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SHISEIDO

SHISEIDO AMERICA INC.

SHISEIDO URBAN ENVIRONMENT UV PROTECTION


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

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

SHISEIDO 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.

SHISEIDO 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 35•PA+++

For Face/Body

WATER-RESISTANT

SUNSCREEN

30mL NET WT. 1.1OZ.

SHISEIDO

SHISEIDO

Octinoxate, Octocrylene, and Zinc oxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52686-677
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 2.50047 g
OCTOCRYLENE Octocrylene 1.5309 g
Zinc Oxide Zinc oxide 3.41901 g

Inactive Ingredients

Ingredient Name Strength
cyclomethicone
water
ISODODECANE
BUTYLENE GLYCOL
DIMETHICONE
GLYCERIN
Xylitol
METHYL GLUCETH-10
THIOTAURINE
SCUTELLARIA BAICALENSIS ROOT
arginine hydrochloride
ONONIS CAMPESTRIS ROOT
ECTOINE
SODIUM PYRROLIDONE CARBOXYLATE
HYDROGENATED POLYDECENE (550 MW)
OXYBENZONE
isostearic acid
TRIETHOXYCAPRYLYLSILANE
EDETATE TRISODIUM
SILICON DIOXIDE
BUTYLATED HYDROXYTOLUENE
SYZYGIUM JAMBOS LEAF
ALPHA-TOCOPHEROL
PHENOXYETHANOL

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-03-01


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