DailyMed - CLE DE PEAU BEAUTE RADIANT FOUNDATION I10- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE RADIANT FOUNDATION O10- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE RADIANT FOUNDATION O20- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE RADIANT FOUNDATION O30- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE RADIANT FOUNDATION O40- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE RADIANT FOUNDATION O50- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE RADIANT FOUNDATION O60- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE RADIANT FOUNDATION B10- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE RADIANT FOUNDATION B20- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE RADIANT FOUNDATION B30- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE RADIANT FOUNDATION BF20- octinoxate and titanium dioxide powder CLE DE PEAU BEAUTE RADIANT FOUNDATION WB20- octinoxate and titanium dioxide powder

NDC Code(s): 58411-241-30, 58411-242-30, 58411-243-30, 58411-244-30, view more
58411-245-30, 58411-246-30, 58411-247-30, 58411-248-30, 58411-249-30, 58411-250-30, 58411-251-30, 58411-252-30
Packager: SHISEIDO AMERICAS CORPORATION

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 23, 2019

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

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SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredients Purpose

OCTINOXATE 2.9% Sunscreen

TITANIUM DIOXIDE 3.3% 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

TALC•SYNTHETIC FLUORPHLOGOPITE•BARIUM SULFATE•ZINC OXIDE•TRIETHYLHEXANOIN•DIMETHICONE•SILICA•NYLON-12•STEAROXYMETHICONE/DIMETHICONE COPOLYMER•VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER•CALCIUM ALUMINUM BOROSILICATE•DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER•DIPHENYLSILOXY PHENYL TRIMETHICONE•HYDROGENATED POLYISOBUTENE•ROSA ROXBURGHII FRUIT EXTRACT•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•SODIUM ACETYLATED HYALURONATE•SORBITAN SESQUIISOSTEARATE•ALUMINUM HYDROXIDE•TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE•ALUMINUM DISTEARATE•METHICONE•TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE•SODIUM MAGNESIUM SILICATE•POLYSILICONE-2•MAGNESIUM MYRISTATE•BUTYLENE GLYCOL•WATER•GLYCERIN•TOCOPHEROL•DIMETHICONE/METHICONE COPOLYMER•HYDROGEN DIMETHICONE•BHT•POLYMETHYLSILSESQUIOXANE•ALUMINA•CHLORPHENESIN•FRAGRANCE•MICA•TITANIUM DIOXIDE•BISMUTH OXYCHLORIDE•IRON OXIDES•
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 - 11 g Tray Carton - I10

clé de peau
BEAUTÉ

radiant powder foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

11g NET WT. .38 OZ.
PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - O10

clé de peau
BEAUTÉ

radiant powder foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

11g NET WT. .38 OZ.
PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - O20

clé de peau
BEAUTÉ

radiant powder foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

11g NET WT. .38 OZ.
PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - O30

clé de peau
BEAUTÉ

radiant powder foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

11g NET WT. .38 OZ.
PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - O40

clé de peau
BEAUTÉ

radiant powder foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

11g NET WT. .38 OZ.
PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - O50

clé de peau
BEAUTÉ

radiant powder foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

11g NET WT. .38 OZ.
PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - O60

clé de peau
BEAUTÉ

radiant powder foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

11g NET WT. .38 OZ.
PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - B10

clé de peau
BEAUTÉ

radiant powder foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

11g NET WT. .38 OZ.
PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - B20

clé de peau
BEAUTÉ

radiant powder foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

11g NET WT. .38 OZ.
PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - B30

clé de peau
BEAUTÉ

radiant powder foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

11g NET WT. .38 OZ.
PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - BF20

clé de peau
BEAUTÉ

radiant powder foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

11g NET WT. .38 OZ.
PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - WB20

clé de peau
BEAUTÉ

radiant powder foundation

BROAD SPECTRUM SPF 23
SUNSCREEN

11g NET WT. .38 OZ.

Active ingredients	Purpose
OCTINOXATE 2.9%	Sunscreen
TITANIUM DIOXIDE 3.3%	Sunscreen

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE RADIANT FOUNDATION I10
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-241
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	319 mg in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	363 mg in 11 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-241-30	1 in 1 CARTON	03/01/2015
1		11 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/01/2015

CLE DE PEAU BEAUTE RADIANT FOUNDATION O10
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-242
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	319 mg in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	363 mg in 11 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-242-30	1 in 1 CARTON	03/01/2015
1		11 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/01/2015

CLE DE PEAU BEAUTE RADIANT FOUNDATION O20
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-243
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	319 mg in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	363 mg in 11 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-243-30	1 in 1 CARTON	03/01/2015
1		11 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/01/2015

CLE DE PEAU BEAUTE RADIANT FOUNDATION O30
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-244
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	319 mg in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	363 mg in 11 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-244-30	1 in 1 CARTON	03/01/2015
1		11 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/01/2015

CLE DE PEAU BEAUTE RADIANT FOUNDATION O40
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-245
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	319 mg in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	363 mg in 11 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-245-30	1 in 1 CARTON	03/01/2015
1		11 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/01/2015

CLE DE PEAU BEAUTE RADIANT FOUNDATION O50
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-246
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	319 mg in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	363 mg in 11 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-246-30	1 in 1 CARTON	03/01/2015
1		11 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/01/2015

CLE DE PEAU BEAUTE RADIANT FOUNDATION O60
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-247
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	319 mg in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	363 mg in 11 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-247-30	1 in 1 CARTON	03/01/2015
1		11 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/01/2015

CLE DE PEAU BEAUTE RADIANT FOUNDATION B10
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-248
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	319 mg in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	363 mg in 11 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-248-30	1 in 1 CARTON	03/01/2015
1		11 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/01/2015

CLE DE PEAU BEAUTE RADIANT FOUNDATION B20
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-249
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	319 mg in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	363 mg in 11 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-249-30	1 in 1 CARTON	03/01/2015
1		11 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/01/2015

CLE DE PEAU BEAUTE RADIANT FOUNDATION B30
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-250
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	319 mg in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	363 mg in 11 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-250-30	1 in 1 CARTON	03/01/2015
1		11 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/01/2015

CLE DE PEAU BEAUTE RADIANT FOUNDATION BF20
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-251
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	319 mg in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	363 mg in 11 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-251-30	1 in 1 CARTON	03/01/2015
1		11 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/01/2015

CLE DE PEAU BEAUTE RADIANT FOUNDATION WB20
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-252
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	319 mg in 11 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	363 mg in 11 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ZINC OXIDE (UNII: SOI2LOH54Z)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
METHICONE (20 CST) (UNII: 6777U11MKT)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ALUMINUM OXIDE (UNII: LMI26O6933)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-252-30	1 in 1 CARTON	03/01/2015
1		11 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	03/01/2015

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Name	Address	ID/FEI	Business Operations
Establishment
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(58411-241, 58411-242, 58411-243, 58411-244, 58411-245, 58411-246, 58411-247, 58411-248, 58411-249, 58411-250, 58411-251, 58411-252) , ANALYSIS(58411-241, 58411-242, 58411-243, 58411-244, 58411-245, 58411-246, 58411-247, 58411-248, 58411-249, 58411-250, 58411-251, 58411-252)

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Published Date (What is this?)	Version	Files
Dec 24, 2019	2 (current)	download
Mar 2, 2015	1	download

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	NDC
1	58411-241-30
2	58411-242-30
3	58411-243-30
4	58411-244-30
5	58411-245-30
6	58411-246-30
7	58411-247-30
8	58411-248-30
9	58411-249-30
10	58411-250-30
11	58411-251-30
12	58411-252-30

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Number of versions: 2

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