SHU UEMURA UV UNDERBASE SPF 20 SUNSCREEN- octinoxate titanium dioxide liquid

shu uemura UV underbase by

Drug Labeling and Warnings

shu uemura UV underbase by is a Otc medication manufactured, distributed, or labeled by Cosmelor Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

OCTINOXATE 3%; TITANIUM DIOXIDE 5.09%

Uses: Directions:

USES: Helps prevent sunburn.

DIRECTIONS: For sunscreen benefits, apply evenly before sun exposure.

Storage:

Please store at room temperature.

Warnings

WARNINGS: FOR EXTERNAL USE ONLY, NOT TO BE SWALLOWED. AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. DISCONTINUE USE IF SIGNS OF IRRITATION OR RASH APPEAR. IF IRRITATION OR RASH PERSISTS, CONSULT A DOCTOR. KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SHU UEMURA UV UNDERBASE  SPF 20 SUNSCREEN
octinoxate titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68570-704
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.84 mL  in 28 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	1.428 mL  in 28 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68570-704-01	1 in 1 CARTON
1		28 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2009

Labeler - Cosmelor Ltd (690725908)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmelor Ltd		690725908	manufacture