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

CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER n by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE SYNACTIF DAYTIME MOISTURIZER n by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Other information

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

Inactive Ingredients

WATER∙XYLITOL∙DIPROPYLENE GLYCOL∙GLYCERIN∙SD ALCOHOL 40-B∙DIPHENYLSILOXY PHENYL TRIMETHICONE∙ISODODECANE∙SILICA∙TRIETHYLHEXANOIN∙HYDROGENATED POLYDECENE∙PPG-17∙DIMETHICONE∙METHYL AMINOMETHYLCYCLOHEXANE CARBOXAMIDE HCl∙XANTHAN GUM∙TOCOPHERYL ACETATE∙PEG/PPG-14/7 DIMETHYL ETHER∙PHYTOSTERYL MACADAMIATE∙GLYCYL GLYCINE∙SODIUM ACETYLATED HYALURONATE∙SODIUM HYALURONATE∙LAURYL BETAINE∙NUPHAR JAPONICUM ROOT EXTRACT∙BUPLEURUM FALCATUM ROOT EXTRACT∙GINKGO BILOBA LEAF EXTRACT∙CAMELLIA SINENSIS LEAF EXTRACT∙BEHENETH-20∙BEHENYL ALCOHOL∙HYDROGENATED PALM OIL∙ELAEIS GUINEENSIS (PALM) KERNEL OIL∙STEARYL ALCOHOL∙ELAEIS GUINEENSIS (PALM) OIL∙BUTYLENE GLYCOL∙ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER∙CARBOMER∙PEG-10 DIMETHICONE∙POTASSIUM HYDROXIDE∙CELLULOSE GUM∙SODIUM METAPHOSPHATE∙ALCOHOL∙DISODIUM EDTA∙BHT∙ISOSTEARIC ACID∙CINNAMOMUM CASSIA BARK EXTRACT∙TOCOPHEROL∙CITRIC ACID∙PHENOXYETHANOL∙SODIUM BENZOATE∙FRAGRANCE∙IRON OXIDES∙

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 20 mL Bottle Carton

SYNACTIF

Daytime
moisturizer

BROAD SPECTRUM
SPF 19
SUNSCREEN

20mL .67 FL. OZ.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-237
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	518 mg  in 20 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1532 mg  in 20 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	414 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PALM OIL (UNII: 5QUO05548Z)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
ALCOHOL (UNII: 3K9958V90M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOSTEARIC ACID (UNII: X33R8U0062)
CHINESE CINNAMON (UNII: WS4CQ062KM)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
ISODODECANE (UNII: A8289P68Y2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
PPG-17 (UNII: OV0Q322E0U)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYL AMINOMETHYLCYCLOHEXANE CARBOXAMIDE HYDROCHLORIDE (UNII: ZV6O50F5CP)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
DIGLYCINE (UNII: 10525P22U0)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LAURYL BETAINE (UNII: Y4P927Q133)
NUPHAR JAPONICA ROOT (UNII: 3OPM78C6RQ)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
GINKGO (UNII: 19FUJ2C58T)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BEHENETH-20 (UNII: BJ4GP2IFLN)
DOCOSANOL (UNII: 9G1OE216XY)
HYDROGENATED PALM OIL (UNII: 257THB963H)
PALM KERNEL OIL (UNII: B0S90M0233)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-237-10	1 in 1 CARTON	10/01/2014
1		20 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2014

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-237) , analysis(58411-237)