SUNSCREEN SPF 50 (AVOBENZONE 3% HOMOSALATE 13% OCTISALATE 5% OCTOCRYLENE 7% OXYBENZONE 4%) LOTION [QUALITY CHOICE]

SUNSCREEN SPF 50 (AVOBENZONE 3% HOMOSALATE 13% OCTISALATE 5% OCTOCRYLENE 7% OXYBENZONE 4%) LOTION [QUALITY CHOICE]
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NDC 63868-786-06
Set ID dbc5d8c1-07ac-475e-b651-5f2d93131f40
Category HUMAN OTC DRUG LABEL
Packager Quality Choice
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    3% Avobenzone

    13% Homosalate

    5% Octisalate

    7% Octocrylene

    4% Oxybenzone

  • Purpose

    Sunscreen

  • Uses

    •  helps prevent sunburn • If used as directed with other
      sun protection measures (see Directions), decreases the risk of
      skin cancer and early skin aging caused by 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 product is 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 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 Ingredients

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

  • Other Information

    • protect this product from excessive heat and direct sun
    • may stain fabrics
  • Questions? 248-449-9300

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN SPF 50 
    avobenzone 3% homosalate 13% octisalate 5% octocrylene 7% oxybenzone 4% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-786
    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) HOMOSALATE13 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    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:63868-786-06227 g in 1 BOTTLE; Type 0: Not a Combination Product04/11/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/11/2014
    Labeler - Quality Choice (011920774)
    Registrant - Product Quest Mfg, LLC (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135manufacture(63868-786) , label(63868-786)

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