WKND UNDERWATER SUN SCREEN 50ML- octinoxate, octisalate, titanium dioxide cream

WKND UNDERWATER SUN SCREEN by

Drug Labeling and Warnings

WKND UNDERWATER SUN SCREEN by is a Otc medication manufactured, distributed, or labeled by SURFCODE, Natuzen Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

WKND UNDERWATER SUN SCREEN  50ML
octinoxate, octisalate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71192-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.75 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.75 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Butylene Glycol (UNII: 3XUS85K0RA)
Sorbitan Olivate (UNII: MDL271E3GR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71192-050-02	1 in 1 CARTON	07/01/2018
1	NDC: 71192-050-01	50 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2018

Labeler - SURFCODE (693717579)

Registrant - SURFCODE (693717579)

Establishment
Name	Address	ID/FEI	Business Operations
Natuzen Co.,Ltd.		688201272	manufacture(71192-050)