SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR- octinoxate, octocrylene, and zinc oxide emulsion

SHISEIDO URBAN ENVIRONMENT by

Drug Labeling and Warnings

SHISEIDO URBAN ENVIRONMENT by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICA INC., Davlyn Industries Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
OCTINOXATE 7.4%	Sunscreen
OCTOCRYLENE 3.0%	Sunscreen
ZINC OXIDE 8.6%	Sunscreen

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection
• retains SPF after 40 minutes of perspiring

Warnings

For external use only

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply generously to face before sun exposure.
• children under 6 months of age: ask a doctor.

Inactive ingredients

WATER DIMETHICONE ISODODECANE SD ALCOHOL 40-B DIPROPYLENE GLYCOL ETHYLHEXYL PALMITATE GLYCERIN POLYMETHYLSILSESQUIOXANE VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER XYLITOL METHYL METHACRYLATE CROSSPOLYMER THIOTAURINE SCUTELLARIA BAICALENSIS ROOT EXTRACT PAEONIA ALBIFLORA ROOT EXTRACT ONONIS SPINOSA ROOT EXTRACT ECTOIN LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE TRIETHOXYCAPRYLYLSILANE BUTYLENE GLYCOL DISODIUM EDTA DISTEARDIMONIUM HECTORITE BHT SYZYGIUM JAMBOS LEAF EXTRACT TOCOPHEROL PHENOXYETHANOL BENZOIC ACID FRAGRANCE MICA TITANIUM DIOXIDE

Questions?

1-800-906-7503

SPL UNCLASSIFIED SECTION

SHISEIDO AMERICA INC. NEW YORK, N.Y. 10022

SHISEIDO DIST. NEW YORK PARIS MILANO

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

SHISEIDO

GINZA TOKYO

Urban Environment
Oil-Free UV Protector

42

BROAD SPECTRUM
SPF 42

For Face

WATER RESISTANT
(40 MINUTES)

SUNSCREEN

50mL 1.6 FL. OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO URBAN ENVIRONMENT   OIL-FREE UV PROTECTOR
octinoxate, octocrylene, and zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-350
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	2.27 g  in 30.66 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.92 g  in 30.66 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	2.64 g  in 30.66 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
XYLITOL (UNII: VCQ006KQ1E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
THIOTAURINE (UNII: NQZ2D7AO62)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
ECTOINE (UNII: 7GXZ3858RY)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BENZOIC ACID (UNII: 8SKN0B0MIM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-350-10	1 in 1 CARTON	02/01/2012
1		30.66 g in 1 BOTTLE, PLASTIC; 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	02/01/2012

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(58411-350) , ANALYSIS(58411-350)

Establishment
Name	Address	ID/FEI	Business Operations
Davlyn Industries Inc		624436254	MANUFACTURE(58411-350)