CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES- octinoxate and titanium dioxide cream

CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES by is a Otc medication manufactured, distributed, or labeled by SHISEIDO CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients		Purpose
OCTINOXATE	2.9%	Sunscreen
TITANIUM DIOXIDE	5.8%	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 DIPROPYLENE GLYCOL POLYMETHYLSILSESQUIOXANE PEG-10 DIMETHICONE GLYCERIN DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER CETYL ETHYLHEXANOATE SILICA DISTEARDIMONIUM HECTORITE BARIUM SULFATE ALUMINUM HYDROXIDE ALUMINUM DISTEARATE ISOSTEARIC ACID VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER PHENOXYETHANOL TRISODIUM EDTA METHYLPARABEN ETHYLPARABEN IRON OXIDES FRAGRANCE TRIMETHYLSILOXYSILICATE BUTYLENE GLYCOL SYNTHETIC FLUORPHLOGOPITE ALCOHOL BHT POLYSILICONE-2 ROSA ROXBURGHII FRUIT EXTRACT SODIUM ACETYLATED HYALURONATE TOCOPHEROL CAMELLIA SINENSIS LEAF EXTRACT TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL DIMETHICONE

Other information

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

Questions or comments?

Call toll free 1-800-906-7503

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

PRINCIPAL DISPLAY PANEL - 37 mL Tube Carton

clé de peau
BEAUTÉ

smoothing base for pores

BROAD SPECTRUM SPF 20
SUNSCREEN

37mL NET WT. 1.4 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE SMOOTHING BASE FOR PORES 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-191
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	1160 mg  in 40 g
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	2320 mg  in 40 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BARIUM SULFATE (UNII: 25BB7EKE2E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ISOSTEARIC ACID (UNII: X33R8U0062)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE TRISODIUM (UNII: 420IP921MB)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-191-60	1 in 1 CARTON
1		40 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2008

Labeler - SHISEIDO CO., LTD. (690536453)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO CO., LTD.		695589382	MANUFACTURE(52685-191) , ANALYSIS(52685-191)