SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [FAMILY DOLLAR SERVICES, INC.]

SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [FAMILY DOLLAR SERVICES, INC.]
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NDC 55319-790-30
Set ID 93feb534-5aa6-40cd-b96f-8b1e2c923e73
Category HUMAN OTC DRUG LABEL
Packager Family Dollar Services, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 2%

    Oxybenzone 4%

  • Purpose

    Sunscreen

  • Use

    • 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

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

  • 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 occurs

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center Right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • 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 value 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-sleeved shirts, pants, hats and sunglasses
    • children under 6 months of age: Ask a doctor
  • Other information

    • protect the product from excessive heat and direct sun
    • avoid long term storage above 40°C (104°F)
  • Inactive ingredients

    alcohol denat., acrylates/octylacrylamide copolymer, glycerin, tocopherol, fragrance, caprylic/capric triglyceride

  • SPL UNCLASSIFIED SECTION

    May stain or damage some fabrics or surfaces

    *This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Continuous Spray Ultra Guard Broad Spectrum SPF 30.

    Distributed by: Family Dollar Services Inc.

    10401 Monroe Rd., Matthews, NC 28105, USA

  • principal display panel

    Tropic Sun

    Ultra Sunscreen Spray

    Broad spectrum SPF 30

    Compare to Coppertone Ultraguard Sunscreen*

    SPF 30

    Water resistant (80 minutes)

    UVA/UVB sunscreen

    Paraben free

    NET WT 6 OZ (170 g)Tropic Sun

    Ultra Sunscreen Spray

    Broad spectrum SPF 30

    Compare to Coppertone Ultraguard Sunscreen*

    SPF 30

    Water resistant (80 minutes)

    UVA/UVB sunscreen

    Paraben free

    NET WT 6 OZ (170 g)

    image description

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-790
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone25.95 mg  in 1 g
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate86.5 mg  in 1 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate43.25 mg  in 1 g
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene17.3 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE34.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER (UNII: R0R8I3X29J)  
    glycerin (UNII: PDC6A3C0OX)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-790-30170 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/07/2017
    Labeler - Family Dollar Services, Inc. (024472631)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55319-790)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55319-790)

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