CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER- avobenzone, octinoxate, and octocrylene 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
AVOBENZONE 2.5%	Sunscreen
OCTINOXATE 7.4%	Sunscreen
OCTOCRYLENE 2.0%	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, GLYCERIN, BUTYLENE GLYCOL, DIMETHICONE, DIPROPYLENE GLYCOL, SILICA, DIISOPROPYL SEBACATE, TRIETHYLHEXANOIN, DIPHENYLSILOXY PHENYL TRIMETHICONE, BEHENYL ALCOHOL, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, BEHENETH-20, 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, CELLULOSE GUM, SODIUM METAPHOSPHATE, TRISODIUM EDTA, ISOSTEARIC ACID, BHT, ALCOHOL, TOCOPHEROL, PHENOXYETHANOL, SODIUM BENZOATE, FRAGRANCE, 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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 20mL Jar Carton

SYNACTIF

Daytime moisturizer
BROAD SPECTRUM SPF 18 SUNSCREEN

20mL NET WT. .73 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER 
avobenzone, octinoxate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-463
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	523 mg  in 20.92 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1548 mg  in 20.92 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	418 mg  in 20.92 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
DOCOSANOL (UNII: 9G1OE216XY)
BEHENETH-20 (UNII: BJ4GP2IFLN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
METHYL AMINOMETHYLCYCLOHEXANE CARBOXAMIDE HYDROCHLORIDE (UNII: ZV6O50F5CP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
EDETATE TRISODIUM (UNII: 420IP921MB)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOSTEARIC ACID (UNII: X33R8U0062)
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: 52685-463-50	1 in 1 CARTON
1		20.92 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2009

Labeler - SHISEIDO CO., LTD. (690536453)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO CO., LTD.		695087684	MANUFACTURE(52685-463) , ANALYSIS(52685-463)