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

SHISEIDO by

Drug Labeling and Warnings

SHISEIDO by is a Otc medication manufactured, distributed, or labeled by 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 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 - 30 mL Carton

SHISEIDO

Anti-Aging UV Care

SPF
35

Urban Environment
UV Protection Cream

SPF 35PA+++

For Face/Body

WATER-RESISTANT

SUNSCREEN

30mL NET WT. 1.1OZ.

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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 CAMPESTRIS ROOT (UNII: FD2FMC53M1)
ECTOINE (UNII: 7GXZ3858RY)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-677-61	1 in 1 CARTON
1		31.95 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	03/01/2012

Labeler - SHISEIDO AMERICA INC. (782677132)

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

Establishment
Name	Address	ID/FEI	Business Operations
Davlyn Industries Inc		624436254	MANUFACTURE(52686-677)