CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O70- octinoxate and titanium dioxide emulsion
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O80- octinoxate and titanium dioxide emulsion
SHISEIDO AMERICAS CORPORATION

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.

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CLÉ DE PEAU BEAUTÉ RADIANT FLUID FOUNDATION

Drug Facts

Active ingredients	Purpose
Octinoxate 4.9%	Sunscreen
Titanium Dioxide 2.5%	Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor

Inactive Ingredients

DIMETHICONE▪WATER▪BUTYLENE GLYCOL▪GLYCERIN▪PEG-10 DIMETHICONE▪CYCLOHEXASILOXANE▪BIS-BUTYLDIMETHICONE POLYGLYCERYL-3▪POLYMETHYLSILSESQUIOXANE▪ERYTHRITOL▪XYLITOL▪BARIUM SULFATE▪DIPHENYLSILOXY PHENYL TRIMETHICONE▪DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER▪POLYQUATERNIUM-51▪SODIUM ACETYLATED HYALURONATE▪ROSA ROXBURGHII FRUIT EXTRACT▪HYDROLYZED CONCHIOLIN PROTEIN▪HYDROLYZED SILK▪SYNTHETIC FLUORPHLOGOPITE▪DIMETHICONE/PEG-10/15 CROSSPOLYMER▪DISTEARDIMONIUM HECTORITE▪SORBITAN SESQUIISOSTEARATE▪ALUMINUM HYDROXIDE▪STEARIC ACID▪DISODIUM EDTA▪POLYSILICONE-2▪ALUMINA▪TRIETHOXYCAPRYLYLSILANE▪TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE▪TOCOPHEROL▪DIPROPYLENE GLYCOL▪SILICA▪VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER▪BHT▪ALCOHOL▪PHENOXYETHANOL▪FRAGRANCE▪IRON OXIDES▪TITANIUM DIOXIDE▪MICA▪

Other information

Protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - 58411-477

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - 58411-477

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - 58411-478

clé de peau
BEAUTÉ

radiant fluid foundation

BROAD SPECTRUM
SPF 24
SUNSCREEN

30mL 1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - 58411-478

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O70
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-477
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.6611 g in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.8475 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58411-477-20	1 in 1 CARTON	05/01/2019
1		30 mL in 1 CARTRIDGE; 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	05/01/2019

CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O80
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-478
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.6611 g in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.8475 mg in 30 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
BARIUM SULFATE (UNII: 25BB7EKE2E)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58411-478-20	1 in 1 CARTON	05/01/2019
1		30 mL in 1 CARTRIDGE; 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	05/01/2019

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Name	Address	ID/FEI	Business Operations
Establishment
SHISEIDO AMERICAS INC.		782677132	MANUFACTURE(58411-477, 58411-478) , ANALYSIS(58411-477, 58411-478)

Revised: 11/2019

Document Id: 42b45aca-3841-4681-9dd5-168e5d5ac46d

Set id: d4b6a6c1-0a57-404d-a4fc-0d14b9db1df6

Version: 1

Effective Time: 20191111

SHISEIDO AMERICAS CORPORATION