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

CLE DE PEAU BEAUTE RADIANT FOUNDATION by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE RADIANT FOUNDATION 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

Active ingredients	Purpose
OCTINOXATE 4.4%	Sunscreen
TITANIUM DIOXIDE 1.2%	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

WATERDIMETHICONEDIPHENYLSILOXY PHENYL TRIMETHICONEDIPROPYLENE GLYCOLGLYCERINBUTYLENE GLYCOLPEG-10 DIMETHICONEPEG-20LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONESYNTHETIC FLUORPHLOGOPITEPEG-6PEG-32DISTEARDIMONIUM HECTORITEDIMETHICONE/VINYL DIMETHICONE CROSSPOLYMERTREHALOSEPEG/PPG-14/7 DIMETHYL ETHERSODIUM ACETYLATED HYALURONATEROSA ROXBURGHII FRUIT EXTRACTORIGANUM MAJORANA LEAF EXTRACTPOLYQUATERNIUM-51HYDROLYZED CONCHIOLIN PROTEINHYDROLYZED SILKDIPENTAERYTHRITYL HEXAHYDROXYSTEARATEALUMINADIMETHICONE/PHENYL VINYL DIMETHICONE CROSSPOLYMERSORBITAN SESQUIISOSTEARATETRIETHOXYCAPRYLYLSILANETRISODIUM EDTAALUMINUM DISTEARATEALUMINUM HYDROXIDEPOLYSILICONE-2POLYMETHYLSILSESQUIOXANETRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONEHYDROGEN DIMETHICONESILICAVINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMERTIN OXIDEBHTTOCOPHEROLTHEANINESODIUM DEHYDROACETATEMETHYLPARABENETHYLPARABENPHENOXYETHANOLFRAGRANCETITANIUM DIOXIDEIRON OXIDESMICA

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 - 21 mL Tube Carton - I10

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O10

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O20

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O30

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B10

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B20

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - B30

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - BF20

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O40

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O50

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - O60

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

PRINCIPAL DISPLAY PANEL - 21 mL Tube Carton - WB20

clé de peau
BEAUTÉ

radiant cream foundation

BROAD SPECTRUM SPF 24
SUNSCREEN

21mL NET WT. .87 OZ.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-272
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
TREHALOSE (UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STANNIC OXIDE (UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
THEANINE (UNII: 8021PR16QO)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
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: 58411-272-60	1 in 1 CARTON	08/01/2016
1		21 mL 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	08/01/2016

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-273
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
TREHALOSE (UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STANNIC OXIDE (UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
THEANINE (UNII: 8021PR16QO)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
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: 58411-273-60	1 in 1 CARTON	08/01/2016
1		21 mL 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	08/01/2016

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-274
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
TREHALOSE (UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STANNIC OXIDE (UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
THEANINE (UNII: 8021PR16QO)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
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: 58411-274-60	1 in 1 CARTON	08/01/2016
1		21 mL 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	08/01/2016

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-275
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
TREHALOSE (UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STANNIC OXIDE (UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
THEANINE (UNII: 8021PR16QO)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
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: 58411-275-60	1 in 1 CARTON	08/01/2016
1		21 mL 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	08/01/2016

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-276
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
TREHALOSE (UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STANNIC OXIDE (UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
THEANINE (UNII: 8021PR16QO)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
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: 58411-276-60	1 in 1 CARTON	08/01/2016
1		21 mL 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	08/01/2016

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-277
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
TREHALOSE (UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STANNIC OXIDE (UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
THEANINE (UNII: 8021PR16QO)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
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: 58411-277-60	1 in 1 CARTON	08/01/2016
1		21 mL 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	08/01/2016

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-278
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
TREHALOSE (UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STANNIC OXIDE (UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
THEANINE (UNII: 8021PR16QO)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
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: 58411-278-60	1 in 1 CARTON	08/01/2016
1		21 mL 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	08/01/2016

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-279
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
TREHALOSE (UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STANNIC OXIDE (UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
THEANINE (UNII: 8021PR16QO)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
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: 58411-279-60	1 in 1 CARTON	08/01/2016
1		21 mL 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	08/01/2016

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-280
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
TREHALOSE (UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STANNIC OXIDE (UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
THEANINE (UNII: 8021PR16QO)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-280-60	1 in 1 CARTON	08/01/2016
1		21 mL 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	08/01/2016

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-281
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
TREHALOSE (UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STANNIC OXIDE (UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
THEANINE (UNII: 8021PR16QO)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
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: 58411-281-60	1 in 1 CARTON	08/01/2016
1		21 mL 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	08/01/2016

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-282
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
TREHALOSE (UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STANNIC OXIDE (UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
THEANINE (UNII: 8021PR16QO)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
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: 58411-282-60	1 in 1 CARTON	08/01/2016
1		21 mL 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	08/01/2016

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-283
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1072 mg  in 21 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	292 mg  in 21 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
TREHALOSE (UNII: B8WCK70T7I)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STANNIC OXIDE (UNII: KM7N50LOS6)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
THEANINE (UNII: 8021PR16QO)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
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: 58411-283-60	1 in 1 CARTON	08/01/2016
1		21 mL 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	08/01/2016

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-272, 58411-273, 58411-274, 58411-275, 58411-276, 58411-277, 58411-278, 58411-279, 58411-280, 58411-281, 58411-282, 58411-283) , analysis(58411-272, 58411-273, 58411-274, 58411-275, 58411-276, 58411-277, 58411-278, 58411-279, 58411-280, 58411-281, 58411-282, 58411-283)