SUNSCREEN FOR KIDS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [DOLGENCORP, LLC]

SUNSCREEN FOR KIDS (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [DOLGENCORP, LLC]
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NDC 55910-704-34
Set ID 79c83928-28e0-4c0b-b58b-655c8b638772
Category HUMAN OTC DRUG LABEL
Packager DOLGENCORP, LLC
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, tocopherol, chlorphenesin, polyglyceryl-3 distearate, fragrance, carbomer, disodium EDTA

  • Disclaimer

    May stain or damage some fabrics or surfaces

    This product is not being compared to Coppertone Kids Sunscreen SPF 50 for any other purpose and this product is not manufactured or distributed by Bayer, dstributor of Coppertone KIDS Sunscreen Lotion SPF 50

  • Adverse reactions

    DISTRIBUTED BY DOLGENCORP, LLC

    100 MISSION RIDGE,

    GOODLETTSVILLE, TN 37072

    100%

    Satisfaction

    Guaranteed!

    (888)309-9030

    704.000/704AB

  • Principal Display Panel

    DG body

    Compare to the SPF

    of Coppertone Kids

    Sunscreen

    for kids

    Broad Spectrum

    SPF 50

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

    SPF

    50

    8 FL OZ (237 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN FOR KIDS 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-704
    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:55910-704-34237 mL in 1 BOTTLE, PLASTIC; 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 - DOLGENCORP, LLC (068331990)
    Registrant - Vi-Jon, Inc (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, Inc790752542manufacture(55910-704)

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