DailyMed - 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

NDC Code(s): 58411-427-30, 58411-428-30, 58411-429-30, 58411-430-30, view more
58411-431-30, 58411-432-30, 58411-433-30, 58411-434-30, 58411-435-30, 58411-436-30, 58411-437-30, 58411-438-30
Packager: SHISEIDO AMERICAS CORPORATION

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph 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 May 9, 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
(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

DIMETHICONE•WATER•POLYMETHYLSILSESQUIOXANE•BARIUM SULFATE•DIPROPYLENE GLYCOL•GLYCERIN•PARAFFIN•PEG-10 DIMETHICONE•XANTHAN GUM•TREHALOSE•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•SODIUM ACETYLATED HYALURONATE•PEG/PPG-14/7 DIMETHYL ETHER•TRIMETHYLSILOXYSILICATE•ROSA ROXBURGHII FRUIT EXTRACT•POLYQUATERNIUM-51•HYDROLYZED CONCHIOLIN PROTEIN•HYDROLYZED SILK•SILICA•ORYZA SATIVA (RICE) BRAN WAX•SORBITAN SESQUIISOSTEARATE•HYDRATED SILICA•DISTEARYLDIMONIUM CHLORIDE•SILICA DIMETHYL SILYLATE•PALMITIC ACID•DISTEARDIMONIUM HECTORITE•MICROCRYSTALLINE WAX•TRISODIUM EDTA•ALUMINA•SODIUM METAPHOSPHATE•MAGNESIUM MYRISTATE•CELLULOSE GUM•ISOPROPYL ALCOHOL•TOCOPHEROL•VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER•DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER•SYNTHETIC FLUORPHLOGOPITE•BHT•BUTYLENE GLYCOL•TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE•THEANINE•ETHYLPARABEN•METHYLPARABEN•PHENOXYETHANOL•FRAGRANCE•TITANIUM DIOXIDE•IRON OXIDES•MICA•

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

DIMETHICONE•WATER•POLYMETHYLSILSESQUIOXANE•BARIUM SULFATE•DIPROPYLENE GLYCOL•GLYCERIN•PARAFFIN•PEG-10 DIMETHICONE•SILICA•XANTHAN GUM•TREHALOSE•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•SODIUM ACETYLATED HYALURONATE•PEG/PPG-14/7 DIMETHYL ETHER•TRIMETHYLSILOXYSILICATE•ROSA ROXBURGHII FRUIT EXTRACT•POLYQUATERNIUM-51•HYDROLYZED CONCHIOLIN PROTEIN•HYDROLYZED SILK•ORYZA SATIVA (RICE) BRAN WAX•SORBITAN SESQUIISOSTEARATE•HYDRATED SILICA•DISTEARYLDIMONIUM CHLORIDE•SILICA DIMETHYL SILYLATE•PALMITIC ACID•DISTEARDIMONIUM HECTORITE•MICROCRYSTALLINE WAX•TRISODIUM EDTA•ALUMINA•SODIUM METAPHOSPHATE•MAGNESIUM MYRISTATE•CELLULOSE GUM•ISOPROPYL ALCOHOL•TOCOPHEROL•VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER•DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER•SYNTHETIC FLUORPHLOGOPITE•BHT•BUTYLENE GLYCOL•POLYSILICONE-2•TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE•THEANINE•ETHYLPARABEN•METHYLPARABEN•PHENOXYETHANOL•FRAGRANCE•TITANIUM DIOXIDE•IRON OXIDES•MICA•

O40, O50, O60

DIMETHICONE•WATER•POLYMETHYLSILSESQUIOXANE•BARIUM SULFATE•DIPROPYLENE GLYCOL•GLYCERIN•PARAFFIN•PEG-10 DIMETHICONE•XANTHAN GUM•TREHALOSE•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•SODIUM ACETYLATED HYALURONATE•PEG/PPG-14/7 DIMETHYL ETHER•TRIMETHYLSILOXYSILICATE•ROSA ROXBURGHII FRUIT EXTRACT•POLYQUATERNIUM-51•HYDROLYZED CONCHIOLIN PROTEIN•HYDROLYZED SILK•SILICA•ORYZA SATIVA (RICE) BRAN WAX•HYDRATED SILICA•SORBITAN SESQUIISOSTEARATE•DISTEARYLDIMONIUM CHLORIDE•SILICA DIMETHYL SILYLATE•PALMITIC ACID•DISTEARDIMONIUM HECTORITE•MICROCRYSTALLINE WAX•TRISODIUM EDTA•ALUMINA•SODIUM METAPHOSPHATE•MAGNESIUM MYRISTATE•CELLULOSE GUM•ISOPROPYL ALCOHOL•TOCOPHEROL•VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER•DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER•SYNTHETIC FLUORPHLOGOPITE•POLYSILICONE-2•BHT•BUTYLENE GLYCOL•TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE•THEANINE•ETHYLPARABEN•METHYLPARABEN•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 - 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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	06/01/2018

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Name	Address	ID/FEI	Business Operations
Establishment
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)

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Drug Label Information

I10

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

O40, O50, O60

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	NDC
1	58411-427-30
2	58411-428-30
3	58411-429-30
4	58411-430-30
5	58411-431-30
6	58411-432-30
7	58411-433-30
8	58411-434-30
9	58411-435-30
10	58411-436-30
11	58411-437-30
12	58411-438-30

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More Info For This Drug

Drug Label Information

I10

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

O40, O50, O60

Find additional resources

Safety

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More Info on this Drug

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