SUNTONE FIT FOR THE SUN SPORT SUNSCREEN BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING INC.]

SUNTONE FIT FOR THE SUN SPORT SUNSCREEN BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING INC.]
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NDC 13630-0129-4
Set ID 686bf17c-26e0-de09-e053-2a91aa0a39cb
Category HUMAN OTC DRUG LABEL
Packager Prime Packaging Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Avobenzone 3%

    Homosalate 7.5%

    Octisalate 5%

    Octocrylene 2.75%

    Oxybenzone 2%

  • 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°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 and 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 snscreen with a 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 excessive heat and direct sun
    • avoid spraying on fabrics - could cause discoloration
  • Questions or comments?

    Biocycle Laboratories, Inc. 16363 NW 49 Avenuw, Miami, FL 33014

  • Suntone Sport Sunscreen Continuous Spray Broad Spectrum SPF 30

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    SUNTONE  FIT FOR THE SUN SPORT SUNSCREEN BROAD SPECTRUM SPF 30
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0129
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE24.9 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE41.5 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE22.83 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE16.6 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE62.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIBUTYL MALEATE (UNII: 4X371TMK9K)  
    ALCOHOL (UNII: 3K9958V90M)  
    VINYL ACETATE (UNII: L9MK238N77)  
    ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
    Product Characteristics
    Coloryellow (Colorless to light yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0129-4177 mL in 1 CAN; Type 0: Not a Combination Product04/16/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/16/2018
    Labeler - Prime Packaging Inc. (805987059)
    Registrant - Prime Packaging Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc101946028manufacture(13630-0129) , analysis(13630-0129)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging Inc.805987059pack(13630-0129) , label(13630-0129)

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