SHISEIDO BENEFIANCE WRINKLERESIST24 DAY- octinoxate and octocrylene emulsion

SHISEIDO by

Drug Labeling and Warnings

SHISEIDO by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
OCTINOXATE 4.9%	Sunscreen
OCTOCRYLENE 5.0%	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 smoothly to face before sun exposure and as needed.
• children under 6 months of age: ask a doctor.

Inactive Ingredients

WATER, GLYCERIN, DIPROPYLENE GLYCOL, SD ALCOHOL 40-B, XYLITOL, BUTYLENE GLYCOL, SILICA, PHENYL TRIMETHICONE, HYDROGENATED POLYDECENE, PEG-60 GLYCERYL ISOSTEARATE, DIMETHICONE, XANTHAN GUM, PEG/PPG-17/4 DIMETHYL ETHER, PHYTOSTERYL MACADAMIATE, TOCOPHERYL ACETATE, SAPINDUS MUKUROSSI PEEL EXTRACT, UNCARIA GAMBIR EXTRACT, SODIUM ACETYLATED HYALURONATE, HYDROXYPROLINE, THYMUS SERPILLUM EXTRACT, CHLORELLA VULGARIS EXTRACT, BUTYL METHOXYDIBENZOYLMETHANE, BEHENYL ALCOHOL, GLYCERYL STEARATE SE, STEARIC ACID, ISOSTEARIC ACID, BEHENIC ACID, BEHENETH-20, TRIETHANOLAMINE, CELLULOSE GUM, SODIUM METAPHOSPHATE, DISODIUM EDTA, ALCOHOL, BHT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, IRON OXIDES

Questions?

1-800-906-7503

PRINCIPAL DISPLAY PANEL - 75mL Bottle Carton

SHI SEIDO

BENEFIANCE
WrinkleResist24

Day Emulsion
SPF 15 PA++
SUNSCREEN

75mL 2.5 FL. OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO  BENEFIANCE WRINKLERESIST24 DAY
octinoxate and octocrylene emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-231
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.81465 g  in 77.85 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3.8925 g  in 77.85 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
XYLITOL (UNII: VCQ006KQ1E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DIMETHICONE (UNII: 92RU3N3Y1O)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
HYDROXYPROLINE (UNII: RMB44WO89X)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
AVOBENZONE (UNII: G63QQF2NOX)
DOCOSANOL (UNII: 9G1OE216XY)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
ISOSTEARIC ACID (UNII: X33R8U0062)
DOCOSANOIC ACID, 1-(((1-OXODECYL)OXY)METHYL)-2-((1-OXOOCTYL)OXY)ETHYL ESTER, (+/-)- (UNII: 8721C76X6A)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-231-10	1 in 1 CARTON	02/01/2011
1		77.85 g 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	02/01/2011

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(52686-231) , analysis(52686-231)