Norwalk, CT 06854

  • PRINCIPAL DISPLAY PANEL - 148 mL Can Carton

    MDSolarSciences™

    40
    QUICK DRY
    BODY
    SPRAY
    with SolSci-X    ™

    BROAD SPECTRUM
    SPF 40
    UVA-UVB SUNSCREEN

    +R
    enhanced with
    ProVention-R    ™

    developed & approved
    by Dermatologists

    Water resistant (80 minutes)
    Non-comedogenic – won't clog pores

    sun care

    Net Wt. 148 mL - 5 Fl. Oz.

    PRINCIPAL DISPLAY PANEL - 148 mL Can Carton
  • INGREDIENTS AND APPEARANCE
    QUICK DRY BODY  BROAD SPECTRUM SPF40 SUNSCREEN UVA-UVB SUNSCREEN WITH SOLSCI-X
    avobenzone, octisalate, and octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-556
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 g  in 100 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene2.75 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Polyester-8 (1400 MW, Cyanodiphenylpropenoyl Capped) (UNII: T9296U138P)  
    Caprylyl Trisiloxane (UNII: Q95M2P1KJL)  
    Diisopropyl Adipate (UNII: P7E6YFV72X)  
    Carbomer Copolymer Type A (Allyl Pentaerythritol Crosslinked) (UNII: 71DD5V995L)  
    Edetic Acid (UNII: 9G34HU7RV0)  
    Fytic Acid (UNII: 7IGF0S7R8I)  
    Phyllanthus Emblica Fruit (UNII: YLX4CW2576)  
    Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49358-556-011 in 1 CARTON03/01/2015
    1148 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35203/01/2015
    Labeler - MDSolarSciences (013647301)
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