KIDS SPF 50 (AVOBENZONE 3% HOMOSALATE 10% OCTISALATE 5% OCTOCRYLENE 4% OXYBENZONE 5%) SPRAY [TOPCARE]

KIDS SPF 50 (AVOBENZONE 3% HOMOSALATE 10% OCTISALATE 5% OCTOCRYLENE 4% OXYBENZONE 5%) SPRAY [TOPCARE]
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NDC 36800-723-05, 36800-723-06
Set ID 298b2aa5-de4a-4507-a304-6e63dbb957f9
Category HUMAN OTC DRUG LABEL
Packager TopCare
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients                                                                                    Purpose
    Avobenzone 3%.......................................................................................Sunscreen
    Homosalate 10%.....................................................................................Sunscreen
    Octisalate 5%..........................................................................................Sunscreen
    Octocrylene 4%.......................................................................................Sunscreen
    Oxybenzone 5%.......................................................................................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
    moderate 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 out of eyes. Rinse with water to remove.
    Stop use and ask a doctor if • rash or irritation develops and last

    Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do
    not store at temperature above 120°F

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or
    contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions • Apply liberally 15 minutes before sun exposure and as needed.
    • Children under 6 months of age: ask a doctor. • 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. • 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. • For
    sunscreen use: • apply to all skin exposed to the sun. • Reapply as needed or after
    towel drying, swimming, or sweating.

  • OTHER SAFETY INFORMATION

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

  • INACTIVE INGREDIENT

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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    KIDS SPF 50 
    avobenzone 3% homosalate 10% octisalate 5% octocrylene 4% oxybenzone 5% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-723
    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) Homosalate10 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 g
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene4 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248)  
    Glycerin (UNII: PDC6A3C0OX)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Tocopherol (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-723-05170 g in 1 CAN; Type 0: Not a Combination Product02/15/2016
    2NDC:36800-723-06227 g in 1 CAN; Type 0: Not a Combination Product02/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/15/2016
    Labeler - TopCare (006935977)
    Registrant - Product Quest (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest927768135manufacture(36800-723) , label(36800-723)

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