ULTIMATE SHEER SPF 70 (AVOBENZONE 3% HOMOSALATE 15% OCTISALATE 5% OCTOCRYLENE 10% OXYBENZONE 3%) STICK [TOP CARE]

ULTIMATE SHEER SPF 70 (AVOBENZONE 3% HOMOSALATE 15% OCTISALATE 5% OCTOCRYLENE 10% OXYBENZONE 3%) STICK [TOP CARE]
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NDC 36800-736-01
Set ID 775ac769-d1ab-4e0b-88a4-b64a2d805b11
Category HUMAN OTC DRUG LABEL
Packager Top Care
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredient                                     Purpose
    Avobenzone-3%
    Homosalate-15%                                      Sunscreen
    Octisalate-5%
    Octocrylene-10%
    Oxybenzone-3%

  • 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

    Remove cap and twist up tube.
    See important warnings under "When using this
    product" • 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,

    egularly 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 INGREDIENT

    Inactive ingredients Adipic Acid/Diglycol Crosspolymer, Beeswax,
    BHT, C12-15 Alkyl Benzoate, Caprylyl Glycol,
    Fragrance, Neopentyl Glycol Diethylhexanoate,
    Neopentyl Glycol Diisostearate, Octyldodecyl
    Neopentanoate, Ozokerite, Paraffin, Petrolatum,
    Polyester-8, Polyethylene, Silica.

  • QUESTIONS?

    1-888-423-0139

  • PRINCIPAL DISPLAY PANEL

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    ULTIMATE SHEER SPF 70 
    avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% oxybenzone 3% stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-736
    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
    Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
    Neopentyl Glycol Diisostearate (UNII: 4M6OQ34JWW)  
    Octyldodecyl Neopentanoate (UNII: X8725R883T)  
    CERESIN (UNII: Q1LS2UJO3A)  
    Paraffin (UNII: I9O0E3H2ZE)  
    Petrolatum (UNII: 4T6H12BN9U)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-736-0143 g in 1 PACKAGE; Type 0: Not a Combination Product02/23/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/23/2016
    Labeler - Top Care (006935977)
    Registrant - Product Quiest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quiest Mfg927768135manufacture(36800-736) , label(36800-736)

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