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

SHISEIDO URBAN ENVIRONMENT by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:	Purpose
OCTINOXATE 4.9%	Sunscreen
OCTOCRYLENE 3.0%	Sunscreen
ZINC OXIDE 12.5%	Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive Ingredients

WATER, DIMETHICONE, ISODODECANE, SD ALCOHOL 40-B, DIPROPYLENE GLYCOL, ETHYLHEXYL PALMITATE, PEG-10 DIMETHICONE, 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, HYDROGEN DIMETHICONE, BUTYLENE GLYCOL, DISODIUM EDTA, DISTEARDIMONIUM HECTORITE, ALUMINA, BHT, TRIETHOXYCAPRYLYLSILANE, SYZYGIUM JAMBOS LEAF EXTRACT, TOCOPHEROL, PHENOXYETHANOL, BENZOIC ACID, FRAGRANCE, TITANIUM DIOXIDE, MICA,

Other information

• protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

SPL UNCLASSIFIED SECTION

SHISEIDO AMERICA INC. NEW YORK, N.Y. 10022
SHISEIDO DIST. NEW YORK PARIS MILANO

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

SHISEIDO
GINZA TOKYO

Urban Environment
Oil-Free UV Protector

42

BROAD SPECTRUM
SPF 42

For Face

WATER RESISTANT
(40 MINUTES)

SUNSCREEN

30mL 1 FL. OZ.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-346
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1557 mg  in 31.77 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	953 mg  in 31.77 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3971 mg  in 31.77 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
XYLITOL (UNII: VCQ006KQ1E)
THIOTAURINE (UNII: NQZ2D7AO62)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)
ECTOINE (UNII: 7GXZ3858RY)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-346-10	1 in 1 CARTON	10/01/2012
1		31.77 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 58411-346-80	2.12 g in 1 POUCH; Type 0: Not a Combination Product	10/01/2012
3	NDC: 58411-346-11	1 in 1 CARTON	10/01/2012
3		7.41 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	10/01/2012

Labeler - SHISEIDO AMERICA INC. (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(58411-346) , ANALYSIS(58411-346)