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

SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [FAMILY DOLLAR SERVICES, INC]
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NDC 55319-764-21, 55319-764-34
Set ID eccbe598-e07f-4fde-883b-48fd37115e7a
Category HUMAN OTC DRUG LABEL
Packager Family Dollar Services, Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Avobenzone 3%

    Homosalate 11.7%

    Octisalate 4.5%

    Octocrylene 4.5%

    Oxybenzone 5.4%

  • 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 use  reqularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especiallyu 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, propylene glycol, neopentyl glycol diheptanoate, styrene/acrylates copolymer, benzyl alcohol, tocopherol, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer, oleth-3, polyamide-8, chlorphenesin, sodium ascorbyl phosphate, fragrance, 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 Sport High Performance Sunscreen Broad Spectrum SPF 50.

    Distributed by:

    Family Dollar Services Inc.

    10401 Monroe Rd., Matthews, NC 28105, USA

  • principal display panel

    Tropic Sun

    Sport Sunscreen Lotion

    Broad spectrum SPF 50

    Compare to Coppertone Sport Sunscreen*

    SPF 50

    Water resistant (80 minutes)

    UVA/UVB sunscreen

    Paraben free

    3 FL OZ (89 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-764
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.6 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE119 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45.9 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE45.9 mg  in 1 mL
    oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) oxybenzone55.08 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    OLETH-3 (UNII: BQZ26235UC)  
    POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-764-2189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2016
    2NDC:55319-764-34236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/12/2016
    Labeler - Family Dollar Services, Inc (024472631)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55319-764)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55319-764)

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