KIDS SUNSCREEN SPF 50 (AVOBENZONE 3.0% HOMOSALATE 15.0% OCTISALATE 5.0% OCTOCRYLENE 10.0%) SPRAY [WEGMAN]

KIDS SUNSCREEN SPF 50 (AVOBENZONE 3.0% HOMOSALATE 15.0% OCTISALATE 5.0% OCTOCRYLENE 10.0%) SPRAY [WEGMAN]
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NDC 47124-116-05, 47124-116-10
Set ID 0c596b1d-8c23-4598-8b6f-95e1679069b9
Category HUMAN OTC DRUG LABEL
Packager Wegman
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients                                                                             Purpose


    Avobenzone 3%..................................................................................Sunscreen
    Homosalate 15%.................................................................................Sunscreen
    Octisalate 5%......................................................................................Sunscreen
    Octocrylene 10%.................................................................................Sunscreen

  • PURPOSE

  • INDICATIONS & USAGE

    Uses • helps prevent sunburn • higher SPF gives more sunburn protection
    • retains SPF after 80 minutes of activity in the water or sweating • provides
    high protection against sunburn

  • WarningsFor external use only

    Flammable: Do not use near heat, flme, or while smoking.
    Do not use on damaged or broken skin
    When using this product • Keep out of eyes. Rinse eyes with water to remove.
    Stop use and ask a doctor if rash occurs
    Keep out of reach of children. If product is swallowed, get medical help or
    contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions • spray liberally and spread evenly by hand 15 minutes before sun
    exposure • reapply: • after 80 minutes of swimming or sweating • immediately after
    towel drying • at least every 2 hours • hold container 4 to 6 inches from the skin to apply
    • do not spray directly into face. Spray on hands then apply to face. • do not apply in
    windy conditions • use in a well-ventilated area
    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 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-sleeve shirts,
    pants, hats, and sunglasses
    • children under 6 months: Ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients: Acrylates/Octylacrylamide, Copolymer, Alcohol Denat., Caprylic/Capric Triglyceride, Diethylhexyl Syringylidenemalonate, Fragrance, Glycerin, Stearoxytrimethylsilane, Tocopherol.

  • QUESTIONS

    Questions?
    1-800-Wegmans(934-6267) Ext 5920
    9am - 4pm EST weekdays

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    KIDS SUNSCREEN SPF 50 
    avobenzone 3.0% homosalate 15.0% octisalate 5.0% octocrylene 10.0% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47124-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3.0   in 100 g
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate15.0   in 100 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5.0   in 100 g
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene10.0   in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248)  
    Glycerin (UNII: PDC6A3C0OX)  
    Stearoxytrimethylsilane (UNII: 9862TW94B2)  
    Tocopherol (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47124-116-10340 g in 1 CAN; Type 0: Not a Combination Product05/18/2018
    2NDC:47124-116-05170 g in 1 CAN; Type 0: Not a Combination Product05/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/18/2018
    Labeler - Wegman (059650069)
    Registrant - Product Quest Mfg, LLC (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135manufacture(47124-116) , label(47124-116)

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