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Drug Facts
Shiseido Synchro Skin Self-refreshing Foundation 540 Mahogany Emulsion
FDA Label NDC 58411-511
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 Synchro Skin Self-refreshing Foundation 540 Mahogany (NDC 58411-511). 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
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Octinoxate 4.9% | Sunscreen |
| Titanium Dioxide 1% | 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.
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
- children under 6 months: ask a doctor
- 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
Inactive Ingredients
DIMETHICONE • WATER • GLYCERIN • TRIFLUOROPROPYLDIMETHYL/TRIMETHYLSILOXYSILICATE • PHENYL TRIMETHICONE • PEG-10 DIMETHICONE • BUTYLENE GLYCOL • DIMETHICONE CROSSPOLYMER • BIS-BUTYLDIMETHICONE POLYGLYCERYL-3 • SORBITAN SESQUIISOSTEARATE • ISOPROPYL MYRISTATE • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER • NACRE POWDER • MAGNESIUM ALUMINOMETASILICATE • POLYQUATERNIUM-51 • THYMUS SERPYLLUM EXTRACT • SODIUM ACETYLATED HYALURONATE • CYCLOPENTASILOXANE • DISTEARDIMONIUM HECTORITE • POLYSILICONE-2 • POLYMETHYLSILSESQUIOXANE • TRIMETHYLSILOXYSILYLCARBAMOYL PULLULAN • ALUMINUM HYDROXIDE • STEARIC ACID • LITHIUM MAGNESIUM SODIUM SILICATE • PEG/PPG-19/19 DIMETHICONE • CITRIC ACID • SODIUM CITRATE • BHT • SILICA • TOCOPHEROL • PHENOXYETHANOL • IRON OXIDES • TITANIUM DIOXIDE • MICA •
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 - 30 Ml Bottle Carton - 430 Cedar
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Foundation
Oil-Free
BROAD SPECTRUM
SPF 30
Sunscreen
30mL 1 FL. OZ.
Principal Display Panel (30 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Carton - 440 Amber
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Foundation
Oil-Free
BROAD SPECTRUM
SPF 30
Sunscreen
30mL 1 FL. OZ.
Principal Display Panel (30 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Carton - 450 Copper
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Foundation
Oil-Free
BROAD SPECTRUM
SPF 30
Sunscreen
30mL 1 FL. OZ.
Principal Display Panel (30 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Carton - 460 Topaz
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Foundation
Oil-Free
BROAD SPECTRUM
SPF 30
Sunscreen
30mL 1 FL. OZ.
Principal Display Panel (30 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Carton - 510 Suede
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Foundation
Oil-Free
BROAD SPECTRUM
SPF 30
Sunscreen
30mL 1 FL. OZ.
Principal Display Panel (30 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Carton - 520 Rosewood
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Foundation
Oil-Free
BROAD SPECTRUM
SPF 30
Sunscreen
30mL 1 FL. OZ.
Principal Display Panel (30 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Carton - 530 Henna
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Foundation
Oil-Free
BROAD SPECTRUM
SPF 30
Sunscreen
30mL 1 FL. OZ.
Principal Display Panel (30 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Carton - 540 Mahogany
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Foundation
Oil-Free
BROAD SPECTRUM
SPF 30
Sunscreen
30mL 1 FL. OZ.
Principal Display Panel (30 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Carton - 550 Jasper
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Foundation
Oil-Free
BROAD SPECTRUM
SPF 30
Sunscreen
30mL 1 FL. OZ.
Principal Display Panel (30 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Carton - 560 Obsidian
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Foundation
Oil-Free
BROAD SPECTRUM
SPF 30
Sunscreen
30mL 1 FL. OZ.
Principal Display Panel (30 mL Bottle Carton)
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