AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION [FAMILY DOLLAR SERVICES INC.]

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION [FAMILY DOLLAR SERVICES INC.]
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NDC 55319-704-21
Set ID 96bd0a23-b37c-4b02-a803-1746779f032d
Category HUMAN OTC DRUG LABEL
Packager Family Dollar Services Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Avobenzone 3%

    Homosalate 13%

    Octisalate 5%

    Octocrylene 7%

    Oxybenzone 4%

  • Purpose

    Sunscreen

  • Use

    • helps prevent sunburn
    • if used as directed with other sun protections measures (see Directions), decreases the rist 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
  • 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 a 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
  • Inactive ingredients

    water, sorbitol, triethanolamine, VP/eicosene copolymer, stearic acid, sorbitan isostearate, aluminum starch octenylsuccinate, benzyl alcohol, dimethicone, tocopheryl, chlorphenesin, polyglyceryl-3 distearate, fragrance, carbomer, disodium EDTA

  • SPL UNCLASSIFIED SECTION

    May stain or damage some fabrics or surfaces

    *This product is not manufactured or distributed by Bayer, distributor of Coppertone Ultra Guard Sunscreen Lotion Broad Spectrum SPF 50.

    Distributed by:  Family Dollar Services Inc.

    10401 Monroe Rd., Matthews, NC 28105, USA

  • principal display panel

    Tropic Sun

    Sunscreen for Kids

    Broad Spectrum SPF 50

    *compare to the SPF of Coppertone Kids Sunscreen

    SPF 50

    Water resistant (80 minutes)

    UVA/UVB Sunscreen

    Pediatrician tested

    Paraben free

    3 FL OZ (89 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-704
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.9 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE133.9 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE51.5 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE72.1 mg  in 1 mL
    oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) oxybenzone41.2   in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-704-2189 mL in 1 CAN; Type 0: Not a Combination Product12/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/01/2017
    Labeler - Family Dollar Services Inc. (024472631)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55319-704)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55319-704)

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