WKND UNDERWATER SUN TAN (TITANIUM DIOXIDE, OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE) STICK [SURFCODE]

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  • WKND UNDERWATER SUN TAN (TITANIUM DIOXIDE, OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE) STICK [SURFCODE]

WKND UNDERWATER SUN TAN (TITANIUM DIOXIDE, OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE) STICK [SURFCODE]
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NDC 71192-040-01, 71192-040-02
Set ID 22669de3-74c1-467d-96a1-5c67c35fa734
Category HUMAN OTC DRUG LABEL
Packager SURFCODE
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    Active ingredients: Titanium Dioxide 14.55%, Octocrylene 10.00%, Homosalate 10.00%, Ethylhexyl Salicylate 5.00%, Butyl Methoxydibenzoylmethane 3.00%

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Isopropyl Myristate, Triethyl Citrate , Ceresin, Talc, Methyl Methacrylate Crosspolymer, Euphorbia Cerifera (Candelilla) Wax, Cetyl Ethyhexanoate, CI 77492, Microcrystalline Wax, Polyethylene, Beeswax, Bis-EthylHexylOxyphenol Methoxyphenyl Triazine, CI 77491, Dimethicone, Silica Dimethyl Silylate , Ci 77499, Phenoxyethanol

  • PURPOSE

    Purpose: Sunscreen

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

  • DESCRIPTION

    USES:

    - Help prevent sunburn

    - Higher SPF gives more sunburn protection

    - Retains SPF after 180 minutes of activity in the water or sweating

    DIRECTION: Apply liberally and uniformly to all exposed areas before sun exposure.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    WKND UNDERWATER SUN TAN 
    titanium dioxide, octocrylene, homosalate, octisalate, avobenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71192-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide2.61 g  in 18 g
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene1.80 g  in 18 g
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate1.80 g  in 18 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.90 g  in 18 g
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone0.54 g  in 18 g
    Inactive Ingredients
    Ingredient NameStrength
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Ceresin (UNII: Q1LS2UJO3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71192-040-021 in 1 CARTON12/01/2017
    1NDC:71192-040-0118 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2017
    Labeler - SURFCODE (693717579)
    Registrant - SURFCODE (693717579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natuzen Co.,Ltd.688201272manufacture(71192-040)
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