FDA.reportPublic FDA data

CLE DE PEAU BEAUTE CREAM COMPACT FOUNDATION

Manufacturer
SHISEIDO CO., LTD.
Effective date
2010-11-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:51:52

Label at a glance#

ProductCLE DE PEAU BEAUTE CREAM COMPACT FOUNDATION BF20
Active ingredientTitanium dioxide
Label structure9 sections

Indications and uses

helps prevent sunburn higher SPF gives more sunburn protection

Dosage and administration

apply evenly before sun exposure and as needed. children under 6 months of age: ask a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

TITANIUM DIOXIDE 15.8%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • higher SPF gives more sunburn protection

Warnings

WARNINGS SECTION

For external use only.

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 or irritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply evenly before sun exposure and as needed.
  • children under 6 months of age: ask a doctor.

Inactive Ingredient List

INACTIVE INGREDIENT SECTION

CYCLOMETHICONE, WATER, SYNTHETIC FLUORPHLOGOPITE, DIPROPYLENE GLYCOL, PARAFFIN, SORBITAN SESQUIISOSTEARATE, DIPHENYLSILOXY PHENYL TRIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PEG-10 DIMETHICONE, MICROCRYSTALLINE WAX, BARIUM SULFATE, EUPHORBIA CERIFERA (CANDELILLA) WAX, TOCOPHERYL ACETATE, ROSA ROXBURGHII FRUIT EXTRACT, SODIUM ACETYLATED HYALURONATE, CAMELLIA SINENSIS LEAF EXTRACT, BUPLEURUM FALCATUM ROOT EXTRACT, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, POLYSILICONE-2, CELLULOSE, DIMETHICONE, ALUMINA, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE, DISTEARYLDIMONIUM CHLORIDE, PALMITIC ACID, DIMETHICONE/METHICONE COPOLYMER, BUTYLENE GLYCOL, TOCOPHEROL, ISOPROPYL ALCOHOL, TRIETHOXYCAPRYLYLSILANE, ALCOHOL, GLYCERIN, TIN OXIDE, PHENOXYETHANOL, FRAGRANCE, IRON OXIDES, MICA

Questions?

OTC - QUESTIONS SECTION

1-800-906-7503

PRINCIPAL DISPLAY PANEL - 12g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

cream compact foundation

SPF 18
sunscreen

12g NET WT. .42 OZ.

Principal Display Panel - 12g Carton
Principal Display Panel - 12g Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52685-330-302023-09-19C16284748780-1960f7f55-d1c3-8e05-e053-dbdaa90a074aCLE DE PEAU BEAUTE Cream Compact Foundation
52685-331-302023-09-19C16284748780-1960f7f55-d1c3-8e05-e053-dbdaa90a074aCLE DE PEAU BEAUTE Cream Compact Foundation
52685-332-302023-09-19C16284748780-1960f7f55-d1c3-8e05-e053-dbdaa90a074aCLE DE PEAU BEAUTE Cream Compact Foundation
52685-333-302023-09-19C16284748780-1960f7f55-d1c3-8e05-e053-dbdaa90a074aCLE DE PEAU BEAUTE Cream Compact Foundation
52685-334-302023-09-19C16284748780-1960f7f55-d1c3-8e05-e053-dbdaa90a074aCLE DE PEAU BEAUTE Cream Compact Foundation
52685-335-302023-09-19C16284748780-1960f7f55-d1c3-8e05-e053-dbdaa90a074aCLE DE PEAU BEAUTE Cream Compact Foundation
52685-336-302023-09-19C16284748780-1960f7f55-d1c3-8e05-e053-dbdaa90a074aCLE DE PEAU BEAUTE Cream Compact Foundation
52685-337-302023-09-19C16284748780-1960f7f55-d1c3-8e05-e053-dbdaa90a074aCLE DE PEAU BEAUTE Cream Compact Foundation
52685-330-302019-10-29C16284748780-1960f7f55-d1c3-8e05-e053-dbdaa90a074aCLE DE PEAU BEAUTE Cream Compact Foundation
52685-331-302019-10-29C16284748780-1960f7f55-d1c3-8e05-e053-dbdaa90a074aCLE DE PEAU BEAUTE Cream Compact Foundation
52685-332-302019-10-29C16284748780-1960f7f55-d1c3-8e05-e053-dbdaa90a074aCLE DE PEAU BEAUTE Cream Compact Foundation
52685-333-302019-10-29C16284748780-1960f7f55-d1c3-8e05-e053-dbdaa90a074aCLE DE PEAU BEAUTE Cream Compact Foundation
52685-334-302019-10-29C16284748780-1960f7f55-d1c3-8e05-e053-dbdaa90a074aCLE DE PEAU BEAUTE Cream Compact Foundation
52685-335-302019-10-29C16284748780-1960f7f55-d1c3-8e05-e053-dbdaa90a074aCLE DE PEAU BEAUTE Cream Compact Foundation
52685-336-302019-10-29C16284748780-1960f7f55-d1c3-8e05-e053-dbdaa90a074aCLE DE PEAU BEAUTE Cream Compact Foundation
52685-337-302019-10-29C16284748780-1960f7f55-d1c3-8e05-e053-dbdaa90a074aCLE DE PEAU BEAUTE Cream Compact Foundation

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium dioxideACTIVE INGREDIENT15FIX9V2JP1
Titanium dioxideACTIVE MOIETY15FIX9V2JP1
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW81
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
ALPHA CELLULOSEINACTIVE INGREDIENTI355QGZ19A1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ11
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69331
BARIUM SULFATEINACTIVE INGREDIENT25BB7EKE2E1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX191
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994Z1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C401
DISTEARYLDIMONIUM CHLORIDEINACTIVE INGREDIENTOM9573ZX3X1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3571
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B01
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163021
MICAINACTIVE INGREDIENTV8A1AW08801
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KY1
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H11
PARAFFININACTIVE INGREDIENTI9O0E3H2ZE1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
STANNIC OXIDEINACTIVE INGREDIENTKM7N50LOS61
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52685-33052685-330-30
52685-33152685-331-30
52685-33252685-332-30
52685-33352685-333-30
52685-33452685-334-30
52685-33552685-335-30
52685-33652685-336-30
52685-33752685-337-30

Ingredients#

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

DailyMed ingredient rows page 1 of 6 · 216 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium dioxide15FIX9V2JPACTIB
CYCLOMETHICONENMQ347994ZIACT
WATER059QF0KO0RIACT
DIPROPYLENE GLYCOLE107L85C40IACT
PARAFFINI9O0E3H2ZEIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
BARIUM SULFATE25BB7EKE2EIACT
CANDELILLA WAXWL0328HX19IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ALPHA CELLULOSEI355QGZ19AIACT
DIMETHICONE92RU3N3Y1OIACT
ALUMINUM OXIDELMI26O6933IACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
PALMITIC ACID2V16EO95H1IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
ISOPROPYL ALCOHOLND2M416302IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
STANNIC OXIDEKM7N50LOS6IACT
PHENOXYETHANOLHIE492ZZ3TIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
MICAV8A1AW0880IACT
Titanium dioxide15FIX9V2JPACTIB
CYCLOMETHICONENMQ347994ZIACT
WATER059QF0KO0RIACT
DIPROPYLENE GLYCOLE107L85C40IACT
PARAFFINI9O0E3H2ZEIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
BARIUM SULFATE25BB7EKE2EIACT
CANDELILLA WAXWL0328HX19IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ALPHA CELLULOSEI355QGZ19AIACT
DIMETHICONE92RU3N3Y1OIACT
ALUMINUM OXIDELMI26O6933IACT

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 5 · 247 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, EXTENDED RELEASE / ORAL1.49 mgExact identifier — unii candidate
10 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, CHEWABLE / ORAL14 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
10 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECAPSULE, EXTENDED RELEASE / ORAL100 mgExact identifier — unii candidate
11 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii candidate
11 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE, DL-.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8OINTMENT / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933SPONGE / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
MICROCRYSTALLINE WAXMICROCRYSTALLINE WAXXOF597Q3KYGEL / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTGRANULE, FOR SUSPENSION / ORAL11 mgExact identifier — unii candidate
20 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / TRANSDERMAL296 mgExact identifier — unii candidate
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
PALMITIC ACIDPALMITIC ACID2V16EO95H1TABLET / ORAL6 mgExact identifier — unii candidate
2 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
20 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact 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
a417e091-200f-4a60-9f5b-1d7b6b3400deb45e0e88-1a20-4784-aae9-5b160eda8b082023-09-18WarningsExact identifier
spl set id: b45e0e88-1a20-4784-aae9-5b160eda8b08

Reported adverse events (FAERS/openFDA)#

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