CLE DE PEAU BEAUTE PW FOUNDATION s BF20

Dosage form: powder
Ingredients: Octinoxate 209mg in 11g, Titanium dioxide 363mg in 11g
Labeler: SHISEIDO CO., LTD.
NDC Code: 52685-364

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.

CLE DE PEAU BEAUTE PW FOUNDATION s

Drug Facts

Active ingredientsPurpose
OCTINOXATE1.9%Sunscreen
TITANIUM DIOXIDE3.3%Sunscreen

Use
  • 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

TALC, SYNTHETIC FLUORPHLOGOPITE, BARIUM SULFATE∙ DIMETHICONE, TRIETHYLHEXANOIN, BIS-BEHENYL/PHYTOSTERYL DIMER DILINOLEATE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, SILICA, NYLON-12, SILICA DIMETHYL SILYLATE, TOCOPHERYL ACETATE, PRUNUS SPECIOSA LEAF EXTRACT∙ SODIUM ACETYLATED HYALURONATE, ROSA ROXBURGHII FRUIT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, SORBITAN SESQUIISOSTEARATE, TRIETHOXYSILYLETHYL, POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE, METHICONE, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE, SODIUM MAGNESIUM SILICATE, POLYSILICONE-2, GLYCERIN, TOCOPHEROL, WATER, BUTYLENE GLYCOL, ALCOHOL, BHT, CHLORPHENESIN, FRAGRANCE, TITANIUM DIOXIDE, MICA, ZINC OXIDE, IRON OXIDES

Other information
  • protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

Manufactured by SHISEIDO CO., LTD. 7-5-5 GINZA TOKYO

PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - BF20

clé de peau
BEAUTÉ

powder foundation

BROAD SPECTRUM
SPF 22
SUNSCREEN

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - I10

clé de peau
BEAUTÉ

powder foundation

BROAD SPECTRUM
SPF 22
SUNSCREEN

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - O10

clé de peau
BEAUTÉ

powder foundation

BROAD SPECTRUM
SPF 22
SUNSCREEN

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - O20

clé de peau
BEAUTÉ

powder foundation

BROAD SPECTRUM
SPF 22
SUNSCREEN

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - O30

clé de peau
BEAUTÉ

powder foundation

BROAD SPECTRUM
SPF 22
SUNSCREEN

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - B10

clé de peau
BEAUTÉ

powder foundation

BROAD SPECTRUM
SPF 22
SUNSCREEN

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - B20

clé de peau
BEAUTÉ

powder foundation

BROAD SPECTRUM
SPF 22
SUNSCREEN

11g NET WT. .38 OZ.

PRINCIPAL DISPLAY PANEL - 11 g Tray Carton - B30

clé de peau
BEAUTÉ

powder foundation

BROAD SPECTRUM
SPF 22
SUNSCREEN

11g NET WT. .38 OZ.

CLE DE PEAU BEAUTE PW FOUNDATION S   BF20
octinoxate and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-364
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate209 mg  in 11 g
Titanium dioxide (Titanium dioxide) Titanium dioxide363 mg  in 11 g
Inactive Ingredients
Ingredient NameStrength
TALC 
MICA 
BARIUM SULFATE 
DIMETHICONE 
ZINC OXIDE 
TRIETHYLHEXANOIN 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
NYLON-12 
SILICON DIOXIDE 
SILICA DIMETHYL SILYLATE 
ALUMINUM HYDROXIDE 
METHICONE (20 CST) 
ALUMINUM DISTEARATE 
CHLORPHENESIN 
GLYCERIN 
ALPHA-TOCOPHEROL 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
WATER 
BUTYLENE GLYCOL 
ALCOHOL 
BUTYLATED HYDROXYTOLUENE 
PRUNUS SPECIOSA LEAF 
ROSA ROXBURGHII FRUIT 
GREEN TEA LEAF 
Packaging
#Item CodePackage Description
1NDC:52685-364-301 TRAY (TRAY) in 1 CARTON
111 g in 1 TRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/2009
CLE DE PEAU BEAUTE PW FOUNDATION S   I10
octinoxate and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-365
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate209 mg  in 11 g
Titanium dioxide (Titanium dioxide) Titanium dioxide363 mg  in 11 g
Inactive Ingredients
Ingredient NameStrength
TALC 
MICA 
BARIUM SULFATE 
DIMETHICONE 
ZINC OXIDE 
TRIETHYLHEXANOIN 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
NYLON-12 
SILICON DIOXIDE 
SILICA DIMETHYL SILYLATE 
ALUMINUM HYDROXIDE 
METHICONE (20 CST) 
ALUMINUM DISTEARATE 
CHLORPHENESIN 
GLYCERIN 
ALPHA-TOCOPHEROL 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
WATER 
BUTYLENE GLYCOL 
ALCOHOL 
BUTYLATED HYDROXYTOLUENE 
PRUNUS SPECIOSA LEAF 
ROSA ROXBURGHII FRUIT 
GREEN TEA LEAF 
Packaging
#Item CodePackage Description
1NDC:52685-365-301 TRAY (TRAY) in 1 CARTON
111 g in 1 TRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/2009
CLE DE PEAU BEAUTE PW FOUNDATION S   O10
octinoxate and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-366
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate209 mg  in 11 g
Titanium dioxide (Titanium dioxide) Titanium dioxide363 mg  in 11 g
Inactive Ingredients
Ingredient NameStrength
TALC 
MICA 
BARIUM SULFATE 
DIMETHICONE 
ZINC OXIDE 
TRIETHYLHEXANOIN 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
NYLON-12 
SILICON DIOXIDE 
SILICA DIMETHYL SILYLATE 
ALUMINUM HYDROXIDE 
METHICONE (20 CST) 
ALUMINUM DISTEARATE 
CHLORPHENESIN 
GLYCERIN 
ALPHA-TOCOPHEROL 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
WATER 
BUTYLENE GLYCOL 
ALCOHOL 
BUTYLATED HYDROXYTOLUENE 
PRUNUS SPECIOSA LEAF 
ROSA ROXBURGHII FRUIT 
GREEN TEA LEAF 
Packaging
#Item CodePackage Description
1NDC:52685-366-301 TRAY (TRAY) in 1 CARTON
111 g in 1 TRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/2009
CLE DE PEAU BEAUTE PW FOUNDATION S   O20
octinoxate and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-367
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate209 mg  in 11 g
Titanium dioxide (Titanium dioxide) Titanium dioxide363 mg  in 11 g
Inactive Ingredients
Ingredient NameStrength
TALC 
MICA 
BARIUM SULFATE 
DIMETHICONE 
ZINC OXIDE 
TRIETHYLHEXANOIN 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
NYLON-12 
SILICON DIOXIDE 
SILICA DIMETHYL SILYLATE 
ALUMINUM HYDROXIDE 
METHICONE (20 CST) 
ALUMINUM DISTEARATE 
CHLORPHENESIN 
GLYCERIN 
ALPHA-TOCOPHEROL 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
WATER 
BUTYLENE GLYCOL 
ALCOHOL 
BUTYLATED HYDROXYTOLUENE 
PRUNUS SPECIOSA LEAF 
ROSA ROXBURGHII FRUIT 
GREEN TEA LEAF 
Packaging
#Item CodePackage Description
1NDC:52685-367-301 TRAY (TRAY) in 1 CARTON
111 g in 1 TRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/2009
CLE DE PEAU BEAUTE PW FOUNDATION S   O30
octinoxate and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-368
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate209 mg  in 11 g
Titanium dioxide (Titanium dioxide) Titanium dioxide363 mg  in 11 g
Inactive Ingredients
Ingredient NameStrength
TALC 
MICA 
BARIUM SULFATE 
DIMETHICONE 
ZINC OXIDE 
TRIETHYLHEXANOIN 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
NYLON-12 
SILICON DIOXIDE 
SILICA DIMETHYL SILYLATE 
ALUMINUM HYDROXIDE 
METHICONE (20 CST) 
ALUMINUM DISTEARATE 
CHLORPHENESIN 
GLYCERIN 
ALPHA-TOCOPHEROL 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
WATER 
BUTYLENE GLYCOL 
ALCOHOL 
BUTYLATED HYDROXYTOLUENE 
PRUNUS SPECIOSA LEAF 
ROSA ROXBURGHII FRUIT 
GREEN TEA LEAF 
Packaging
#Item CodePackage Description
1NDC:52685-368-301 TRAY (TRAY) in 1 CARTON
111 g in 1 TRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/2009
CLE DE PEAU BEAUTE PW FOUNDATION S   B10
octinoxate and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-369
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate209 mg  in 11 g
Titanium dioxide (Titanium dioxide) Titanium dioxide363 mg  in 11 g
Inactive Ingredients
Ingredient NameStrength
TALC 
MICA 
BARIUM SULFATE 
DIMETHICONE 
ZINC OXIDE 
TRIETHYLHEXANOIN 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
NYLON-12 
SILICON DIOXIDE 
SILICA DIMETHYL SILYLATE 
ALUMINUM HYDROXIDE 
METHICONE (20 CST) 
ALUMINUM DISTEARATE 
CHLORPHENESIN 
GLYCERIN 
ALPHA-TOCOPHEROL 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
WATER 
BUTYLENE GLYCOL 
ALCOHOL 
BUTYLATED HYDROXYTOLUENE 
PRUNUS SPECIOSA LEAF 
ROSA ROXBURGHII FRUIT 
GREEN TEA LEAF 
Packaging
#Item CodePackage Description
1NDC:52685-369-301 TRAY (TRAY) in 1 CARTON
111 g in 1 TRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/2009
CLE DE PEAU BEAUTE PW FOUNDATION S   B20
octinoxate and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-370
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate209 mg  in 11 g
Titanium dioxide (Titanium dioxide) Titanium dioxide363 mg  in 11 g
Inactive Ingredients
Ingredient NameStrength
TALC 
MICA 
BARIUM SULFATE 
DIMETHICONE 
ZINC OXIDE 
TRIETHYLHEXANOIN 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
NYLON-12 
SILICON DIOXIDE 
SILICA DIMETHYL SILYLATE 
ALUMINUM HYDROXIDE 
METHICONE (20 CST) 
ALUMINUM DISTEARATE 
CHLORPHENESIN 
GLYCERIN 
ALPHA-TOCOPHEROL 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
WATER 
BUTYLENE GLYCOL 
ALCOHOL 
BUTYLATED HYDROXYTOLUENE 
PRUNUS SPECIOSA LEAF 
ROSA ROXBURGHII FRUIT 
GREEN TEA LEAF 
Packaging
#Item CodePackage Description
1NDC:52685-370-301 TRAY (TRAY) in 1 CARTON
111 g in 1 TRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/2009
CLE DE PEAU BEAUTE PW FOUNDATION S   B30
octinoxate and titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-371
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate209 mg  in 11 g
Titanium dioxide (Titanium dioxide) Titanium dioxide363 mg  in 11 g
Inactive Ingredients
Ingredient NameStrength
TALC 
MICA 
BARIUM SULFATE 
DIMETHICONE 
ZINC OXIDE 
TRIETHYLHEXANOIN 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
NYLON-12 
SILICON DIOXIDE 
SILICA DIMETHYL SILYLATE 
ALUMINUM HYDROXIDE 
METHICONE (20 CST) 
ALUMINUM DISTEARATE 
CHLORPHENESIN 
GLYCERIN 
ALPHA-TOCOPHEROL 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
WATER 
BUTYLENE GLYCOL 
ALCOHOL 
BUTYLATED HYDROXYTOLUENE 
PRUNUS SPECIOSA LEAF 
ROSA ROXBURGHII FRUIT 
GREEN TEA LEAF 
Packaging
#Item CodePackage Description
1NDC:52685-371-301 TRAY (TRAY) in 1 CARTON
111 g in 1 TRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/2009
Labeler - SHISEIDO CO., LTD. (690536453)
Establishment
NameAddressID/FEIOperations
SHISEIDO CO., LTD.695088112MANUFACTURE(52685-364, 52685-365, 52685-366, 52685-367, 52685-368, 52685-369, 52685-370, 52685-371), ANALYSIS(52685-364, 52685-365, 52685-366, 52685-367, 52685-368, 52685-369, 52685-370, 52685-371)

Revised: 04/2012
 
SHISEIDO CO., LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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