Label: MDSOLARSCIENCES SPF 40 QUICK DRY- avobenzone, octisalate, and octocrylene spray

  • 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 April 24, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients:Purpose
    Avobenzone 3.00%Sunscreen
    Octisalate 5.00%Sunscreen
    Octocrylene 2.75%Sunscreen
  • Uses

    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
    • Retains SPF after 80 minutes of activity in water
  • Warnings

    For external use only.

    When using this product keep out of eyes. Rinse with water to remove.

    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 Poison Control Center right away.

  • STORAGE AND HANDLING

    • Use in well ventilated areas
    • Do not puncture or incinerate
    • Contents under pressure
    • Do not store above 120°F/48°C
    • Avoid long term storage above 104°F/40°C
    • FLAMMABLE
    • Do not use near heat, flame or while smoking
  • Directions

    • Apply generously 30 minutes before sun exposure and as needed
    • Do not spray on face
    • Spray on hands and rub well into face and scalp
    • Reapply every 2 hours, or after swimming, excessive perspiration, towel drying or extended sun exposure
    • Children under 6 months of age: ask a doctor
    • Effective sun protection for children under 2 years of age is strongly recommended
  • Other information

    Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

    • 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, EDTA, Phytic Acid, Phyllanthus Emblica Fruit Extract, Tetrahexyldecyl Ascorbate, Trisodium Ethylenediamine Disuccinate

  • PRINCIPAL DISPLAY PANEL - 148 mL Can Carton

    MDSolarSciences

    SPF 40
    with
    SolSciX

    Broad Spectrum
    UVA-UVB Sunscreen

    Quick Dry
    Body Spray

    EASY APPLICATION

    for Active Lifestyles

    Light & Non-Greasy
    Very Water Resistant
    No Fragrance

    Dermatologist Developed

    Includes our
    SolALERT
    UV Index
    Card

    148 mL- 5.0 Fl. Oz.

    PRINCIPAL DISPLAY PANEL - 148 mL Can Carton
  • INGREDIENTS AND APPEARANCE
    MDSOLARSCIENCES   SPF 40 QUICK DRY
    avobenzone, octisalate, and octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-544
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone4.44 mL  in 148 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate7.4 mL  in 148 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene4.07 mL  in 148 mL
    Inactive Ingredients
    Ingredient NameStrength
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Diisopropyl Adipate (UNII: P7E6YFV72X)  
    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:49358-544-011 in 1 CARTON
    1148 mL in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35202/01/2012
    Labeler - MD Solar Sciences (013647301)
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