SUNSCREEN SPF 70 (AVOBENZONE 3% HOMOSALATE 15% OCTISALATE 5% OCTOCRYLENE 10%) SPRAY [WEGMAN]

SUNSCREEN SPF 70 (AVOBENZONE 3% HOMOSALATE 15% OCTISALATE 5% OCTOCRYLENE 10%) SPRAY [WEGMAN]
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NDC 47124-115-05
Set ID 01e932ee-e495-43aa-a70a-4b67ff4a742c
Category HUMAN OTC DRUG LABEL
Packager Wegman
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    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

  • WARNINGS

    Warnings
    Flammable: Do not use near heat, flame, or while smoking.
    For external use only
    Do not use on damaged or broken skin
    When using this product keep away from face to avoid breathing it • 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.
    Avoid spraying in eyes. • Contents under pressure. Do not puncture or
    incinerate. • Do not store at temperatures above 120ºF

  • KEEP OUT OF REACH OF CHILDREN

  • 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 • Children under 6 months: ask a doctor • 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-sleeve shirts,
    pants, hats, and sunglasses

  • OTHER SAFETY INFORMATION

    Other information • protect the product in this container from
    excessive heat and direct sun. • may stain some fabrics.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Acrylates/Octylacrylamide Copolymer,
    Alcohol Denat., Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Diethylhexyl
    Syringylidenemalonate, Fragrance, Glycerin

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN SPF 70 
    avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47124-115
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate15 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 g
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47124-115-05170 g in 1 CAN; Type 0: Not a Combination Product03/06/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/06/2013
    Labeler - Wegman (059650069)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(47124-115) , label(47124-115)

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