Shiseido Ultimate Sun Protector Mineral Lotion
FDA Label NDC 58411-903

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 Mineral (NDC 58411-903). 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 5.7%Sunscreen
ZINC OXIDE 5.9%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 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

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply 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

WATER･DIPHENYLSILOXY PHENYL TRIMETHICONE･DIMETHICONE･CETYL ETHYLHEXANOATE･TRISILOXANE･DIPROPYLENE GLYCOL･GLYCERIN･BUTYLOCTYL SALICYLATE･BIS-BUTYLDIMETHICONE POLYGLYCERYL-3･SILICA･PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE･PEG-10 DIMETHICONE･DEXTRIN PALMITATE･MYRISTYL MYRISTATE･PHENETHYL BENZOATE･PEG/PPG-14/7 DIMETHYL ETHER･DIPOTASSIUM GLYCYRRHIZATE･SCUTELLARIA BAICALENSIS ROOT EXTRACT･HIBISCUS SABDARIFFA FLOWER EXTRACT･CITRUS DEPRESSA PEEL EXTRACT･RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT･HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF EXTRACT･ALOE BARBADENSIS LEAF EXTRACT･THYMUS SERPYLLUM EXTRACT･EUCHEUMA SERRA/GRATELOUPIA SPARSA/SACCHARINA ANGUSTATA/ULVA LINZA/UNDARIA PINNATIFIDA EXTRACT･SACCHARINA ANGUSTATA/UNDARIA PINNATIFIDA EXTRACT･ALUMINUM HYDROXIDE･BUTYLENE GLYCOL･DISTEARDIMONIUM HECTORITE･HYDROGEN DIMETHICONE･ISOSTEARIC ACID･TRISODIUM EDTA･CALOPHYLLUM INOPHYLLUM SEED OIL･TRIETHOXYCAPRYLYLSILANE･SODIUM CITRATE･CITRIC ACID･STEARIC ACID･SODIUM METABISULFITE･GLUCOSYLRUTIN･SYZYGIUM JAMBOS LEAF EXTRACT･TOCOPHEROL･PHENOXYETHANOL･

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 Container Carton

SHISEIDO
GINZA TOKYO

Ultimate Sun Protector
Lotion MINERAL

SPF
60+

Advanced Protection & Age Defense

BROAD SPECTRUM SPF 60+
WATER RESISTANT (80 MINUTES)
SUNSCREEN

For All Skin Types Including Sensitive

150mL 5 FL. OZ.

Principal Display Panel (150 mL Container Carton)

Principal Display Panel (150 mL Container Carton)

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