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Drug Facts
SHISEIDO AMERICA INC.
NEW YORK, N.Y. 10022
SHISEIDO DIST.
NEW YORK • PARIS • MILANO
Shiseido Urban Environment Tinted Uv Protector
FDA Label NDC 52686-340
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 America Inc. for the product Shiseido Urban Environment Tinted Uv Protector (NDC 52686-340). 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, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, directions, 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 |
|---|---|
| ENSULIZOLE 2.0% | Sunscreen |
| OCTINOXATE 7.4% | Sunscreen |
| TITANIUM DIOXIDE 7.2% | 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
Otc - Do Not Use
For external use only
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
- reapply:
- after 40 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. – 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, PENTAERYTHRITYL TETRAETHYLHEXANOATE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, POLYMETHYL METHACRYLATE, GLYCERIN, DIPROPYLENE GLYCOL, DISTEARDIMONIUM HECTORITE, HYDROGENATED POLYDECENE, TRIMETHYLSILOXYSILICATE, SILICA, XYLITOL, PEG-6, PEG-32, PEG/PPG-14/7 DIMETHYL ETHER, THIOTAURINE, SAXIFRAGA SARMENTOSA EXTRACT, ARGININE HCl, ONONIS SPINOSA ROOT EXTRACT, SODIUM PCA, SOPHORA ANGUSTIFOLIA ROOT EXTRACT, PPG-17, ALUMINUM HYDROXIDE, AMINOMETHYL PROPANOL, ALUMINUM DISTEARATE, ISOSTEARIC ACID, STEARIC ACID, TRISODIUM EDTA, POLYMETHYLSILSESQUIOXANE, TALC, BUTYLENE GLYCOL, ALCOHOL, ALUMINA, POLYSILICONE-2, TRIETHOXYCAPRYLYLSILANE, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, BHT, SYZYGIUM JAMBOS LEAF EXTRACT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, IRON OXIDES, TITANIUM DIOXIDE,
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 - 30Ml Tube Carton
SHISEIDO
1
Anti-Aging
UV Care
43
Urban Environment
Tinted UV Protector
BROAD SPECTRUM
SPF 43
For Face
OIL-FREE
WATER RESISTANT
(40 MINUTES)
SUNSCREEN
30mL NET WT. 1.1OZ.
Principal Display Panel (30mL Tube Carton)
SHISEIDO
2
Anti-Aging
UV Care
43
Urban Environment
Tinted UV Protector
BROAD SPECTRUM
SPF 43
For Face
OIL-FREE
WATER RESISTANT
(40 MINUTES)
SUNSCREEN
30mL NET WT. 1.1OZ.
Principal Display Panel (30mL Tube Carton)
SHISEIDO
3
Anti-Aging
UV Care
43
Urban Environment
Tinted UV Protector
BROAD SPECTRUM
SPF 43
For Face
OIL-FREE
WATER RESISTANT
(40 MINUTES)
SUNSCREEN
30mL NET WT. 1.1OZ.
Principal Display Panel (30mL Tube Carton)
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