Shiseido Ultimate Sun Protector Cream
FDA Label NDC 58411-971

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 58411-971). 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
 Octisalate 3.0%Sunscreen   
 Octocrylene 3.0%
 Zinc Oxide 19.4%

Uses

  • helps prevent sunburn

Warnings

For external use only

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

Otc - Do Not Use

Do not useon damaged 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

  • 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. - 2p.m.
    • wear long-sleeve shirts, pant, hats, and sunglasses
    • children under 6 months: Ask a doctor

Inactive Ingredient

WATER･DIISOPROPYL SEBACATE･ISOPROPYL MYRISTATE･ALCOHOL DENAT.･PEG/PPG-9/2 DIMETHYL ETHER･GLYCERIN･ALCOHOL･PPG-3 DIPIVALATE･TALC･POLYGLYCERYL-6 POLYRICINOLEATE･SILICA･DEXTRIN PALMITATE･DEXTRIN PALMITATE/ETHYLHEXANOATE･ACRYLAMIDES/DMAPA ACRYLATES/METHOXY PEG METHACRYLATE COPOLYMER･DIPOTASSIUM GLYCYRRHIZATE･AMINOETHANESULFINIC ACID･PEG/PPG-14/7 DIMETHYL ETHER･SAXIFRAGA SARMENTOSA EXTRACT･CAMELLIA SINENSIS LEAF EXTRACT･EUCHEUMA SERRA/GRATELOUPIA SPARSA/SACCHARINA ANGUSTATA/ULVA LINZA/UNDARIA PINNATIFIDA EXTRACT･SODIUM HYALURONATE･SOPHORA ANGUSTIFOLIA ROOT EXTRACT･SACCHARINA ANGUSTATA/UNDARIA PINNATIFIDA EXTRACT･HYDROGEN DIMETHICONE･DIMETHYLACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE CROSSPOLYMER･HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER･SUCCINOGLYCAN･TOCOPHEROL･BHT･BUTYLENE GLYCOL･STEARIC ACID･SODIUM METABISULFITE･PEG-6･BIS-BUTYLDIMETHICONE POLYGLYCERYL-3･SYZYGIUM JAMBOS LEAF EXTRACT･CHLORPHENESIN･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- 50Ml Tube

SHISEIDO

GINZA TOKYO

Ultimate Sun Protector Cream

SPF 50

Advanced Protection & Age Defense

BROAD SPECTRUM SPF 50

WATER RESISTANT (80 MINUTES) 

SUNSCREEN

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