CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER- ensulizole and octinoxate cream

CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER by is a Otc medication manufactured, distributed, or labeled by SHISEIDO CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
ENSULIZOLE 2.0%	Sunscreen
OCTINOXATE 4.9%	Sunscreen

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection

Warnings

For external use only

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply generously before sun exposure and as needed.
• apply and reapply as directed to avoid lowering protection.
• apply to all skin exposed to the sun.
• children under 6 months of age: ask a doctor

Inactive ingredients

WATER, GLYCERIN, BUTYLENE GLYCOL, CYCLOMETHICONE, DIPROPYLENE GLYCOL, SILICA, DIMETHICONE, TRIETHYLHEXANOIN, DIPHENYLSILOXY PHENYL TRIMETHICONE, BEHENYL ALCOHOL, BEHENETH-20, TRIETHANOLAMINE, METHYL AMINOMETHYLCYCLOHEXANE CARBOXAMIDE HCl, XANTHAN GUM, TOCOPHERYL ACETATE, SODIUM HYALURONATE, SODIUM ACETYLATED HYALURONATE, LAURYL BETAINE, BUPLEURUM FALCATUM ROOT EXTRACT, UNCARIA GAMBIR EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, STEARYL ALCOHOL, SODIUM METAPHOSPHATE, CELLULOSE GUM, TRISODIUM EDTA, ALUMINUM HYDROXIDE, ISOSTEARIC ACID, BHT, ALCOHOL, TOCOPHEROL, PHENOXYETHANOL, SODIUM BENZOATE, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES

Questions?

1-800-906-7503

SPL UNCLASSIFIED SECTION

Distributed by
SHISEIDO COSMETICS (AMERICA) LTD.
NEW YORK, NY 10022

PRINCIPAL DISPLAY PANEL - 20mL Bottle Carton

SYNACTIF

Daytime moisturizer
SPF 17 sunscreen

20mL NET WT. .75 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER 
ensulizole and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-380
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	430 mg  in 21.52 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	1054 mg  in 21.52 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
DOCOSANOL (UNII: 9G1OE216XY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TROLAMINE (UNII: 9O3K93S3TK)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ISOSTEARIC ACID (UNII: X33R8U0062)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
LAURYL BETAINE (UNII: Y4P927Q133)
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-380-10	1 in 1 CARTON
1		21.52 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	11/01/2009

Labeler - SHISEIDO CO., LTD. (690536453)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO CO., LTD.		695087684	MANUFACTURE(52685-380) , ANALYSIS(52685-380)