ULTIMATE SHEER SUNSCREEN SPF 70 QUALITY CHOICE (AVOBENZONE 3.00% HOMOSALATE 15.00% OCTISALATE 5.00% OCTOCRYLENE 2.80% OXYBENZONE 6.00%) LOTION [QUALITY CHOICE]

ULTIMATE SHEER SUNSCREEN SPF 70 QUALITY CHOICE (AVOBENZONE 3.00% HOMOSALATE 15.00% OCTISALATE 5.00% OCTOCRYLENE 2.80% OXYBENZONE 6.00%) LOTION [QUALITY CHOICE]
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NDC 63868-781-04
Set ID 2ddfa23c-de49-4cb0-bb3e-5a6e66c845cc
Category HUMAN OTC DRUG LABEL
Packager Quality Choice
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients                                                                  Purpose
    Avobenzone 3.0%..................................................................Sunscreen
    Homosalate 15.0%.................................................................Sunscreen
    Octisalate 5.0%......................................................................Sunscreen
    Octocrylene 2.8%...................................................................Sunscreen
    Oxybenzone 6.0%..................................................................Sunscreen

  • PURPOSE

  • INDICATIONS & USAGE

    Uses • helps prevent 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
    • 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

  • OTHER SAFETY INFORMATION

    Other information • protect this product from excessive heat and
    direct sun • may stain fabrics

  • INACTIVE INGREDIENT

    Inactive ingredients

    Acrylates/C12-22 Alkyl Methacrylate
    Copolymer, Beeswax, BHT, Caprylyl Methicone, Cetyl Dimethicone,
    Dimethicone, Dimethyl Capramide, Dipotassium Glycyrrhizate, Disodium EDTA,
    Ethylhexyl Stearate, Ethylhexylglycerin, Fragrance,
    Glyceryl Stearate, Methylisothiazolinone, PEG-100
    Stearate, Polyaminopropyl Biguanide, Polyester-8, Silica,
    Sodium Polyacrylate, Styrene/Acrylates Copolymer,
    Trideceth-6, Trimethylsiloxysilicate, Water, Xanthan Gum

  • Questions? 248-449-9300

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ULTIMATE SHEER SUNSCREEN SPF 70  QUALITY CHOICE
    avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 2.80% oxybenzone 6.00% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-781
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 mL
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate15 g  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 mL
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene2.8 g  in 100 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Dimethyl Capramide (UNII: O29Y6X2JEZ)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Ethylhexyl Stearate (UNII: EG3PA2K3K5)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    Trideceth-6 (UNII: 3T5PCR2H0C)  
    Water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-781-04118 mL in 1 TUBE; Type 0: Not a Combination Product07/29/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/08/2015
    Labeler - Quality Choice (011920774)
    Registrant - Product Quest Mfg. (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg.927768135manufacture(63868-781) , label(63868-781)

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