SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [DOLGENCORP, LLC]

SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [DOLGENCORP, LLC]
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NDC 55910-789-30
Set ID 449208a0-e89e-4844-a6a0-b72c928fa0e2
Category HUMAN OTC DRUG LABEL
Packager DOLGENCORP, LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 4%

    Oxybenzone 5%

  • 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 50

    100% Satisfaction Guaranteed!

    (888)309-9030

    DISTRIBUTED BY DOLGENCORP, LLC

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

    789.000/789AA

  • Principal Display Panel

    DG body

    Compare to the active ingredients in Coppertone

    Ultra Sunscreen Spray

    Broad Spectrum SPF 50

    • Water Resistant (80 minutes)
    • UVA/UVB Sunscreen

    SPF 50

    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:55910-789
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone26.07 mg  in 1 g
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate86.9 mg  in 1 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate43.45 mg  in 1 g
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene34.76 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE43.45 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:55910-789-30170 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/28/2017
    Labeler - DOLGENCORP, LLC (068331990)
    Registrant - Vi-Jon, Inc. (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, Inc.790752542manufacture(55910-789)

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