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Drug Facts
Cle De Peau Beaute The Foundation N
FDA Label NDC 58411-839
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 Cle De Peau Beaute The Foundation N (NDC 58411-839). 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 3.9% | Sunscreen |
| Titanium Dioxide 3.3% | 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
- 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
- children under 6 months: Ask a doctor
Inactive Ingredients
WATER▪DIMETHICONE▪BUTYLENE GLYCOL▪GLYCERIN▪CETYL ETHYLHEXANOATE▪CETYL PEG/PPG-10/1 DIMETHICONE▪NEOPENTYL GLYCOL DIHEPTANOATE▪DIPHENYLSILOXY PHENYL TRIMETHICONE▪TREHALOSE▪TOCOPHERYL ACETATE▪ARGANIA SPINOSA KERNEL OIL▪SODIUM HYALURONATE▪SODIUM DILAURAMIDOGLUTAMIDE LYSINE▪MAGNESIUM CHLORIDE▪PISTACIA LENTISCUS (MASTIC) GUM▪GLYCINE▪PEG/PPG-14/7 DIMETHYL ETHER▪BUPLEURUM FALCATUM ROOT EXTRACT▪ZANTHOXYLUM PIPERITUM PEEL EXTRACT▪THYMUS SERPYLLUM EXTRACT▪SODIUM ACETYLATED HYALURONATE▪ROSA ROXBURGHII FRUIT EXTRACT▪ANGELICA ACUTILOBA ROOT EXTRACT▪HYDROLYZED CONCHIOLIN PROTEIN▪HYDROLYZED SILK▪PERILLA OCYMOIDES LEAF EXTRACT▪DEXTRIN PALMITATE▪PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE▪ALUMINUM HYDROXIDE▪STEARIC ACID▪TRISODIUM EDTA▪HYDROXYPROPYLCELLULOSE▪PALMITIC ACID▪DIMETHYLACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE CROSSPOLYMER▪ALCOHOL▪DISTEARYLDIMONIUM CHLORIDE▪TRIETHOXYCAPRYLYLSILANE▪SYNTHETIC FLUORPHLOGOPITE▪BARIUM SULFATE▪CAPRYLIC/CAPRIC TRIGLYCERIDE▪ISOPROPYL ALCOHOL▪BHT▪SILICA▪THEANINE▪PHENOXYETHANOL▪CHLOROPHENESIN▪FRAGRANCE▪TITANIUM DIOXIDE▪IRON OXIDES▪
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 - 28 Ml Bottle Box - O50 Tan Ocher
clé de peau
B E A U T É
THE FOUNDATION N
BROAD SPECTRUM
SPF 22
SUNSCREEN
28mL NET WT. 1 OZ.
Principal Display Panel (28 mL Bottle Box)
Principal Display Panel - 28 Ml Bottle Box - I10 Very Light Ivory
clé de peau
B E A U T É
THE FOUNDATION N
BROAD SPECTRUM
SPF 22
SUNSCREEN
28mL NET WT. 1 OZ.
Principal Display Panel (28 mL Bottle Box)
Principal Display Panel - 28 Ml Bottle Box - O10 Light Ocher
clé de peau
B E A U T É
THE FOUNDATION N
BROAD SPECTRUM
SPF 22
SUNSCREEN
28mL NET WT. 1 OZ.
Principal Display Panel (28 mL Bottle Box)
Principal Display Panel - 28 Ml Bottle Box - O20 Light Medium Ocher
clé de peau
B E A U T É
THE FOUNDATION N
BROAD SPECTRUM
SPF 22
SUNSCREEN
28mL NET WT. 1 OZ.
Principal Display Panel (28 mL Bottle Box)
Principal Display Panel - 28 Ml Bottle Box - O30 Medium Ocher
clé de peau
B E A U T É
THE FOUNDATION N
BROAD SPECTRUM
SPF 22
SUNSCREEN
28mL NET WT. 1 OZ.
Principal Display Panel (28 mL Bottle Box)
Principal Display Panel - 28 Ml Bottle Box - O40 Light Tan Ocher
clé de peau
B E A U T É
THE FOUNDATION N
BROAD SPECTRUM
SPF 22
SUNSCREEN
28mL NET WT. 1 OZ.
Principal Display Panel (28 mL Bottle Box)
Principal Display Panel - 28 Ml Bottle Box - O60 Deep Tan Ocher
clé de peau
B E A U T É
THE FOUNDATION N
BROAD SPECTRUM
SPF 22
SUNSCREEN
28mL NET WT. 1 OZ.
Principal Display Panel (28 mL Bottle Box)
Principal Display Panel - 28 Ml Bottle Box - O80 Deep Ocher
clé de peau
B E A U T É
THE FOUNDATION N
BROAD SPECTRUM
SPF 22
SUNSCREEN
28mL NET WT. 1 OZ.
Principal Display Panel (28 mL Bottle Box)
Principal Display Panel - 28 Ml Bottle Box - O100 Rich Deep Ocher
clé de peau
B E A U T É
THE FOUNDATION N
BROAD SPECTRUM
SPF 22
SUNSCREEN
28mL NET WT. 1 OZ.
Principal Display Panel (28 mL Bottle Box)
Principal Display Panel - 28 Ml Bottle Box - B10 Light Beige
clé de peau
B E A U T É
THE FOUNDATION N
BROAD SPECTRUM
SPF 22
SUNSCREEN
28mL NET WT. 1 OZ.
Principal Display Panel (28 mL Bottle Box)
Principal Display Panel - 28 Ml Bottle Box - B20 Light Medium Beige
clé de peau
B E A U T É
THE FOUNDATION N
BROAD SPECTRUM
SPF 22
SUNSCREEN
28mL NET WT. 1 OZ.
Principal Display Panel (28 mL Bottle Box)
Principal Display Panel - 28 Ml Bottle Box - B30 Medium Beige
clé de peau
B E A U T É
THE FOUNDATION N
BROAD SPECTRUM
SPF 22
SUNSCREEN
28mL NET WT. 1 OZ.
Principal Display Panel (28 mL Bottle Box)
Principal Display Panel - 28 Ml Bottle Box - B40 Light Tan Beige
clé de peau
B E A U T É
THE FOUNDATION N
BROAD SPECTRUM
SPF 22
SUNSCREEN
28mL NET WT. 1 OZ.
Principal Display Panel (28 mL Bottle Box)
Principal Display Panel - 28 Ml Bottle Box - B50 Tan Beige
clé de peau
B E A U T É
THE FOUNDATION N
BROAD SPECTRUM
SPF 22
SUNSCREEN
28mL NET WT. 1 OZ.
Principal Display Panel (28 mL Bottle Box)
Principal Display Panel - 28 Ml Bottle Box - Bf10 Light Buff
clé de peau
B E A U T É
THE FOUNDATION N
BROAD SPECTRUM
SPF 22
SUNSCREEN
28mL NET WT. 1 OZ.
Principal Display Panel (28 mL Bottle Box)
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