FDA Label for Shiseido Ultimate Sun Protector

View Indications, Usage & Precautions

Shiseido Ultimate Sun Protector Product Label

The following document was submitted to the FDA by the labeler of this product Shiseido Americas Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


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