DAILY ANTI-AGING MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN UVA-UVB SUNSCREEN WITH SOLSCI-X (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [MDSOLARSCIENCES]

DAILY ANTI-AGING MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN UVA-UVB SUNSCREEN WITH SOLSCI-X (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) LOTION [MDSOLARSCIENCES]
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NDC 49358-555-01, 49358-555-02
Set ID 36962d03-cc5e-45a5-a37b-8d5cd8e11c1a
Category HUMAN OTC DRUG LABEL
Packager MDSolarSciences
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients:Purpose
    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

    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 liberally 15 minutes before sun exposure
    • Reapply:
      -
      At least every 2 hours
      -
      Use a water resistant sunscreen if swimming or sweating
      -
      Immediately after towel drying
    • 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 10 a.m. - 2 p.m.
      -
      Wear long-sleeved shirts, pants, hats and sunglasses
  • Other information

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

    Water, Butyloctyl Salicylate, Coco-Caprylate/Caprate, Glycerin, Sorbitol, Lecithin, Aloe Barbadensis Leaf Extract, Caffeine, Zea Mays (Corn) Oil, Proline, Xanthan Gum, Sodium Ascorbyl Phosphate, Rosa Moschata Seed Oil, Niacinamide, Vitis Vinifera (Grape) Callus Culture Extract, Chamomilla Recutita (Matricaria) Flower Extract, Camellia Sinensis (Green Tea) Extract, Diatomaceous Earth, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Laminaria Digitata Extract, Tremella Fuciformis (Mushroom) Extract, Ferric Hexapeptide-35, Sesamum Indicum (Sesame) Seed Oil, Macadamia Integrifolia Seed Oil, Olea Europaea (Olive) Fruit Oil, Polysilicone-15, Sodium Hyaluronate, Dimethicone, Ceteareth-25, Cetyl Alcohol, Behenic Acid, Cholesterol, Ceramide NP, Ceramide NS, Ceramide EOS, Ceramide EOP, Ceramide AP, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Caprylic/ Capric Triglyceride, Teprenone, Sodium Stearoyl Glutamate, Polyester-8, Caprylhydroxamic Acid, Caprylyl Glycol, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Panthenol, Sodium Polyacrylate, Mica, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Sodium Hydroxide

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

    MDSolarSciences

    30

    DAILY
    ANTI-AGING
    MOISTURIZER

    with SolSci-X™

    BROAD SPECTRUM
    SPF 30
    UVA-UVB SUNSCREEN

    +R
    enhanced with
    ProVention-R™

    developed & approved
    by Dermatologists

    Non-comedogenic – won't clog pores

    sun repair

    50 mL - 1.7 Fl. Oz.

    Principal Display Panel - 50 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    DAILY ANTI-AGING MOISTURIZER   BROAD SPECTRUM SPF30 SUNSCREEN UVA-UVB SUNSCREEN WITH SOLSCI-X
    avobenzone, octisalate, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49358-555
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene27.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Coco-Caprylate/Caprate (UNII: 8D9H4QU99H)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sorbitol (UNII: 506T60A25R)  
    Hydrogenated Soybean Lecithin (UNII: H1109Z9J4N)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Caffeine (UNII: 3G6A5W338E)  
    Corn Oil (UNII: 8470G57WFM)  
    Proline (UNII: 9DLQ4CIU6V)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Sodium Ascorbyl Phosphate (UNII: 836SJG51DR)  
    Rosa Moschata Seed Oil (UNII: T031ZE559T)  
    Niacinamide (UNII: 25X51I8RD4)  
    Vitis Vinifera Seed (UNII: C34U15ICXA)  
    Chamomile (UNII: FGL3685T2X)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Diatomaceous Earth (UNII: 2RF6EJ0M85)  
    Helianthus Annuus Flowering Top (UNII: BKJ0J3D1BP)  
    Rosemary (UNII: IJ67X351P9)  
    Laminaria Digitata (UNII: 15E7C67EE8)  
    Tremella Fuciformis Fruiting Body (UNII: GG8N28393G)  
    Acetyl Hexapeptide-8 (UNII: L4EL31FWIL)  
    Sesame Oil (UNII: QX10HYY4QV)  
    Macadamia Oil (UNII: 515610SU8C)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Polysilicone-15 (UNII: F8DRP5BB29)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Ceteareth-25 (UNII: 8FA93U5T67)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Behenic Acid (UNII: H390488X0A)  
    Cholesterol (UNII: 97C5T2UQ7J)  
    Ceramide NP (UNII: 4370DF050B)  
    Ceramide NG (UNII: C04977SRJ5)  
    3-Dehydroxy Ceramide 1 (UNII: CR0J8RN66K)  
    Ceramide 9 (UNII: 88KCS7120E)  
    Ceramide AP (UNII: F1X8L2B00J)  
    Caprooyl Tetrapeptide-3 (UNII: LZI0HJ3K2R)  
    N-Hexanoylsphingosine (UNII: 038753E78J)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Teprenone (UNII: S8S8451A4O)  
    Sodium Stearoyl Glutamate (UNII: 65A9F4P024)  
    Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) (UNII: T9296U138P)  
    Caprylhydroxamic Acid (UNII: UPY805K99W)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)  
    Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
    Allantoin (UNII: 344S277G0Z)  
    Panthenol (UNII: WV9CM0O67Z)  
    Sodium Polyacrylate (8000 MW) (UNII: 285CYO341L)  
    Mica (UNII: V8A1AW0880)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Lavender Oil (UNII: ZBP1YXW0H8)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49358-555-011 in 1 CARTON03/01/2016
    150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:49358-555-021 in 1 CARTON03/01/2016
    215 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35203/01/2016
    Labeler - MDSolarSciences (013647301)

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