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

Contains inactivated NDC Code(s)
NDC Code(s): 58411-193-60, 58411-194-60, 58411-195-60, 58411-196-60, view more
58411-197-60, 58411-198-60, 58411-199-60, 58411-200-60, 58411-201-60, 58411-202-60, 58411-203-60, 58411-204-60
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 13, 2018

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 4.9% Sunscreen

TITANIUM DIOXIDE 2.5% 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

DIMETHICONE∙WATER∙BUTYLENE GLYCOL∙GLYCERIN∙PEG-10 DIMETHICONE∙CYCLOMETHICONE∙BIS-BUTYLDIMETHICONE POLYGLYCERYL-3∙POLYMETHYLSILSESQUIOXANE∙ERYTHRITOL∙XYLITOL∙BARIUM SULFATE∙DIPHENYLSILOXY PHENYL TRIMETHICONE∙DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER∙POLYQUATERNIUM-51∙SODIUM ACETYLATED HYALURONATE∙ROSA ROXBURGHII FRUIT EXTRACT∙HYDROLYZED CONCHIOLIN PROTEIN∙HYDROLYZED SILK∙SYNTHETIC FLUORPHLOGOPITE∙DIMETHICONE/PEG-10/15 CROSSPOLYMER∙DISTEARDIMONIUM HECTORITE∙SORBITAN SESQUIISOSTEARATE∙ALUMINUM HYDROXIDE∙ALUMINUM DISTEARATE∙DISODIUM EDTA∙ALUMINA∙TRIETHOXYCAPRYLYLSILANE∙POLYSILICONE-2∙TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE∙TOCOPHEROL∙DIPROPYLENE GLYCOL∙SILICA∙VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER∙BHT∙ALCOHOL∙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 - 30 mL Tube Carton - I10

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - O10

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - O20

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - O30

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - O40

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - O50

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - O60

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - B10

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - B20

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - B30

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - BF20

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.
PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - WB20

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.

Active ingredients	Purpose
OCTINOXATE 4.9%	Sunscreen
TITANIUM DIOXIDE 2.5%	Sunscreen

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION I10
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-193
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1617 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	825 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-193-60	1 in 1 CARTON	09/01/2014
1		30 mL in 1 TUBE; 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	09/01/2014

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O10
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-194
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1617 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	825 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-194-60	1 in 1 CARTON	09/01/2014
1		30 mL in 1 TUBE; 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	09/01/2014

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O20
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-195
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1617 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	825 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-195-60	1 in 1 CARTON	09/01/2014
1		30 mL in 1 TUBE; 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	09/01/2014

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O30
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-196
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1617 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	825 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-196-60	1 in 1 CARTON	09/01/2014
1		30 mL in 1 TUBE; 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	09/01/2014

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O40
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-197
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1617 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	825 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-197-60	1 in 1 CARTON	09/01/2014
1		30 mL in 1 TUBE; 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	09/01/2014

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O50
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-198
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1617 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	825 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-198-60	1 in 1 CARTON	09/01/2014
1		30 mL in 1 TUBE; 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	09/01/2014

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O60
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-199
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1617 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	825 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-199-60	1 in 1 CARTON	09/01/2014
1		30 mL in 1 TUBE; 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	09/01/2014

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B10
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-200
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1617 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	825 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-200-60	1 in 1 CARTON	09/01/2014
1		30 mL in 1 TUBE; 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	09/01/2014

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B20
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-201
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1617 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	825 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-201-60	1 in 1 CARTON	09/01/2014
1		30 mL in 1 TUBE; 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	09/01/2014

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B30
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-202
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1617 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	825 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-202-60	1 in 1 CARTON	09/01/2014
1		30 mL in 1 TUBE; 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	09/01/2014

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION BF20
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-203
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1617 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	825 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-203-60	1 in 1 CARTON	09/01/2014
1		30 mL in 1 TUBE; 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	09/01/2014

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION WB20
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-204
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1617 mg in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	825 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-204-60	1 in 1 CARTON	09/01/2014
1		30 mL in 1 TUBE; 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	09/01/2014

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Name	Address	ID/FEI	Business Operations
Establishment
SHISEIDO AMERICA INC.		782677132	manufacture(58411-193, 58411-194, 58411-195, 58411-196, 58411-197, 58411-198, 58411-199, 58411-200, 58411-201, 58411-202, 58411-203, 58411-204) , analysis(58411-193, 58411-194, 58411-195, 58411-196, 58411-197, 58411-198, 58411-199, 58411-200, 58411-201, 58411-202, 58411-203, 58411-204)

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Published Date (What is this?)	Version	Files
Dec 14, 2018	2 (current)	download
Sep 2, 2014	1	download

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	NDC
1	58411-193-60 (inactivated)
2	58411-194-60
3	58411-195-60
4	58411-196-60
5	58411-197-60
6	58411-198-60
7	58411-199-60
8	58411-200-60
9	58411-201-60
10	58411-202-60
11	58411-203-60
12	58411-204-60

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Number of versions: 2

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If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.