SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42: Package Insert and Label Information

SHISEIDO URBAN ENVIRONMENT OIL-FREE SUNSCREEN SPF 42- ensulizole, homosalate, octisalate and zinc oxide emulsion
SHISEIDO AMERICAS CORPORATION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredients Purpose
ENSULIZOLE 1.0% Sunscreen
HOMOSALATE 15.0% Sunscreen
OCTISALATE 5.0% Sunscreen
ZINC OXIDE 15.5% 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.

Flammable: Do not use near heat, flame, or while smoking.

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▪TRISILOXANE▪SD ALCOHOL 40-B▪ZINC OXIDE▪GLYCERIN▪SILICA▪PEG/PPG-14/7 DIMETHYL ETHER▪LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE▪PEG-10 DIMETHICONE▪TREHALOSE▪MYRISTYL MYRISTATE▪ETHYLHEXYL PALMITATE▪DEXTRIN PALMITATE▪ISODECYL NEOPENTANOATE▪ASCORBYL TETRAISOPALMITATE▪THIOTAURINE▪DIPOTASSIUM GLYCYRRHIZATE▪SCUTELLARIA BAICALENSIS ROOT EXTRACT▪PAEONIA ALBIFLORA ROOT EXTRACT▪SODIUM HYALURONATE▪SANGUISORBA OFFICINALIS ROOT EXTRACT▪CAMELLIA SINENSIS LEAF EXTRACT▪GARCINIA MANGOSTANA BARK EXTRACT▪PERILLA OCYMOIDES LEAF EXTRACT▪SPIRULINA PLATENSIS EXTRACT▪TRIETHANOLAMINE▪TRIETHOXYCAPRYLYLSILANE▪BUTYLENE GLYCOL▪DISODIUM EDTA▪DISTEARDIMONIUM HECTORITE▪TOCOPHEROL▪BHT▪ALCOHOL▪ISOSTEARIC ACID▪MENTHOXYPROPANEDIOL▪SODIUM METABISULFITE▪POLYSILICONE-2▪BARIUM SULFATE▪SODIUM CITRATE▪PHENOXYETHANOL▪BENZOIC ACID▪FRAGRANCE▪IRON OXIDES ▪

Other information

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

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL — 30 mL Bottle Carton

SHISEIDO
GINZA TOKYO

Urban Environment

Sun Dual Care™

OIL-FREE
with HYALURONIC ACID

SPF
42

BROAD SPECTRUM SPF 42
WATER RESISTANT (40 MINUTES)
SUNSCREEN

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL -- 30 mL Bottle Carton
(click image for full-size original)
SHISEIDO URBAN ENVIRONMENT OIL-FREE SUNSCREEN SPF 42
ensulizole, homosalate, octisalate, and zinc oxide emulsion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-670
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE 0.4 g in 30 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 5.4 g in 30 mL
OCTISALATE (OCTISALATE) OCTISALATE 1.8 g in 30 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 5.6 g in 30 mL
Inactive Ingredients
Ingredient Name Strength
WATER
DIMETHICONE
TRISILOXANE
GLYCERIN
SILICON DIOXIDE
PEG/PPG-14/7 DIMETHYL ETHER
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
PEG-10 DIMETHICONE (600 CST)
TREHALOSE
MYRISTYL MYRISTATE
ETHYLHEXYL PALMITATE
DEXTRIN PALMITATE (CORN; 20000 MW)
ISODECYL NEOPENTANOATE
ASCORBYL TETRAISOPALMITATE
THIOTAURINE
GLYCYRRHIZINATE DIPOTASSIUM
SCUTELLARIA BAICALENSIS ROOT
PAEONIA LACTIFLORA ROOT
HYALURONATE SODIUM
SANGUISORBA OFFICINALIS ROOT
GREEN TEA LEAF
GARCINIA MANGOSTANA BARK
PERILLA FRUTESCENS LEAF
TROLAMINE
TRIETHOXYCAPRYLYLSILANE
BUTYLENE GLYCOL
EDETATE DISODIUM
DISTEARDIMONIUM HECTORITE
.ALPHA.-TOCOPHEROL
BUTYLATED HYDROXYTOLUENE
ALCOHOL
ISOSTEARIC ACID
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL
SODIUM METABISULFITE
BARIUM SULFATE
SODIUM CITRATE, UNSPECIFIED FORM
PHENOXYETHANOL
BENZOIC ACID
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58411-670-10 1 BOTTLE in 1 CARTON contains a BOTTLE
1 30 mL in 1 BOTTLE This package is contained within the CARTON (58411-670-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2022
Labeler — SHISEIDO AMERICAS CORPORATION (193691821)

Revised: 11/2021 SHISEIDO AMERICAS CORPORATION

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