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

cle de peau beaute radiant cream to powder foundation by

Drug Labeling and Warnings

cle de peau beaute radiant cream to powder 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
(For shades I10, O10, O20, O30, B10, B20, B30, BF20, WB20)
OCTINOXATE 3.4%	Sunscreen
TITANIUM DIOXIDE 4.3%	Sunscreen
(For shades O40, O50, O60)
OCTINOXATE 3.4%	Sunscreen
TITANIUM DIOXIDE 5.2%	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

I10

DIMETHICONEWATERPOLYMETHYLSILSESQUIOXANEBARIUM SULFATEDIPROPYLENE GLYCOLGLYCERINPARAFFINPEG-10 DIMETHICONEXANTHAN GUMTREHALOSEDIMETHICONE/VINYL DIMETHICONE CROSSPOLYMERSODIUM ACETYLATED HYALURONATEPEG/PPG-14/7 DIMETHYL ETHERTRIMETHYLSILOXYSILICATEROSA ROXBURGHII FRUIT EXTRACTPOLYQUATERNIUM-51HYDROLYZED CONCHIOLIN PROTEINHYDROLYZED SILKSILICAORYZA SATIVA (RICE) BRAN WAXSORBITAN SESQUIISOSTEARATEHYDRATED SILICADISTEARYLDIMONIUM CHLORIDESILICA DIMETHYL SILYLATEPALMITIC ACIDDISTEARDIMONIUM HECTORITEMICROCRYSTALLINE WAXTRISODIUM EDTAALUMINASODIUM METAPHOSPHATEMAGNESIUM MYRISTATECELLULOSE GUMISOPROPYL ALCOHOLTOCOPHEROLVINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMERDIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMERSYNTHETIC FLUORPHLOGOPITEBHTBUTYLENE GLYCOLTRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONETHEANINEETHYLPARABENMETHYLPARABENPHENOXYETHANOLFRAGRANCETITANIUM DIOXIDEIRON OXIDESMICA

O10, O20, O30, B10, B20, B30, BF20, WB20

DIMETHICONEWATERPOLYMETHYLSILSESQUIOXANEBARIUM SULFATEDIPROPYLENE GLYCOLGLYCERINPARAFFINPEG-10 DIMETHICONESILICAXANTHAN GUMTREHALOSEDIMETHICONE/VINYL DIMETHICONE CROSSPOLYMERSODIUM ACETYLATED HYALURONATEPEG/PPG-14/7 DIMETHYL ETHERTRIMETHYLSILOXYSILICATEROSA ROXBURGHII FRUIT EXTRACTPOLYQUATERNIUM-51HYDROLYZED CONCHIOLIN PROTEINHYDROLYZED SILKORYZA SATIVA (RICE) BRAN WAXSORBITAN SESQUIISOSTEARATEHYDRATED SILICADISTEARYLDIMONIUM CHLORIDESILICA DIMETHYL SILYLATEPALMITIC ACIDDISTEARDIMONIUM HECTORITEMICROCRYSTALLINE WAXTRISODIUM EDTAALUMINASODIUM METAPHOSPHATEMAGNESIUM MYRISTATECELLULOSE GUMISOPROPYL ALCOHOLTOCOPHEROLVINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMERDIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMERSYNTHETIC FLUORPHLOGOPITEBHTBUTYLENE GLYCOLPOLYSILICONE-2TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONETHEANINEETHYLPARABENMETHYLPARABENPHENOXYETHANOLFRAGRANCETITANIUM DIOXIDEIRON OXIDESMICA

O40, O50, O60

DIMETHICONEWATERPOLYMETHYLSILSESQUIOXANEBARIUM SULFATEDIPROPYLENE GLYCOLGLYCERINPARAFFINPEG-10 DIMETHICONEXANTHAN GUMTREHALOSEDIMETHICONE/VINYL DIMETHICONE CROSSPOLYMERSODIUM ACETYLATED HYALURONATEPEG/PPG-14/7 DIMETHYL ETHERTRIMETHYLSILOXYSILICATEROSA ROXBURGHII FRUIT EXTRACTPOLYQUATERNIUM-51HYDROLYZED CONCHIOLIN PROTEINHYDROLYZED SILKSILICAORYZA SATIVA (RICE) BRAN WAXHYDRATED SILICASORBITAN SESQUIISOSTEARATEDISTEARYLDIMONIUM CHLORIDESILICA DIMETHYL SILYLATEPALMITIC ACIDDISTEARDIMONIUM HECTORITEMICROCRYSTALLINE WAXTRISODIUM EDTAALUMINASODIUM METAPHOSPHATEMAGNESIUM MYRISTATECELLULOSE GUMISOPROPYL ALCOHOLTOCOPHEROLVINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMERDIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMERSYNTHETIC FLUORPHLOGOPITEPOLYSILICONE-2BHTBUTYLENE GLYCOLTRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONETHEANINEETHYLPARABENMETHYLPARABENPHENOXYETHANOLFRAGRANCETITANIUM 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 - 12 g Container Carton - I10

clé de peau
BEAUTÉ

radiant cream to powder foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - O10

clé de peau
BEAUTÉ

radiant cream to powder foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - O20

clé de peau
BEAUTÉ

radiant cream to powder foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - O30

clé de peau
BEAUTÉ

radiant cream to powder foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - O40

clé de peau
BEAUTÉ

radiant cream to powder foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - O50

clé de peau
BEAUTÉ

radiant cream to powder foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - O60

clé de peau
BEAUTÉ

radiant cream to powder foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - B10

clé de peau
BEAUTÉ

radiant cream to powder foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - B20

clé de peau
BEAUTÉ

radiant cream to powder foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - B30

clé de peau
BEAUTÉ

radiant cream to powder foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - BF20

clé de peau
BEAUTÉ

radiant cream to powder foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Container Carton - WB20

clé de peau
BEAUTÉ

radiant cream to powder foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

12g NET WT. .42 OZ.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-427
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	408 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	516 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
PARAFFIN (UNII: I9O0E3H2ZE)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
XANTHAN GUM (UNII: TTV12P4NEE)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
RICE BRAN (UNII: R60QEP13IC)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PALMITIC ACID (UNII: 2V16EO95H1)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
THEANINE (UNII: 8021PR16QO)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
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: 58411-427-30	1 in 1 CARTON	06/01/2018
1		12 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2018

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-428
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	408 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	516 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
PARAFFIN (UNII: I9O0E3H2ZE)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XANTHAN GUM (UNII: TTV12P4NEE)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
RICE BRAN (UNII: R60QEP13IC)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PALMITIC ACID (UNII: 2V16EO95H1)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
THEANINE (UNII: 8021PR16QO)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
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: 58411-428-30	1 in 1 CARTON	06/01/2018
1		12 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2018

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-429
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	408 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	516 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
PARAFFIN (UNII: I9O0E3H2ZE)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XANTHAN GUM (UNII: TTV12P4NEE)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
RICE BRAN (UNII: R60QEP13IC)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PALMITIC ACID (UNII: 2V16EO95H1)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
THEANINE (UNII: 8021PR16QO)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
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: 58411-429-30	1 in 1 CARTON	06/01/2018
1		12 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2018

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-430
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	408 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	516 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
PARAFFIN (UNII: I9O0E3H2ZE)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XANTHAN GUM (UNII: TTV12P4NEE)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
RICE BRAN (UNII: R60QEP13IC)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PALMITIC ACID (UNII: 2V16EO95H1)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
THEANINE (UNII: 8021PR16QO)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
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: 58411-430-30	1 in 1 CARTON	06/01/2018
1		12 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2018

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-431
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	408 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	624 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
PARAFFIN (UNII: I9O0E3H2ZE)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
XANTHAN GUM (UNII: TTV12P4NEE)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
RICE BRAN (UNII: R60QEP13IC)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PALMITIC ACID (UNII: 2V16EO95H1)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
THEANINE (UNII: 8021PR16QO)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
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: 58411-431-30	1 in 1 CARTON	06/01/2018
1		12 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2018

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-432
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	408 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	624 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
PARAFFIN (UNII: I9O0E3H2ZE)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
XANTHAN GUM (UNII: TTV12P4NEE)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
RICE BRAN (UNII: R60QEP13IC)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PALMITIC ACID (UNII: 2V16EO95H1)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
THEANINE (UNII: 8021PR16QO)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
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: 58411-432-30	1 in 1 CARTON	06/01/2018
1		12 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2018

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-433
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	408 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	624 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
PARAFFIN (UNII: I9O0E3H2ZE)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
XANTHAN GUM (UNII: TTV12P4NEE)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
RICE BRAN (UNII: R60QEP13IC)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PALMITIC ACID (UNII: 2V16EO95H1)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
THEANINE (UNII: 8021PR16QO)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
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: 58411-433-30	1 in 1 CARTON	06/01/2018
1		12 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2018

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-434
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	408 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	516 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
PARAFFIN (UNII: I9O0E3H2ZE)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XANTHAN GUM (UNII: TTV12P4NEE)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
RICE BRAN (UNII: R60QEP13IC)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PALMITIC ACID (UNII: 2V16EO95H1)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
THEANINE (UNII: 8021PR16QO)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
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: 58411-434-30	1 in 1 CARTON	06/01/2018
1		12 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2018

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-435
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	408 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	516 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
PARAFFIN (UNII: I9O0E3H2ZE)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XANTHAN GUM (UNII: TTV12P4NEE)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
RICE BRAN (UNII: R60QEP13IC)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PALMITIC ACID (UNII: 2V16EO95H1)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
THEANINE (UNII: 8021PR16QO)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
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: 58411-435-30	1 in 1 CARTON	06/01/2018
1		12 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2018

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-436
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	408 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	516 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
PARAFFIN (UNII: I9O0E3H2ZE)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XANTHAN GUM (UNII: TTV12P4NEE)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
RICE BRAN (UNII: R60QEP13IC)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PALMITIC ACID (UNII: 2V16EO95H1)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
THEANINE (UNII: 8021PR16QO)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
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: 58411-436-30	1 in 1 CARTON	06/01/2018
1		12 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2018

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-437
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	408 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	516 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
PARAFFIN (UNII: I9O0E3H2ZE)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XANTHAN GUM (UNII: TTV12P4NEE)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
RICE BRAN (UNII: R60QEP13IC)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PALMITIC ACID (UNII: 2V16EO95H1)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
THEANINE (UNII: 8021PR16QO)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
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: 58411-437-30	1 in 1 CARTON	06/01/2018
1		12 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2018

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-438
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	408 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	516 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
PARAFFIN (UNII: I9O0E3H2ZE)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XANTHAN GUM (UNII: TTV12P4NEE)
TREHALOSE (UNII: B8WCK70T7I)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
RICE BRAN (UNII: R60QEP13IC)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PALMITIC ACID (UNII: 2V16EO95H1)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
THEANINE (UNII: 8021PR16QO)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
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: 58411-438-30	1 in 1 CARTON	06/01/2018
1		12 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2018

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(58411-427, 58411-428, 58411-429, 58411-430, 58411-431, 58411-432, 58411-433, 58411-434, 58411-435, 58411-436, 58411-437, 58411-438) , ANALYSIS(58411-427, 58411-428, 58411-429, 58411-430, 58411-431, 58411-432, 58411-433, 58411-434, 58411-435, 58411-436, 58411-437, 58411-438)