Shiseido Ultimate Sun Protector Cream
FDA Label NDC 58411-480

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 Ultimate Sun Protector (NDC 58411-480). 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
Octisalate 5.0%Sunscreen
Octocrylene 7.0%Sunscreen
Titanium Dioxide 3.8%Sunscreen
Zinc Oxide 19.4%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.

Flammable

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

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every two 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▪SD ALCOHOL 40-B▪ISOPROPYL MYRISTATE▪PEG/PPG-9/2 DIMETHYL ETHER▪METHYL METHACRYLATE CROSSPOLYMER▪LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE▪GLYCERIN▪ISOHEXADECANE▪POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER▪ISODODECANE▪TRIMETHYLSILOXYSILICATE▪DISTEARDIMONIUM HECTORITE▪DEXTRIN PALMITATE▪PEG/PPG-14/7 DIMETHYL ETHER▪SAXIFRAGA SARMENTOSA EXTRACT▪SCUTELLARIA BAICALENSIS ROOT EXTRACT▪CAMELLIA SINENSIS LEAF EXTRACT▪ONONIS SPINOSA ROOT EXTRACT▪SODIUM HYALURONATE▪SOPHORA ANGUSTIFOLIA ROOT EXTRACT▪ALUMINUM HYDROXIDE▪SILICA▪HYDROGEN DIMETHICONE▪STEARIC ACID▪SORBITAN SESQUIISOSTEARATE▪CARBOXYDECYL TRISILOXANE▪TRISODIUM EDTA▪BUTYLENE GLYCOL▪ALCOHOL▪POLYMETHYLSILSESQUIOXANE▪TALC▪TOCOPHEROL▪BHT▪SODIUM METABISULFITE▪PEG-6▪SYZYGIUM JAMBOS LEAF EXTRACT▪PHENOXYETHANOL▪FRAGRANCE▪

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 - 50 Ml Tube Label

SHISEIDO
GINZA TOKYO

Ultimate
Sun Protector Cream

50+

SynchroShield
WetForce × HeatForce

BROAD SPECTRUM
SPF 50+

For Face

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

50mL NET WT. 2 OZ.

Principal Display Panel (50 mL Tube Label)

Principal Display Panel (50 mL Tube Label)

* Please review the disclaimer below.