CLE DE PEAU BEAUTE SMOOTHING BASE FOR LINES- titanium dioxide cream 
SHISEIDO CO., LTD.

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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CLE DE PEAU BEAUTE SMOOTHING BASE FOR LINES

Drug Facts

Active ingredient

TITANIUM DIOXIDE 9.9%

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 • GLYCERIN • DIMETHICONE • POLYMETHYL METHACRYLATE • DIPROPYLENE GLYCOL • PEG-10 DIMETHICONE • XYLITOL • BUTYLENE GLYCOL • ERYTHRITOL • PEG-150 • ALUMINUM HYDROXIDE • ALUMINUM DISTEARATE • CETYL ETHYLHEXANOATE • BARIUM SULFATE • DISTEARDIMONIUM HECTORITE • OLEA EUROPAEA (OLIVE) FRUIT OIL • PHENOXYETHANOL • TRIMETHYLSILOXYSILICATE • ISOSTEARIC ACID • TRISODIUM EDTA • FRAGRANCE • IRON OXIDES • TOCOPHEROL • SYNTHETIC FLUORPHLOGOPITE • ALCOHOL • MICA • TALC • SODIUM ACETYLATED HYALURONATE • ROSA ROXBURGHII FRUIT EXTRACT • TRIETHOXYCAPRYLYLSILANE • CAMELLIA SINENSIS LEAF EXTRACT • TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE • PRUNUS SPECIOSA LEAF EXTRACT • DIMETHICONE/METHICONE COPOLYMER • TITANIUM DIOXIDE

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 - 34 mL Tube Carton

clé de peau
BEAUTÉ

smoothing base for lines

BROAD SPECTRUM SPF 26
SUNSCREEN

34mL NET WT. 1.3 OZ.

PRINCIPAL DISPLAY PANEL - 34 mL Tube Carton
CLE DE PEAU BEAUTE SMOOTHING BASE FOR LINES 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-192
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide3960 mg  in 40 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
XYLITOL (UNII: VCQ006KQ1E)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ERYTHRITOL (UNII: RA96B954X6)  
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
ALCOHOL (UNII: 3K9958V90M)  
MICA (UNII: V8A1AW0880)  
TALC (UNII: 7SEV7J4R1U)  
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-192-601 in 1 CARTON09/01/200803/01/2023
140 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/200803/01/2023
Labeler - SHISEIDO CO., LTD. (690536453)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO CO., LTD.695589382MANUFACTURE(52685-192) , ANALYSIS(52685-192)

Revised: 9/2023
 
SHISEIDO CO., LTD.