SUNTONE BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]

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  • SUNTONE BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]

SUNTONE BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]
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Set ID 32581872-6960-45d9-a0e0-1291d6a7ebf8
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 1 %, Octisalate 3 %, Octocrylene 0.85 %, and Oxybenzone 1 %

  • PURPOSE

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings


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

    For exernal 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 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
    • 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 excesive heat and direct sun
    • may stain some fabrics
  • QUESTIONS

    Questions or Comments? Biocycle Laboratories, Inc.

     16363 NW 49 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 8

    Water Resistant (80 minutes)

    Non-Greasy Formula

    8

    6 FL.OZ./ 177mL

  • INGREDIENTS AND APPEARANCE
    SUNTONE  BROAD SPECTRUM SPF 8
    avobenzone, octisalate, octocrylene and oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0046
    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) OCTOCRYLENE6.9 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)  
    Product Characteristics
    ColoryellowScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0046-4177 mL in 1 CAN; Type 0: Not a Combination Product03/21/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/21/2013
    Labeler - Prime Packaging, Inc. (805987059)
    Registrant - Prime Packaging, Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(13630-0046) , analysis(13630-0046)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging, Inc.805987059label(13630-0046) , pack(13630-0046)
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