FDA.reportPublic FDA data

CLE DE PEAU BEAUTE

Manufacturer
SHISEIDO CO., LTD.
Effective date
2009-12-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:54:30

Label at a glance#

ProductCLE DE PEAU BEAUTE BF20
Active ingredientOctinoxate, Titanium dioxide
Label structure8 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

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
OCTINOXATE 1.9%Sunscreen
TITANIUM DIOAXIDE 15.0%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • higher SPF gives more sunburn protection

Warnings

WARNINGS SECTION

OTC - DO NOT USE 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 ingredients

INACTIVE INGREDIENT SECTION

TALC, SYNTHETIC FLUORPHLOGOPITE, BARIUM SULFATE, DIMETHICONE, TRIETHYLHEXANOIN, BIS-BEHENYL/PHYTOSTERYL DIMER DILINOLEATE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, SILICA, NYLON-12, SILICA DIMETHYL SILYLATE, TOCOPHERYL ACETATE, PRUNUS SPECIOSA LEAF EXTRACT, SODIUM ACETYLATED HYALURONATE, ROSA ROXBURGHII FRUIT EXTRACT CAMELLIA SINENSIS LEAF EXTRACT, SORBITAN SESQUIISOSTEARATE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, METHICONE, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE, SODIUM MAGNESIUM SILICATE, POLYSILICONE-2, GLYCERIN, TOCOPHEROL, WATER, BUTYLENE GLYCOL, ALCOHOL, BHT, CHLORPHENESIN, FRAGRANCE, MICA, ZINC OXIDE, IRON OXIDES

Questions ?

OTC - QUESTIONS SECTION

1-800-906-7503

PRINCIPAL DISPLAY PANEL - 11g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

powder foundation

SPF 21
sunscreen

11g NET WT. .38 OZ.

Principal Display Panel L - 11g Carton
Principal Display Panel L - 11g Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52685-300-302023-09-18C16284748780-1956f9ecf-c00f-621f-e053-dbdaa90a74adCle de peau Beaute Powder Foundation
52685-301-302023-09-18C16284748780-1956f9ecf-c00f-621f-e053-dbdaa90a74adCle de peau Beaute Powder Foundation
52685-302-302023-09-18C16284748780-1956f9ecf-c00f-621f-e053-dbdaa90a74adCle de peau Beaute Powder Foundation
52685-303-302023-09-18C16284748780-1956f9ecf-c00f-621f-e053-dbdaa90a74adCle de peau Beaute Powder Foundation
52685-304-302023-09-18C16284748780-1956f9ecf-c00f-621f-e053-dbdaa90a74adCle de peau Beaute Powder Foundation
52685-305-302023-09-18C16284748780-1956f9ecf-c00f-621f-e053-dbdaa90a74adCle de peau Beaute Powder Foundation
52685-306-302023-09-18C16284748780-1956f9ecf-c00f-621f-e053-dbdaa90a74adCle de peau Beaute Powder Foundation
52685-307-302023-09-18C16284748780-1956f9ecf-c00f-621f-e053-dbdaa90a74adCle de peau Beaute Powder Foundation
52685-300-302019-10-21C16284748780-1956f9ecf-c00f-621f-e053-dbdaa90a74adCle de peau Beaute Powder Foundation
52685-301-302019-10-21C16284748780-1956f9ecf-c00f-621f-e053-dbdaa90a74adCle de peau Beaute Powder Foundation
52685-302-302019-10-21C16284748780-1956f9ecf-c00f-621f-e053-dbdaa90a74adCle de peau Beaute Powder Foundation
52685-303-302019-10-21C16284748780-1956f9ecf-c00f-621f-e053-dbdaa90a74adCle de peau Beaute Powder Foundation
52685-304-302019-10-21C16284748780-1956f9ecf-c00f-621f-e053-dbdaa90a74adCle de peau Beaute Powder Foundation
52685-305-302019-10-21C16284748780-1956f9ecf-c00f-621f-e053-dbdaa90a74adCle de peau Beaute Powder Foundation
52685-306-302019-10-21C16284748780-1956f9ecf-c00f-621f-e053-dbdaa90a74adCle de peau Beaute Powder Foundation
52685-307-302019-10-21C16284748780-1956f9ecf-c00f-621f-e053-dbdaa90a74adCle de peau Beaute Powder Foundation

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
Titanium dioxideACTIVE INGREDIENT15FIX9V2JP1
OctinoxateACTIVE MOIETY4Y5P7MUD511
Titanium dioxideACTIVE MOIETY15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52685-30052685-300-30
52685-30152685-301-30
52685-30252685-302-30
52685-30352685-303-30
52685-30452685-304-30
52685-30552685-305-30
52685-30652685-306-30
52685-30752685-307-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octinoxate4Y5P7MUD51ACTIB
Titanium dioxide15FIX9V2JPACTIB
Octinoxate4Y5P7MUD51ACTIB
Titanium dioxide15FIX9V2JPACTIB
Octinoxate4Y5P7MUD51ACTIB
Titanium dioxide15FIX9V2JPACTIB
Octinoxate4Y5P7MUD51ACTIB
Titanium dioxide15FIX9V2JPACTIB
Octinoxate4Y5P7MUD51ACTIB
Titanium dioxide15FIX9V2JPACTIB
Octinoxate4Y5P7MUD51ACTIB
Titanium dioxide15FIX9V2JPACTIB
Octinoxate4Y5P7MUD51ACTIB
Titanium dioxide15FIX9V2JPACTIB
Octinoxate4Y5P7MUD51ACTIB
Titanium dioxide15FIX9V2JPACTIB

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
53e456d1-f878-4340-9c69-d56d609bfe1fde9cb841-19e2-48eb-a4a6-00ef46d35ce92023-09-15WarningsExact identifier
spl set id: de9cb841-19e2-48eb-a4a6-00ef46d35ce9

Reported adverse events (FAERS/openFDA)#

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