Medication Guide App

CLE DE PEAU BEAUTE FOUNDATION I BF20

Dosage form: cream
Ingredients: Titanium dioxide 0.65625g in 31.25g
Labeler: SHISEIDO CO., LTD.
NDC Code: 52685-338

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 CR FOUNDATION L

Drug Facts

Active ingredient

TITANIUM DIOXIDE 2.1%

Purpose

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

WATER • CYCLOMETHICONE • TALC • BUTYLENE GLYCOL • NYLON-12 • DIMETHICONE • GLYCERIN • PEG-10 DIMETHICONE • DEXTRIN PALMITATE • BARIUM SULFATE • POLYMETHYL METHACRYLATE • TOCOPHERYL ACETATE • GINKGO BILOBA LEAF EXTRACT • SODIUM ACETYLATED HYALURONATE • ROSA ROXBURGHII FRUIT EXTRACT • LILIUM CANDIDUM BULB EXTRACT • ALUMINUM HYDROXIDE • PALMITIC ACID • STEARIC ACID • TRISODIUM EDTA • DISTEARYLDIMONIUM CHLORIDE • VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER • POLYSILICONE-2 • ISOPROPYL ALCOHOL • SYNTHETIC FLUORPHLOGOPITE • TOCOPHEROL • TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE • 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

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

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - BF20

clé de peau
BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - I10

clé de peau
BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - O10

clé de peau
BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - O20

clé de peau
BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - O30

clé de peau
BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - B10

clé de peau
BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - B20

clé de peau
BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 25 mL Tube Carton - B30

clé de peau
BEAUTÉ

cream foundation

BROAD SPECTRUM SPF 29
SUNSCREEN

25mL NET WT. 1.1 OZ.

CLE DE PEAU BEAUTE FOUNDATION I   BF20
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-338
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (Titanium dioxide) Titanium dioxide0.65625 g  in 31.25 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
TALC 
BUTYLENE GLYCOL 
NYLON-12 
DIMETHICONE 
GLYCERIN 
PEG-10 DIMETHICONE (600 CST) 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
TITANIUM DIOXIDE 
BARIUM SULFATE 
ALUMINUM HYDROXIDE 
PHENOXYETHANOL 
PALMITIC ACID 
STEARIC ACID 
EDETATE TRISODIUM 
DISTEARYLDIMONIUM CHLORIDE 
MICA 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
ISOPROPYL ALCOHOL 
GINKGO 
ROSA ROXBURGHII FRUIT 
.ALPHA.-TOCOPHEROL 
LILIUM CANDIDUM BULB 
Packaging
#Item CodePackage Description
1NDC:52685-338-601 TUBE (TUBE) in 1 CARTON
131.25 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2011
CLE DE PEAU BEAUTE FOUNDATION I   I10
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-339
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (Titanium dioxide) Titanium dioxide0.65625 g  in 31.25 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
TALC 
BUTYLENE GLYCOL 
NYLON-12 
DIMETHICONE 
GLYCERIN 
PEG-10 DIMETHICONE (600 CST) 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
TITANIUM DIOXIDE 
BARIUM SULFATE 
ALUMINUM HYDROXIDE 
PHENOXYETHANOL 
PALMITIC ACID 
STEARIC ACID 
EDETATE TRISODIUM 
DISTEARYLDIMONIUM CHLORIDE 
MICA 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
ISOPROPYL ALCOHOL 
GINKGO 
ROSA ROXBURGHII FRUIT 
.ALPHA.-TOCOPHEROL 
LILIUM CANDIDUM BULB 
Packaging
#Item CodePackage Description
1NDC:52685-339-601 TUBE (TUBE) in 1 CARTON
131.25 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2011
CLE DE PEAU BEAUTE FOUNDATION I   O10
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-340
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (Titanium dioxide) Titanium dioxide0.65625 g  in 31.25 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
TALC 
BUTYLENE GLYCOL 
NYLON-12 
DIMETHICONE 
GLYCERIN 
PEG-10 DIMETHICONE (600 CST) 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
TITANIUM DIOXIDE 
BARIUM SULFATE 
ALUMINUM HYDROXIDE 
PHENOXYETHANOL 
PALMITIC ACID 
STEARIC ACID 
EDETATE TRISODIUM 
DISTEARYLDIMONIUM CHLORIDE 
MICA 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
ISOPROPYL ALCOHOL 
GINKGO 
ROSA ROXBURGHII FRUIT 
.ALPHA.-TOCOPHEROL 
LILIUM CANDIDUM BULB 
Packaging
#Item CodePackage Description
1NDC:52685-340-601 TUBE (TUBE) in 1 CARTON
131.25 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2011
CLE DE PEAU BEAUTE FOUNDATION I   O20
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-341
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (Titanium dioxide) Titanium dioxide0.65625 g  in 31.25 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
TALC 
BUTYLENE GLYCOL 
NYLON-12 
DIMETHICONE 
GLYCERIN 
PEG-10 DIMETHICONE (600 CST) 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
TITANIUM DIOXIDE 
BARIUM SULFATE 
ALUMINUM HYDROXIDE 
PHENOXYETHANOL 
PALMITIC ACID 
STEARIC ACID 
EDETATE TRISODIUM 
DISTEARYLDIMONIUM CHLORIDE 
MICA 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
ISOPROPYL ALCOHOL 
GINKGO 
ROSA ROXBURGHII FRUIT 
.ALPHA.-TOCOPHEROL 
LILIUM CANDIDUM BULB 
Packaging
#Item CodePackage Description
1NDC:52685-341-601 TUBE (TUBE) in 1 CARTON
131.25 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2011
CLE DE PEAU BEAUTE FOUNDATION I   O30
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-342
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (Titanium dioxide) Titanium dioxide0.65625 g  in 31.25 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
TALC 
BUTYLENE GLYCOL 
NYLON-12 
DIMETHICONE 
GLYCERIN 
PEG-10 DIMETHICONE (600 CST) 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
TITANIUM DIOXIDE 
BARIUM SULFATE 
ALUMINUM HYDROXIDE 
PHENOXYETHANOL 
PALMITIC ACID 
STEARIC ACID 
EDETATE TRISODIUM 
DISTEARYLDIMONIUM CHLORIDE 
MICA 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
ISOPROPYL ALCOHOL 
GINKGO 
ROSA ROXBURGHII FRUIT 
.ALPHA.-TOCOPHEROL 
LILIUM CANDIDUM BULB 
Packaging
#Item CodePackage Description
1NDC:52685-342-601 TUBE (TUBE) in 1 CARTON
131.25 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2011
CLE DE PEAU BEAUTE FOUNDATION I   B10
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-343
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (Titanium dioxide) Titanium dioxide0.65625 g  in 31.25 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
TALC 
BUTYLENE GLYCOL 
NYLON-12 
DIMETHICONE 
GLYCERIN 
PEG-10 DIMETHICONE (600 CST) 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
TITANIUM DIOXIDE 
BARIUM SULFATE 
ALUMINUM HYDROXIDE 
PHENOXYETHANOL 
PALMITIC ACID 
STEARIC ACID 
EDETATE TRISODIUM 
DISTEARYLDIMONIUM CHLORIDE 
MICA 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
ISOPROPYL ALCOHOL 
GINKGO 
ROSA ROXBURGHII FRUIT 
.ALPHA.-TOCOPHEROL 
LILIUM CANDIDUM BULB 
Packaging
#Item CodePackage Description
1NDC:52685-343-601 TUBE (TUBE) in 1 CARTON
131.25 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2011
CLE DE PEAU BEAUTE FOUNDATION I   B20
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-344
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (Titanium dioxide) Titanium dioxide0.65625 g  in 31.25 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
TALC 
BUTYLENE GLYCOL 
NYLON-12 
DIMETHICONE 
GLYCERIN 
PEG-10 DIMETHICONE (600 CST) 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
TITANIUM DIOXIDE 
BARIUM SULFATE 
ALUMINUM HYDROXIDE 
PHENOXYETHANOL 
PALMITIC ACID 
STEARIC ACID 
EDETATE TRISODIUM 
DISTEARYLDIMONIUM CHLORIDE 
MICA 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
ISOPROPYL ALCOHOL 
GINKGO 
ROSA ROXBURGHII FRUIT 
.ALPHA.-TOCOPHEROL 
LILIUM CANDIDUM BULB 
Packaging
#Item CodePackage Description
1NDC:52685-344-601 TUBE (TUBE) in 1 CARTON
131.25 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2011
CLE DE PEAU BEAUTE FOUNDATION I   B30
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-345
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (Titanium dioxide) Titanium dioxide0.65625 g  in 31.25 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 
TALC 
BUTYLENE GLYCOL 
NYLON-12 
DIMETHICONE 
GLYCERIN 
PEG-10 DIMETHICONE (600 CST) 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
TITANIUM DIOXIDE 
BARIUM SULFATE 
ALUMINUM HYDROXIDE 
PHENOXYETHANOL 
PALMITIC ACID 
STEARIC ACID 
EDETATE TRISODIUM 
DISTEARYLDIMONIUM CHLORIDE 
MICA 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
ISOPROPYL ALCOHOL 
GINKGO 
ROSA ROXBURGHII FRUIT 
.ALPHA.-TOCOPHEROL 
LILIUM CANDIDUM BULB 
Packaging
#Item CodePackage Description
1NDC:52685-345-601 TUBE (TUBE) in 1 CARTON
131.25 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2011
Labeler - SHISEIDO CO., LTD. (690536453)
Establishment
NameAddressID/FEIOperations
SHISEIDO CO., LTD.695589382MANUFACTURE(52685-338, 52685-339, 52685-340, 52685-341, 52685-342, 52685-343, 52685-344, 52685-345), ANALYSIS(52685-338, 52685-339, 52685-340, 52685-341, 52685-342, 52685-343, 52685-344, 52685-345)

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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