SUNTONE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]

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SUNTONE BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, AND OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]
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NDC 13630-0059-4
Set ID 7a9c29fc-9e88-44dc-9337-34879103810b
Category HUMAN OTC DRUG LABEL
Packager Prime Packaging, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active ingredients

    Avobenzone 2 %, Octisalate 5 %, and  Octocrylene 1.85 %

  • PURPOSE

    Purpose

    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.

    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 0F

    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 well-ventilated areas.
    • reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours

    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this 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-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • Inactive Ingredients

    Fragrance (Parfum), SD Alcohol 40-B (Alcohol Denat.), Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

  • Other information

    • protect this product from excesive heat and direct sun
    • may stain some fabrics
  • QUESTIONS

    Questions or Comments? Biocycle Laboratories, Inc.

    16363 NW 49th Avenue, Miami, FL 33014

  • PRINCIPAL DISPLAY PANEL - 177 mL Can Label

    PRINCIPAL DISPLAY PANEL - 177 mL Can Label
    Suntone

    Fit for the Sun

    Sunscreen

    CONTINUOUS SPRAY

    BROAD SPECTRUM SPF 15

    Water Resistant (80 Minutes)

    Non-Greasy Formula

    15

    6 FL. OZ. / 177 mL

  • INGREDIENTS AND APPEARANCE
    SUNTONE  BROAD SPECTRUM SPF 15
    avobenzone, octisalate, and octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0059
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE16.2 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40.5 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE14.9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIBUTYL MALEATE (UNII: 4X371TMK9K)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0059-4177 mL in 1 CAN; Type 0: Not a Combination Product04/05/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/05/2013
    Labeler - Prime Packaging, Inc. (805987059)
    Registrant - Prime Packaging, Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(13630-0059) , analysis(13630-0059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging, Inc.805987059label(13630-0059) , pack(13630-0059)
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