Label: WKND UNDERWATER SUN TAN- titanium dioxide, octocrylene, homosalate, octisalate, avobenzone stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 23, 2019

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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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