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

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.

----------

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

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71192-040
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.61 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

Ingredient Name	Strength
Inactive Ingredients
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Ceresin (UNII: Q1LS2UJO3A)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71192-040-02	1 in 1 CARTON	12/01/2017
1	NDC:71192-040-01	18 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/01/2017

Labeler - SURFCODE (693717579)

Registrant - SURFCODE (693717579)

Name	Address	ID/FEI	Business Operations
Establishment
Natuzen Co.,Ltd.		688201272	manufacture(71192-040)