Label: DERMATOUCH HYDRATING CLEAR MOISUTRIZER SPF 25- avobenzone, homosalate, octisalate lotion

  • 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 January 18, 2022

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  • Active Ingredients

    Avobenzone 3.0%

    Homosalate 15.0%

    Octisalate 5.0%

  • Purpose

    Sunscreen

  • Warnings

    Warnings:

    . For external use only. . Do not use on damaged or broken skin.

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

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

    . If swallowed, seek medical help or contact a poison control center right away.

    . Keep out of reach of children.

    . Jar is glass and may shatter if dropped.

  • Directions

    Directions: Apply generously and evenly thirty minutes before sun exposure. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating. Children under six months of age: Consult a doctor.

  • Inactive Ingredients

    Inactive Ingredients: Aqua, SD Alcohol 40-B, Glycerin, Cetearyl Ethylhexanoate, Ammonium Polyacryloyldimethyl Taurate, *CO Glycerin, *CO Humulus Lupulus (Hops) Extract, *CO Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, *CO Calendula Officinalis Flower Extract, *CO Chamomilla Recutita (Matricaria) Flower Extract, *CO Citrus Limon (Lemon) Peel Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Camellia Sinensis Leaf Extract, *CO Pyrus Malus (Apple) Fruit Extract, *CO Spirulina Platensis Extract, Phenoxyethanol, Ethylhexylglycerin *Certified Organic

  • INDICATIONS & USAGE

    Uses: . Helps prevent sunburn. . Higher SPF gives more sunburn protection. . 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.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Principal Display Panel

    DermatouchSPF25fda.jpg

  • INGREDIENTS AND APPEARANCE
    DERMATOUCH HYDRATING CLEAR MOISUTRIZER SPF 25 
    avobenzone, homosalate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-8309
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 mg  in 50 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 mg  in 50 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    MATRICARIA CHAMOMILLA LEAF (UNII: 6I9LN466F0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68062-8309-150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/18/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/18/2022
    Labeler - Spa de Soleil (874682867)
    Establishment
    NameAddressID/FEIBusiness Operations
    Spa de Soleil874682867manufacture(68062-8309)
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