WKND UNDERWATER SUN WHITE- titanium dioxide, octocrylene, homosalate, octisalate, avobenzone stick

WKND UNDERWATER SUN WHITE by

Drug Labeling and Warnings

WKND UNDERWATER SUN WHITE 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 ingredients: Titanium Dioxide 24.25%, 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, Microcrystalline Wax, Polyethylene, Beeswax, Bis-EthylHexylOxyphenol Methoxyphenyl Triazine, Dimethicone, Silica Dimethyl Silylate, 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

INGREDIENTS AND APPEARANCE

WKND UNDERWATER SUN WHITE 
titanium dioxide, octocrylene, homosalate, octisalate, avobenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71192-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	4.36 g  in 18 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	1.80 g  in 18 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	1.80 g  in 18 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	0.90 g  in 18 g
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	0.54 g  in 18 g

Inactive Ingredients
Ingredient Name	Strength
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Triethyl Citrate (UNII: 8Z96QXD6UM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71192-030-02	1 in 1 CARTON	12/01/2017
1	NDC: 71192-030-01	18 g 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	12/01/2017

Labeler - SURFCODE (693717579)

Registrant - SURFCODE (693717579)

Establishment
Name	Address	ID/FEI	Business Operations
Natuzen Co.,Ltd.		688201272	manufacture(71192-030)