Shiseido Ultimate Sun Protection S Lotion
FDA Label NDC 58411-924

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 Protection S (NDC 58411-924). 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 Factts

Otc - Purpose

Active IngredientsPurpose
TITANIUM DIOXIDE 9.1%Sunscreen
ZINC OXIDE 19.3% Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection mesaures (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 80 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 Ingredient

DIMETHICONE • WATER • BUTYLENE GLYCOL • GLYCERIN • DIISOPROPYL SEBACATE • POLYMETHYL METHACRYLATE • HYDROGENATED POLYDECENE • PEG-10 DIMETHICONE • CYCLOMETHICONE • PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • BIS-BUTYLDIMETHICONE POLYGLYCERYL-3 • PEG-6 • TRIMETHYLSILOXYSILICATE • PEG-32 • PEG/PPG-14/7 DIMETHYL ETHER • SCUTELLARIA BAICALENSIS ROOT EXTRACT • RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT • ALOE BARBADENSIS LEAF EXTRACT • THYMUS SERPILLUM EXTRACT • ALUMINUM DISTEARATE • ALUMINUM HYDROXIDE • HYDROGEN DIMETHICONE • ISOSTEARIC ACID • DISTEARDIMONIUM HECTORITE • HYDRATED SILICA • SODIUM METAPHOSPHATE • TRIETHOXYCAPRYLYLSILANE • STEARIC ACID • DEXTRIN PALMAITATE • DISTEARYLDIMONIUM CHLORIDE • TOCOPHEROL • SYZYGIUM JAMBOS LEAF EXTRACT •

Other Information

  • protect this product in this container from excessive heat and direct sun
  • avoid contact with clothing and other textiles - may stain

Questions Or Comments?

Call toll free 1-800-906-7503

* Please review the disclaimer below.