CLE DE PEAU BEAUTE BF20- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE I10- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE O10- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE O20- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE O30- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE B10- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE B20- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE B30- octinoxate and titanium dioxide powder

CLE DE PEAU BEAUTE by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE by is a Otc medication manufactured, distributed, or labeled by SHISEIDO CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
OCTINOXATE 1.9%	Sunscreen
TITANIUM DIOAXIDE 15.0%	Sunscreen

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection

Warnings

For external use only

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• rash or irritation develops and lasts.

Keep out of reach of children.

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

Directions

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

Inactive ingredients

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 ?

1-800-906-7503

PRINCIPAL DISPLAY PANEL - 11g Carton

clé de peau
BEAUTÉ

powder foundation

SPF 21
sunscreen

11g NET WT. .38 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE  BF20
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	209 mg  in 11 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	1.65 g  in 11 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-300-30	1 in 1 CARTON
1		11 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2009

CLE DE PEAU BEAUTE  I10
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	209 mg  in 11 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	1.65 g  in 11 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-301-30	1 in 1 CARTON
1		11 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2009

CLE DE PEAU BEAUTE  O10
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	209 mg  in 11 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	1.65 g  in 11 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-302-30	1 in 1 CARTON
1		11 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2009

CLE DE PEAU BEAUTE  O20
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	209 mg  in 11 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	1.65 g  in 11 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-303-30	1 in 1 CARTON
1		11 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2009

CLE DE PEAU BEAUTE  O30
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-304
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	209 mg  in 11 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	1.65 g  in 11 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-304-30	1 in 1 CARTON
1		11 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2009

CLE DE PEAU BEAUTE  B10
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-305
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	209 mg  in 11 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	1.65 g  in 11 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-305-30	1 in 1 CARTON
1		11 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2009

CLE DE PEAU BEAUTE  B20
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-306
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	209 mg  in 11 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	1.65 g  in 11 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-306-30	1 in 1 CARTON
1		11 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2009

CLE DE PEAU BEAUTE  B30
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-307
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	209 mg  in 11 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	1.65 g  in 11 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-307-30	1 in 1 CARTON
1		11 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2009

Labeler - SHISEIDO CO., LTD. (690536453)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO CO., LTD.		690536453	Manufacture