Shiseido Urban Environment Fresh-moisture Sunscreen Cream
FDA Label NDC 58411-970

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shiseido Americas Corporation for the product Shiseido Urban Environment Fresh-moisture Sunscreen (NDC 58411-970). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

 Active Ingredients Purpose
 Avobenzone 2.3%Sunscreen    
 Homosalate 10% 
 Octisalate 5.0% 
 Octocrylene 5.0%

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

Otc - Do Not Use

Do not use ondamaged or broken skin

Otc - When Using

When using this productkeep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctorif rash occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply 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. - 2p.m.
  •    wear long-sleeve shirts, pant, hats, and sunglasses
  • children under 6 months: Ask a doctor

Inactive Ingredient

WATER･BUTYLENE GLYCOL･DIPROPYLENE GLYCOL･GLYCERIN･SD ALCOHOL 40-B･CAPRYLYL METHICONE･SILICA･GLYCERYL DIISOSTEARATE･PEG/PPG-14/7 DIMETHYL ETHER･BEHENETH-20･BEHENYL ALCOHOL･C30-45 ALKYL METHICONE･TREHALOSE･AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER･XANTHAN GUM･ASCORBYL TETRAISOPALMITATE･DIPOTASSIUM GLYCYRRHIZATE･SODIUM HYALURONATE･SANGUISORBA OFFICINALIS ROOT EXTRACT･CAMELLIA SINENSIS LEAF EXTRACT･GARCINIA MANGOSTANA BARK EXTRACT･PERILLA OCYMOIDES LEAF EXTRACT･SPIRULINA PLATENSIS EXTRACT･C30-45 OLEFIN･BIS-PEG-18 METHYL ETHER DIMETHYL SILANE･STEARYL ALCOHOL･DISODIUM EDTA･POTASSIUM HYDROXIDE･BHT･CARBOMER･ALCOHOL･SODIUM METABISULFITE･MICA･SYNTHETIC FLUORPHLOGOPITE･TOCOPHEROL･SODIUM CITRATE･PHENOXYETHANOL･CHLORPHENESIN･FRAGRANCE･TITANIUM DIOXIDE･

Questions Or Comments?

Call toll free 1-800-906-7503

Other Information

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

Principle Display Pannel 50 Ml Tube

SHISEIDO

GINZA TOKYO

Urban Environment

FRESH-MOISTURE

SUNSCREEN

SPF 40

Daily Protection & Age Defense

BROAD SPECTRUM SPF 40

50 mL NET WT.17 OZ.

* Please review the disclaimer below.