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Drug Facts
Shiseido Synchro Skin Self-refreshing Tint Emulsion
FDA Label NDC 58411-673
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 Tint (NDC 58411-673). 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 4.7% | Sunscreen |
| Octocrylene 3.0% | Sunscreen |
| Titanium Dioxide 2.0% | 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
- 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 value 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
WATER•DIMETHICONE•GLYCERIN•TRIFLUOROPROPYLDIMETHYL/TRIMETHYLSILOXYSILICATE•CAPRYLYL METHICONE•BUTYLENE GLYCOL•DIMETHICONE/PEG-10/15 CROSSPOLYMER•SODIUM CHLORIDE•SYNTHETIC FLUORHLOGOPITE•SQUALANE•HYDROGENATED POLYISOBUTENE•THYMUS SERPYLLUM EXTRACT•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•POLYQUATERNIUM-51•SODIUM HYALURONATE•HYDROLYZED CONCHIOLIN PROTEIN•SORBITAN SESQUIISOSTEARATE•DISTEARDIMONIUM HECTORITE•PEG-10 DIMETHICONE•ALUMINUM HYDROXIDE•STEARIC ACID•TRISODIUM EDTA•HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER•LITHIUM MAGNESIUM SODIUM SILICATE•POLYSILICONE-2•SODIUM CITRATE•DIPROPYLENE GLYCOL•POLYSORBATE 60•ISODODECANE•PEG/PPG-19/19 DIMETHICONE•BHT•TOCOPHEROL•SORBITAN ISOSTEARATE•TRIMETHYLSILOXYSILYLCARBAMOYL PULLULAN•POLYMETHYLSILSESQUIOXANE•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 - 115 Fair Shirakaba
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Tint
BROAD SPECTRUM
SPF 20
Sunscreen
For Face
30mL NET WT. .95 OZ.
Principal Display Panel (30 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Carton - 125 Fair Asterid
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Tint
BROAD SPECTRUM
SPF 20
Sunscreen
For Face
30mL NET WT. .95 OZ.
Principal Display Panel (30 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Carton - 215 Light Buna
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Tint
BROAD SPECTRUM
SPF 20
Sunscreen
For Face
30mL NET WT. .95 OZ.
Principal Display Panel (30 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Carton - 225 Light Magnolia
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Tint
BROAD SPECTRUM
SPF 20
Sunscreen
For Face
30mL NET WT. .95 OZ.
Principal Display Panel (30 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Carton - 235 Light Hiba
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Tint
BROAD SPECTRUM
SPF 20
Sunscreen
For Face
30mL NET WT. .95 OZ.
Principal Display Panel (30 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Carton - 315 Medium Matsu
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Tint
BROAD SPECTRUM
SPF 20
Sunscreen
For Face
30mL NET WT. .95 OZ.
Principal Display Panel (30 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Carton - 325 Medium Keyaki
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Tint
BROAD SPECTRUM
SPF 20
Sunscreen
For Face
30mL NET WT. .95 OZ.
Principal Display Panel (30 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Carton - 335 Medium Katsura
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Tint
BROAD SPECTRUM
SPF 20
Sunscreen
For Face
30mL NET WT. .95 OZ.
Principal Display Panel (30 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Carton - 415 Tan Kwanzan
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Tint
BROAD SPECTRUM
SPF 20
Sunscreen
For Face
30mL NET WT. .95 OZ.
Principal Display Panel (30 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Carton - 425 Tan Ume
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Tint
BROAD SPECTRUM
SPF 20
Sunscreen
For Face
30mL NET WT. .95 OZ.
Principal Display Panel (30 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Carton - 515 Deep Tsubaki
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Tint
BROAD SPECTRUM
SPF 20
Sunscreen
For Face
30mL NET WT. .95 OZ.
Principal Display Panel (30 mL Bottle Carton)
Principal Display Panel - 30 Ml Bottle Carton - 525 Deep Kuromoji
SHISEIDO
GINZA TOKYO
SYNCHRO SKIN
SELF-REFRESHING
Tint
BROAD SPECTRUM
SPF 20
Sunscreen
For Face
30mL NET WT. .95 OZ.
Principal Display Panel (30 mL Bottle Carton)
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