CLE DE PEAU BEAUTE FOUNDATION L BF20- titanium dioxide cream CLE DE PEAU BEAUTE FOUNDATION L I10- titanium dioxide cream CLE DE PEAU BEAUTE FOUNDATION L O10- titanium dioxide cream CLE DE PEAU BEAUTE FOUNDATION L O20- titanium dioxide cream CLE DE PEAU BEAUTE FOUNDATION L O30- titanium dioxide cream CLE DE PEAU BEAUTE FOUNDATION L B10- titanium dioxide cream CLE DE PEAU BEAUTE FOUNDATION L B20- titanium dioxide cream CLE DE PEAU BEAUTE FOUNDATION L B30- titanium dioxide cream

CLE DE PEAU BEAUTE FOUNDATION L by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE FOUNDATION L by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

TITANIUM DIOXIDE 2.1%

Purpose

Sunscreen

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

Warnings

For external use only

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs

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

Directions

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

WATER, CYCLOMETHICONE, TALC, BUTYLENE GLYCOL, NYLON-12, DIMETHICONE, GLYCERIN, PEG-10 DIMETHICONE, DEXTRIN PALMITATE, BARIUM SULFATE, POLYMETHYL METHACRYLATE, TOCOPHERYL ACETATE, GINKGO BILOBA LEAF EXTRACT, SODIUM ACETYLATED HYALURONATE, ROSA ROXBURGHII FRUIT EXTRACT, LILIUM CANDIDUM BULB EXTRACT, ALUMINUM HYDROXIDE, PALMITIC ACID, STEARIC ACID, TRISODIUM EDTA, DISTEARYLDIMONIUM CHLORIDE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, POLYSILICONE-2, ISOPROPYL ALCOHOL, SYNTHETIC FLUORPHLOGOPITE, TOCOPHEROL, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES, MICA,

Other information

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

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton BF20

clé de peau

BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton I10

clé de peau

BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton O10

clé de peau

BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton O20

clé de peau

BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton O30

clé de peau

BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton B10

clé de peau

BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton B20

clé de peau

BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton B30

clé de peau

BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE FOUNDATION L  BF20
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-145
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	656 mg  in 31.25 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
TALC (UNII: 7SEV7J4R1U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NYLON-12 (UNII: 446U8J075B)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GINKGO (UNII: 19FUJ2C58T)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-145-60	1 in 1 CARTON	02/01/2014
1		31.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2014

CLE DE PEAU BEAUTE FOUNDATION L  I10
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-146
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	656 mg  in 31.25 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
TALC (UNII: 7SEV7J4R1U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NYLON-12 (UNII: 446U8J075B)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GINKGO (UNII: 19FUJ2C58T)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-146-60	1 in 1 CARTON	02/01/2014
1		31.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2014

CLE DE PEAU BEAUTE FOUNDATION L  O10
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-147
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	656 mg  in 31.25 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
TALC (UNII: 7SEV7J4R1U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NYLON-12 (UNII: 446U8J075B)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GINKGO (UNII: 19FUJ2C58T)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-147-60	1 in 1 CARTON	02/01/2014
1		31.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2014

CLE DE PEAU BEAUTE FOUNDATION L  O20
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-148
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	656 mg  in 31.25 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
TALC (UNII: 7SEV7J4R1U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NYLON-12 (UNII: 446U8J075B)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GINKGO (UNII: 19FUJ2C58T)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-148-60	1 in 1 CARTON	02/01/2014
1		31.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2014

CLE DE PEAU BEAUTE FOUNDATION L  O30
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-149
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	656 mg  in 31.25 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
TALC (UNII: 7SEV7J4R1U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NYLON-12 (UNII: 446U8J075B)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GINKGO (UNII: 19FUJ2C58T)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-149-60	1 in 1 CARTON	02/01/2014
1		31.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2014

CLE DE PEAU BEAUTE FOUNDATION L  B10
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	656 mg  in 31.25 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
TALC (UNII: 7SEV7J4R1U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NYLON-12 (UNII: 446U8J075B)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GINKGO (UNII: 19FUJ2C58T)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-150-60	1 in 1 CARTON	02/01/2014
1		31.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2014

CLE DE PEAU BEAUTE FOUNDATION L  B20
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-151
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	656 mg  in 31.25 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
TALC (UNII: 7SEV7J4R1U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NYLON-12 (UNII: 446U8J075B)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GINKGO (UNII: 19FUJ2C58T)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-151-60	1 in 1 CARTON	02/01/2014
1		31.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2014

CLE DE PEAU BEAUTE FOUNDATION L  B30
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-152
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	656 mg  in 31.25 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
TALC (UNII: 7SEV7J4R1U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NYLON-12 (UNII: 446U8J075B)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GINKGO (UNII: 19FUJ2C58T)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-152-60	1 in 1 CARTON	02/01/2014
1		31.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2014

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-145, 58411-146, 58411-147, 58411-148, 58411-149, 58411-150, 58411-151, 58411-152) , analysis(58411-145, 58411-146, 58411-147, 58411-148, 58411-149, 58411-150, 58411-151, 58411-152)