FDA.reportPublic FDA data

CLÉ DE PEAU BEAUTÉ CORRECTING CREAM VEIL

Manufacturer
SHISEIDO AMERICAS CORPORATION | SHISEIDO AMERICA INC.
Effective date
2018-12-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:42:29

Label at a glance#

ProductCLE DE PEAU BEAUTE CORRECTING VEIL
Active ingredientENSULIZOLE, OCTINOXATE, TITANIUM DIOXIDE
Label structure8 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

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

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
ENSULIZOLE 1.0%Sunscreen
OCTINOXATE 2.9%Sunscreen
TITANIUM DIOXIDE 2.4%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 - STOP USE 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

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 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∙DIMETHICONE∙BUTYLENE GLYCOL∙GLYCERIN∙ISOHEXADECANE∙SD ALCOHOL 40-B∙POLYMETHYLSILSESQUIOXANE∙PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙NYLON-12∙TRIISOSTEARIN∙DISTEARDIMONIUM HECTORITE∙ERYTHRITOL∙CETYL ETHYLHEXANOATE∙XYLITOL∙SILICA∙ISODECYL NEOPENTANOATE∙TRIMETHYLSILOXYSILICATE∙SODIUM ACETYLATED HYALURONATE∙ROSA ROXBURGHII FRUIT EXTRACT∙DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER∙HYDROLYZED CONCHIOLIN PROTEIN∙HYDROLYZED SILK∙TRIETHANOLAMINE∙ISOSTEARIC ACID∙ALUMINUM DISTEARATE∙ALUMINUM HYDROXIDE∙DISODIUM EDTA∙ALUMINA∙BHT∙TRIETHOXYCAPRYLYLSILANE∙TOCOPHEROL∙POLYSILICONE-2∙ALCOHOL∙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 - 36 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau

BEAUTÉ

correcting cream veil

BROAD SPECTRUM SPF 21
SUNSCREEN

36mL NET WT. 1.4 OZ.

PRINCIPAL DISPLAY PANEL - 36 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 36 mL Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58411-205-602023-12-28C16284748780-1ba0f9c33-0f0a-a910-e053-dadaa90a0b85CLÉ DE PEAU BEAUTÉ CORRECTING CREAM VEIL
58411-205-602021-01-29C16284748780-1ba0f9c33-0f0a-a910-e053-dadaa90a0b85CLÉ DE PEAU BEAUTÉ CORRECTING CREAM VEIL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ENSULIZOLEACTIVE INGREDIENT9YQ9DI1W421
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
ENSULIZOLEACTIVE MOIETY9YQ9DI1W421
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ11
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
ALUMINUM DISTEARATEINACTIVE INGREDIENT7P1HP1B9UI1
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN01
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69331
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CETYL ETHYLHEXANOATEINACTIVE INGREDIENT134647WMX41
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DISTEARDIMONIUM HECTORITEINACTIVE INGREDIENTX687XDK09L1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
ERYTHRITOLINACTIVE INGREDIENTRA96B954X61
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
ISODECYL NEOPENTANOATEINACTIVE INGREDIENTW60VYE24XC1
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1E1
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U00621
MICAINACTIVE INGREDIENTV8A1AW08801
NYLON-12INACTIVE INGREDIENT446U8J075B1
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONEINACTIVE INGREDIENTTYP81E471F1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)INACTIVE INGREDIENT59Z907ZB691
ROSA ROXBURGHII FRUITINACTIVE INGREDIENTCVT1AA87FF1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM ACETYLATED HYALURONATEINACTIVE INGREDIENTWN66R7GL931
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E1
TRIISOSTEARININACTIVE INGREDIENT71503RH8KG1
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)INACTIVE INGREDIENT5041RX63GN1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E1

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58411-20558411-205-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERINPDC6A3C0OXIACT
ISOHEXADECANE918X1OUF1EIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
NYLON-12446U8J075BIACT
TRIISOSTEARIN71503RH8KGIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ERYTHRITOLRA96B954X6IACT
CETYL ETHYLHEXANOATE134647WMX4IACT
XYLITOLVCQ006KQ1EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ISODECYL NEOPENTANOATEW60VYE24XCIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
SODIUM ACETYLATED HYALURONATEWN66R7GL93IACT
ROSA ROXBURGHII FRUITCVT1AA87FFIACT
TROLAMINE9O3K93S3TKIACT
ISOSTEARIC ACIDX33R8U0062IACT
ALUMINUM DISTEARATE7P1HP1B9UIIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
EDETATE DISODIUM7FLD91C86KIACT
ALUMINUM OXIDELMI26O6933IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
ALCOHOL3K9958V90MIACT
PHENOXYETHANOLHIE492ZZ3TIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
MICAV8A1AW0880IACT
ENSULIZOLE9YQ9DI1W42ACTIB
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 394 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, EXTENDED RELEASE / TRANSDERMAL49 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TRANSDERMAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTFILM / BUCCAL0.27 mgExact identifier — unii candidate
20 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EPOWDER, FOR SUSPENSION / ORAL4223 mgExact identifier — unii candidate
12 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / NASAL20 mgExact identifier — unii candidate
49 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii candidate
77 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED PELLETS / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSPRAY, METERED / NASAL0.1 mg/1mlExact identifier — unii candidate
32 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSPONGE / TOPICAL11 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE / ORAL1190 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KELIXIR / ORAL1.3 mg/5mlExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, EXTENDED RELEASE / ORAL5 mgExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, DELAYED RELEASE / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / OPHTHALMIC0.06 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KGEL, METERED / TOPICAL4 mgExact identifier — unii candidate
32 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / BUCCAL0.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAVENOUS7 mgExact identifier — unii candidate
77 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
77 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / RECTAL97 mgExact identifier — unii candidate
77 equally ranked IID candidates
ISOSTEARIC ACIDISOSTEARIC ACIDX33R8U0062OINTMENT / TOPICALNAExact identifier — unii candidate
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET / SUBLINGUAL1 mgExact identifier — unii candidate
20 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, EFFERVESCENT / ORAL32 mgExact identifier — unii candidate
77 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SOLUTION / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SOLUTION / ORAL280 mgExact identifier — unii candidate
49 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii candidate
21 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KLOTION / TOPICAL1000 mgExact identifier — unii candidate
32 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / INTRAVENOUS0.03 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
20 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / RESPIRATORY (INHALATION)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
49 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
ab16f702-06a0-418c-802e-560392ce4f890710e240-c8cd-4446-be97-53139b13388f2023-12-28WarningsExact identifier
spl set id: 0710e240-c8cd-4446-be97-53139b13388f

Reported adverse events (FAERS/openFDA)#

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