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SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR

Dosage form: emulsion
Ingredients: Octinoxate 2.27g in 30.66g, Octocrylene 0.92g in 30.66g, Zinc Oxide 2.64g in 30.66g
Labeler: SHISEIDO AMERICA INC.
NDC Code: 52686-258

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.

SHISEIDO URBAN ENVIRONMENT OIL-FREE UV PROTECTOR

Drug Facts

Active ingredientsPurpose
OCTINOXATE 7.4%Sunscreen
OCTOCRYLENE 3.0%Sunscreen
ZINC OXIDE 8.6%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.

Inactive ingredients

WATER • DIMETHICONE • ISODODECANE • SD ALCOHOL 40-B • DIPROPYLENE GLYCOL • ETHYLHEXYL PALMITATE • GLYCERIN • POLYMETHYLSILSESQUIOXANE • VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER • POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER • XYLITOL • METHYL METHACRYLATE CROSSPOLYMER • THIOTAURINE • SCUTELLARIA BAICALENSIS ROOT EXTRACT • PAEONIA ALBIFLORA ROOT EXTRACT • ONONIS SPINOSA ROOT EXTRACT • ECTOIN • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • TRIETHOXYCAPRYLYLSILANE • BUTYLENE GLYCOL • DISODIUM EDTA • DISTEARDIMONIUM HECTORITE • BHT • SYZYGIUM JAMBOS LEAF EXTRACT • TOCOPHEROL • PHENOXYETHANOL • BENZOIC ACID • FRAGRANCE • MICA • TITANIUM DIOXIDE •

Questions?

1-800-906-7503

SHISEIDO AMERICA INC. NEW YORK, N.Y. 10022

SHISEIDO DIST. NEW YORK • PARIS • MILANO

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

SHISEIDO

Anti-Aging UV Care
UVA and UVB Protection

42

Urban Environment
Oil-Free UV Protector

SPF 42•PA+++

For Face

WATER•RESISTANT

SUNSCREEN

30mL NET WT. 1OZ.

SHISEIDO URBAN ENVIRONMENT   OIL-FREE UV PROTECTOR
octinoxate, octocrylene, and zinc oxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-258
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate2.27 g  in 30.66 g
Octocrylene (Octocrylene) Octocrylene0.92 g  in 30.66 g
Zinc Oxide (Zinc Oxide) Zinc Oxide2.64 g  in 30.66 g
Inactive Ingredients
Ingredient NameStrength
WATER 
DIMETHICONE 
ISODODECANE 
DIPROPYLENE GLYCOL 
ETHYLHEXYL PALMITATE 
GLYCERIN 
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) 
XYLITOL 
PHENOXYETHANOL 
TRIETHOXYCAPRYLYLSILANE 
BUTYLENE GLYCOL 
EDETATE DISODIUM 
THIOTAURINE 
BUTYLATED HYDROXYTOLUENE 
SCUTELLARIA BAICALENSIS ROOT 
MICA 
TITANIUM DIOXIDE 
PAEONIA LACTIFLORA ROOT 
ONONIS CAMPESTRIS ROOT 
SYZYGIUM JAMBOS LEAF 
ECTOINE 
ALPHA-TOCOPHEROL 
BENZOIC ACID 
Packaging
#Item CodePackage Description
1NDC:52686-258-101 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
130.66 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2012
Labeler - SHISEIDO AMERICA INC. (782677132)
Establishment
NameAddressID/FEIOperations
SHISEIDO AMERICA INC.782677132MANUFACTURE(52686-258), ANALYSIS(52686-258)
Establishment
NameAddressID/FEIOperations
Davlyn Industries Inc624436254MANUFACTURE(52686-258)

Revised: 01/2012
 
SHISEIDO AMERICA INC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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