KIDS SUNSCREEN SPF 50 (AVOBENZONE 3.00% HOMOSALATE 15.00% OCTISALATE 5.00% OCTOCRYLENE 10.00%) LOTION [WEGMAN]

KIDS SUNSCREEN SPF 50 (AVOBENZONE 3.00% HOMOSALATE 15.00% OCTISALATE 5.00% OCTOCRYLENE 10.00%) LOTION [WEGMAN]
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NDC 47124-112-05
Set ID 5205fcfb-069d-4745-8372-8fccb738cc58
Category HUMAN OTC DRUG LABEL
Packager Wegman
Generic Name
Product Class
Product Number
Application Number PART352
  • WARNINGS AND PRECAUTIONS

    Active ingredients                                                               Purpose
    Avobenzone 3%...................................................................Sunscreen
    Homosalate 15%.................................................................Sunscreen
    Octisalate 5%......................................................................Sunscreen
    Octocrylene 10%.................................................................Sunscreen

  • 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
    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

    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.
    • 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 SAFETY INFORMATION

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

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aluminum Starch Octenylsuccinate,
    Carbomer, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Fragrance,
    Phenoxyethanol, Polyglyceryl-3 Distearate, Sorbitan Isostearate,
    Sorbitol, Stearic Acid, Tocopherol, Triethanolamine,
    VP/Eicosene Copolymer, Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    KIDS SUNSCREEN SPF 50 
    avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 10.00% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47124-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 mL
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Homosalate (UNII: V06SV4M95S) 15 g  in 100 mL
    Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Polyglyceryl-3 Distearate (UNII: ZI1LK470XV)  
    Sorbitan Isostearate (UNII: 01S2G2C1E4)  
    Sorbitol (UNII: 506T60A25R)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47124-112-05177 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2013
    Labeler - Wegman (059650069)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(47124-112) , label(47124-112)

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