SHISEIDO URBAN ENVIRONMENT UV PROTECTION- octinoxate, octocrylene, and zinc oxide cream
SHISEIDO AMERICA INC.

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GSC Urban Environment UV Protection Cream

Drug Facts

Active ingredients	Purpose
OCTINOXATE 4.9%	Sunscreen
OCTOCRYLENE 3.0%	Sunscreen
ZINC OXIDE 6.7%	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.

Other information

high sun protection product.
Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
Broad spectrum sunscreen; provides protection against UVA and UVB radiation.

Inactive Ingredients

WATER, ISODODECANE, BUTYLENE GLYCOL, DIMETHICONE, SD ALCOHOL 40-B, POLYMETHYL METHACRYLATE, CYCLOMETHICONE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, GLYCERIN, DISTEARDIMONIUM HECTORITE, XYLITOL, METHYL GLUCETH-10 , PEG/PPG-14/7 DIMETHYL ETHER, THIOTAURINE, SCUTELLARIA BAICALENSIS ROOT EXTRACT, ARGININE HCl, ONONIS SPINOSA ROOT EXTRACT, ECTOIN, SODIUM PCA, HYDROGENATED POLYDECENE, BENZOPHENONE-3 , ISOSTEARIC ACID, TRIETHOXYCAPRYLYLSILANE, TRISODIUM EDTA, SILICA, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, BHT, SYZYGIUM JAMBOS LEAF EXTRACT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE

Questions?

1-800-906-7503

PRINCIPAL DISPLAY PANEL - 50 mL Carton

SHISEIDO

Anti-Aging UV Care
UVA and UVB Protection

Urban Environment
UV Protection Cream

SPF 35 • PA+++

For Face/Body

WATER-RESISTANT

SUNSCREEN

50mL NET WT. 1.8 OZ.

SHISEIDO URBAN ENVIRONMENT UV PROTECTION
octinoxate, octocrylene, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52686-677
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	2.50047 g in 51.03 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	1.5309 g in 51.03 g
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z)	Zinc oxide	3.41901 g in 51.03 g

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
METHYL GLUCETH-10 (UNII: N0MWT4C7WH)
THIOTAURINE (UNII: NQZ2D7AO62)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
ARGININE Hydrochloride (UNII: F7LTH1E20Y)
ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)
ECTOINE (UNII: 7GXZ3858RY)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
OXYBENZONE (UNII: 95OOS7VE0Y)
ISOSTEARIC ACID (UNII: X33R8U0062)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE TRISODIUM (UNII: 420IP921MB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52686-677-60	1 in 1 CARTON	02/01/2011	09/14/2017
1		51.03 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M020	02/01/2011	09/14/2017

Labeler - SHISEIDO AMERICA INC. (782677132)

Name	Address	ID/FEI	Business Operations
Establishment
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(52686-677) , ANALYSIS(52686-677)

Revised: 12/2023

Document Id: 6f4b7a8d-35b6-4efc-86c3-38158f9edc3c

Set id: 2a395d11-c0bd-4401-8c03-665b7f809618

Version: 2

Effective Time: 20231228

SHISEIDO AMERICA INC.