Label: QUICK DRY BODY BROAD SPECTRUM SPF40 SUNSCREEN UVA-UVB SUNSCREEN WITH SOLSCI-X- avobenzone, octisalate, and octocrylene spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 4, 2018

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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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