Shiseido Ultimate Sun Protector Lotion
FDA Label NDC 58411-481

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 58411-481). 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
Avobenzone 2.3%Sunscreen
Homosalate 10.0%Sunscreen
Octocrylene 5.0%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▪DIISOPROPYL SEBACATE▪TALC▪METHYL METHACRYLATE CROSSPOLYMER▪DIMETHICONE▪PEG/PPG-9/2 DIMETHYL ETHER▪SD ALCOHOL 40-B▪LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE▪TRIETHYLHEXANOIN▪GLYCERIN▪DEXTRIN PALMITATE▪SUCROSE TETRASTEARATE TRIACETATE▪ISODODECANE▪PPG-3 DIPIVALATE▪TRIMETHYLSILOXYSILICATE▪SILICA▪SODIUM CHLORIDE▪PEG/PPG-14/7 DIMETHYL ETHER▪SAXIFRAGA SARMENTOSA EXTRACT▪CAMELLIA SINENSIS LEAF EXTRACT▪SOPHORA ANGUSTIFOLIA ROOT EXTRACT▪PPG-17▪DISTEARDIMONIUM HECTORITE▪CALCIUM STEARATE▪ISOSTEARIC ACID▪PALMITIC ACID▪TRISODIUM EDTA▪ALCOHOL▪SILICA DIMETHYL SILYLATE▪VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER▪PEG-6▪BHT▪TOCOPHEROL▪BUTYLENE GLYCOL▪STEARIC ACID▪SODIUM METABISULFITE▪SYZYGIUM JAMBOS LEAF EXTRACT▪POLYSILICONE-2▪METHYLPARABEN▪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 - 150 Ml Bottle Label

SHISEIDO
GINZA TOKYO

Ultimate
Sun Protector Lotion

50+

SynchroShield
WetForce x HeatForce

Turns Invisible

BROAD SPECTRUM
SPF 50+

For Face/Body

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

150mL 5 FL. OZ.

Principal Display Panel (150 mL Bottle Label)

Principal Display Panel (150 mL Bottle Label)

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