Label: SOLMATE BROAD SPECTRUM SPF 8- avobenzone, octisalate, octocrylene, and oxybenzone aerosol, 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 January 17, 2020

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  • Active ingredients

    Avobenzone 1 %, Octisalate 3 %,  Octocrylene 0.85 %, and Oxybenzone 1 %

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

    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.

     •Keep away from face to avoid breathing it.

    •Contents under pressure-do not puncture or incinerate. Do not store at temperatures above 120°F

    Stop use and ask a doctor if rash occurs

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

    Flammable: Do not use near heat, flame or while smoking.

  • Directions

    • spray liberally and spread evenly by hand 15 minutes before sun exposure
    • hold container 4 to 6 inches from the skin to apply
    • do not spray directly into face. Spray on hands then apply to face.
    • do not apply in windy conditions
    • use in a well-ventilated area
    • reapply:
    • After 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • children under 6 months: Ask a doctor
  • Inactive Ingredients

    C12-15 Alkyl Benzoate, Fragrance (Parfum), SD Alcohol 40-B (Alcohol Denat.), VA/Butyl Maleate/Isobornyl Acrylate Copolymer

  • Other Information

    •protect this product from excessive heat and direct sun

     •may stain fabrics.

  • Questions or comments? Biocycle Laboratories, Inc.

    16363 NW 49 Avenue, Miami, Fl 33014

  • PRINCIPAL DISPLAY PANEL - 177 mL Can Label

    PRINCIPAL DISPLAY PANEL - 177mL Can Label

    SOL

    MATE

    Love the Sun

    Continuous Spray

    Sunscreen

    8

    Broad Spectrum SPF 8

    Water Resistant (80) Minutes

    Non-Greasy Formula

  • INGREDIENTS AND APPEARANCE
    SOLMATE  BROAD SPECTRUM SPF 8
    avobenzone, octisalate, octocrylene, and oxybenzone aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0075
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE8.1 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE24.3 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6.885 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE8.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYL MALEURATE (UNII: 6FUA0H660I)  
    ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0075-4177 mL in 1 CAN; Type 0: Not a Combination Product03/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/01/2015
    Labeler - Prime Packaging, Inc. (805987059)
    Registrant - Prime Packaging, Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028analysis(13630-0075) , manufacture(13630-0075)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging, Inc.805987059label(13630-0075) , pack(13630-0075)
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