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SHISEIDO

SHISEIDO AMERICA INC.

GSC Urban Environment UV Protection Cream


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 - 50 mL Carton

SHISEIDO

Anti-Aging UV Care
UVA and UVB Protection

35

Urban Environment
UV Protection Cream

SPF 35 • PA+++

For Face/Body

WATER-RESISTANT

SUNSCREEN

50mL NET WT. 1.8 OZ.

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
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 51.03 in 1 TUBE
2 NDC:52686-677-60 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2011-02-01


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