FDA.reportPublic FDA data

CLE DE PEAU BEAUTE UV PROTECTIVE TINTED

Manufacturer
SHISEIDO AMERICAS CORPORATION | SHISEIDO AMERICA INC.
Effective date
2018-12-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:57:39

Label at a glance#

ProductCLE DE PEAU BEAUTE UV PROTECTIVE TINTED IVORY
Active ingredientOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE
Label structure11 sections

Indications and 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

Dosage and administration

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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from ...

Storage and handling

protect this product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
OCTINOXATE 7.4%Sunscreen
OCTOCRYLENE 3.0%Sunscreen
TITANIUM DIOXIDE 4.6%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 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

INACTIVE INGREDIENT SECTION

WATER•DIPROPYLENE GLYCOL•DIMETHICONE•ISOPROPYL MYRISTATE•GLYCERIN•CYCLOPENTASILOXANE•SD ALCOHOL 40-B•LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•METHYL METHACRYLATE CROSSPOLYMER•DISTEARDIMONIUM HECTORITE•POLYMETHYLSILSESQUIOXANE•PEG/PPG-14/7 DIMETHYL ETHER•CETYL PEG/PPG-10/1 DIMETHICONE•SILICA•SORBITAN SESQUIISOSTEARATE•TREHALOSE•DEXTRIN PALMITATE•TOCOPHERYL ACETATE•POLYQUATERNIUM-51•SODIUM ACETYLATED HYALURONATE•DIPOTASSIUM GLYCYRRHIZATE•SAXIFRAGA SARMENTOSA EXTRACT•GINKGO BILOBA LEAF EXTRACT•THYMUS SERPYLLUM EXTRACT•HYDROLYZED SILK•2-O-ETHYL ASCORBIC ACID•SCUTELLARIA BAICALENSIS ROOT EXTRACT•UNCARIA GAMBIR EXTRACT•GARCINIA MANGOSTANA BARK EXTRACT•HIBISCUS SABDARIFFA FLOWER EXTRACT•PANAX GINSENG ROOT EXTRACT•BUPLEURUM FALCATUM ROOT EXTRACT•HYDROLYZED CONCHIOLIN PROTEIN•PPG-17•HYDRATED SILICA•TRIETHOXYCAPRYLYLSILANE•BUTYLENE GLYCOL•TRISODIUM EDTA•ALUMINUM HYDROXIDE•POLYSILICONE-2•ALCOHOL•DISTEARYLDIMONIUM CHLORIDE•BHT•TOCOPHEROL•SODIUM METABISULFITE•TALC•THEANINE•METHYLPARABEN•PHENOXYETHANOL•FRAGRANCE•TITANIUM DIOXIDE•IRON OXIDES•MICA•

Other information

STORAGE AND HANDLING SECTION

  • protect this product in this container from excessive heat and direct sun.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - IVORY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

50+

UV protective cream
tinted

BROAD SPECTRUM
SPF 50+
SUNSCREEN

30mL NET WT. 1.2 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - IVORY
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - IVORY

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - OCHER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

50+

UV protective cream
tinted

BROAD SPECTRUM
SPF 50+
SUNSCREEN

30mL NET WT. 1.2 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - OCHER
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - OCHER

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - DARK

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

50+

UV protective cream
tinted

BROAD SPECTRUM
SPF 50+
SUNSCREEN

30mL NET WT. 1.2 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - DARK
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - DARK

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58411-292-602025-01-30C16284748780-12cef2736-a193-d83d-e063-dadaa90ab31fCLÉ DE PEAU BEAUTÉ UV PROTECTIVE TINTED
58411-293-602025-01-30C16284748780-12cef2736-a193-d83d-e063-dadaa90ab31fCLÉ DE PEAU BEAUTÉ UV PROTECTIVE TINTED
58411-294-602025-01-30C16284748780-12cef2736-a193-d83d-e063-dadaa90ab31fCLÉ DE PEAU BEAUTÉ UV PROTECTIVE TINTED

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-292-60CLE DE PEAU BEAUTE UV PROTECTIVE TINTED IVORY30 mL in 1 TUBECREAM302
58411-292-60CLE DE PEAU BEAUTE UV PROTECTIVE TINTED IVORY1 in 1 CARTONCREAM12
58411-293-60CLE DE PEAU BEAUTE UV PROTECTIVE TINTED OCHER30 mL in 1 TUBECREAM302
58411-293-60CLE DE PEAU BEAUTE UV PROTECTIVE TINTED OCHER1 in 1 CARTONCREAM12
58411-294-60CLE DE PEAU BEAUTE UV PROTECTIVE TINTED DARK30 mL in 1 TUBECREAM302
58411-294-60CLE DE PEAU BEAUTE UV PROTECTIVE TINTED DARK1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-292CLE DE PEAU BEAUTE UV PROTECTIVE TINTED IVORY (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) CREAM CLE DE PEAU BEAUTE UV PROTECTIVE TINTED OCHER (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) CREAM CLE DE PEAU BEAUTE UV PROTECTIVE TINTED DARK (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) CREAM [SHISEIDO AMERICAS CORPORATION]2Legacy NDC, 2 package rows20181214_7d9598f1-cbee-4e87-a8f1-067e01fd8833.zip
58411-293CLE DE PEAU BEAUTE UV PROTECTIVE TINTED IVORY (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) CREAM CLE DE PEAU BEAUTE UV PROTECTIVE TINTED OCHER (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) CREAM CLE DE PEAU BEAUTE UV PROTECTIVE TINTED DARK (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) CREAM [SHISEIDO AMERICAS CORPORATION]2Legacy NDC, 2 package rows20181214_7d9598f1-cbee-4e87-a8f1-067e01fd8833.zip
58411-294CLE DE PEAU BEAUTE UV PROTECTIVE TINTED IVORY (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) CREAM CLE DE PEAU BEAUTE UV PROTECTIVE TINTED OCHER (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) CREAM CLE DE PEAU BEAUTE UV PROTECTIVE TINTED DARK (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) CREAM [SHISEIDO AMERICAS CORPORATION]2Legacy NDC, 2 package rows20181214_7d9598f1-cbee-4e87-a8f1-067e01fd8833.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 53 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-29258411-292-60
58411-29358411-293-60
58411-29458411-294-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 4 · 147 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIPROPYLENE GLYCOLE107L85C40IACT
DIMETHICONE92RU3N3Y1OIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
GLYCERINPDC6A3C0OXIACT
CYCLOMETHICONE 50THT5PCI0RIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
PEG/PPG-14/7 DIMETHYL ETHER6DNW9T7YT2IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TREHALOSEB8WCK70T7IIACT
DEXTRIN PALMITATE (CORN; 20000 MW)89B2BSF9I3IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)EL9825H96JIACT
SODIUM ACETYLATED HYALURONATEWN66R7GL93IACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
SAXIFRAGA STOLONIFERA LEAFO3TMV4903HIACT
GINKGO19FUJ2C58TIACT
THYMUS SERPYLLUM86H4S6K51NIACT
2-O-ETHYL ASCORBIC ACID801M14RK9KIACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
GARCINIA MANGOSTANA BARKN6A4WY566IIACT
HIBISCUS SABDARIFFA FLOWER45TGG6IU6MIACT
ASIAN GINSENGCUQ3A77YXIIACT
BUPLEURUM FALCATUM ROOTX04E310LUYIACT
PPG-17OV0Q322E0UIACT
HYDRATED SILICAY6O7T4G8P9IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
EDETATE TRISODIUM420IP921MBIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
ALCOHOL3K9958V90MIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
SODIUM METABISULFITE4VON5FNS3CIACT
TALC7SEV7J4R1UIACT
THEANINE8021PR16QOIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7cf25316-219a-29bc-e053-2a91aa0ab0497d9598f1-cbee-4e87-a8f1-067e01fd88332018-12-13WarningsExact identifier
spl id: 7cf25316-219a-29bc-e053-2a91aa0ab049
spl set id: 7d9598f1-cbee-4e87-a8f1-067e01fd8833

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.