WKND UNDERWATER SUN SCREEN 50ML (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) CREAM [SURFCODE]

WKND UNDERWATER SUN SCREEN 50ML (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE) CREAM [SURFCODE]
PDF | XML

NDC 71192-050-01, 71192-050-02
Set ID 751a944c-7d4d-42b3-8bed-4d4c916b3b52
Category HUMAN OTC DRUG LABEL
Packager SURFCODE
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient: ETHYLHEXYL METHOXYCINNAMATE 7.50%, ETHYLHEXYL SALICYLATE 5.00%, TITANIUM DIOXIDE 3.5%

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Butylene Glycol, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Isoamyl p-Methoxycinnamate, Niacinamide, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Glycerin, Sodium Chloride, Disteardimonium Hectorite, Polyglutamic Acid, Dimethicone Crosspolymer, Aluminum Stearate, Polyhydroxystearic Acid, Alumina, Dimethicone, Dimethiconol, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, 1,2-Hexanediol, Caprylyl Glycol, Dipotassium Glycyrrhizate, Salicornia Herbacea Extract, Phragmites Communis Extract, Adenosine, CI 77492, CI 77491

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

  • DESCRIPTION

    Direction: - Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure. Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

    Uses: - Helps prevent sunburn - Higher SPF gives more sunburn protection - Retains SPF after 80 minutes of activity in the water or sweating

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    WKND UNDERWATER SUN SCREEN  50ML
    octinoxate, octisalate, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71192-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 g  in 50 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.75 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Sorbitan Olivate (UNII: MDL271E3GR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71192-050-021 in 1 CARTON07/01/2018
    1NDC:71192-050-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/01/2018
    Labeler - SURFCODE (693717579)
    Registrant - SURFCODE (693717579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natuzen Co.,Ltd.688201272manufacture(71192-050)

Related Drugs