Shiseido Urban Environment Oil-free Mineral Sunscreen Spf 42 Emulsion
FDA Label NDC 58411-672

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 Oil-free Mineral Sunscreen Spf 42 (NDC 58411-672). 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 ingredientsPurpose
TITANIUM DIOXIDE 4.9%Sunscreen
ZINC OXIDE 13.6% 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

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

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

Otc - Stop Use

Stop use and ask a doctor if 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
  • 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

DIMETHICONE • WATER • SILICA • ZINC OXIDE • DIPROPYLENE GLYCOL • GLYCERIN • CAPRYLYL METHICONE • DIPHENYLSILOXY PHENYL TRIMETHICONE • ISODODECANE • HYDROGENATED POLYDECENE • PEG/PPG-14/7 DIMETHYL ETHER • PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • BIS-BUTYLDIMETHICONE POLYGLYCERYL-3 • PEG-10 DIMETHICONE • TREHALOSE • PHYTOSTERYL MACADAMIATE • ASCORBYL TETRAISOPALMITATE • THIOTAURINE • DIPOTASSIUM GLYCYRRHIZATE • SCUTELLARIA BAICALENSIS ROOT EXTRACT • PAEONIA ALBIFLORA ROOT EXTRACT • SODIUM HYALURONATE • SANGUISORBA OFFICINALIS ROOT EXTRACT • CAMELLIA SINENSIS LEAF EXTRACT • ONONIS SPINOSA ROOT EXTRACT • GARCINIA MANGOSTANA BARK EXTRACT • CURCUMA LONGA (TURMERIC) RHIZOME EXTRACT • PERILLA OCYMOIDES LEAF EXTRACT • SPIRULINA PLATENSIS EXTRACT • ALUMINUM HYDROXIDE • HYDROGEN DIMETHICONE • TRIETHOXYCAPRYLYLSILANE • BUTYLENE GLYCOL • ISOSTEARIC ACID • DISTEARDIMONIUM HECTORITE • TRISODIUM EDTA • SODIUM CITRATE • ALCOHOL • CITRIC ACID • SODIUM METABISULFITE • POLYSILICONE-2 • BARIUM SULFATE • SYZYGIUM JAMBOS LEAF EXTRACT • TOCOPHEROL • PHENOXYETHANOL • BENZOIC ACID • IRON OXIDES •

Other Information

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

Questions Or Comments?

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Principal Display Panel - 30 Ml Bottle Carton

SHISEIDO
GINZA TOKYO

Urban Environment

Sun Dual Care™

OIL-FREE
MINERAL
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)

Principal Display Panel (30 mL Bottle Carton)

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