SHISEIDO BENEFIANCE WRINKLERESIST24 DAY- octinoxate and octocrylene cream

SHISEIDO BENEFIANCE WRINKLERESIST24 DAY by

Drug Labeling and Warnings

SHISEIDO BENEFIANCE WRINKLERESIST24 DAY 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, BUTYLENE GLYCOL, PHENYL TRIMETHICONE, HYDROGENATED POLYDECENE, SORBITOL, MYRISTYL MYRISTATE, DIMETHICONE, SD ALCOHOL 40-B, PETROLATUM, STEARYL ALCOHOL, STEARIC ACID, SILICA, PALMITIC ACID, 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, PEG-5 GLYCERYL STEARATE, GLYCERYL STEARATE SE, BUTYL METHOXYDIBENZOYLMETHANE, BENTONITE, TRISODIUM EDTA, POTASSIUM HYDROXIDE, SODIUM METAPHOSPHATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, ALCOHOL, SODIUM METABISULFITE, BHT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, IRON OXIDES

Questions?

1-800-906-7503

PRINCIPAL DISPLAY PANEL - 50mL Carton

SHI SEIDO

BENEFIANCE
WrinkleResist24

Day Cream
SPF 15 PA++
SUNSCREEN

50mL NET WT. 1.8 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO BENEFIANCE WRINKLERESIST24 DAY 
octinoxate and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-230
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.51125 g  in 51.25 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.5625 g  in 51.25 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SORBITOL (UNII: 506T60A25R)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
DIMETHICONE (UNII: 92RU3N3Y1O)
PETROLATUM (UNII: 4T6H12BN9U)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PALMITIC ACID (UNII: 2V16EO95H1)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
AVOBENZONE (UNII: G63QQF2NOX)
BENTONITE (UNII: A3N5ZCN45C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE TRISODIUM (UNII: 420IP921MB)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ALCOHOL (UNII: 3K9958V90M)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYDROXYPROLINE (UNII: RMB44WO89X)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-230-50	1 in 1 CARTON	02/01/2011
1		51.25 g in 1 JAR; 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(52686-230) , analysis(52686-230)