SHISEIDO BENEFIANCE WRINKLERESIST24 DAY- avobenzone, octinoxate, and octocrylene emulsion

SHISEIDO BENEFIANCE WRINKLERESIST24 DAY by

Drug Labeling and Warnings

SHISEIDO BENEFIANCE WRINKLERESIST24 DAY by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICA INC., Davlyn Industries Inc. 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, SD ALCOHOL 40-B, DIPROPYLENE GLYCOL, XYLITOL, BUTYLENE GLYCOL, SILICA, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, HYDROGENATED POLYDECENE, PEG-60 GLYCERYL ISOSTEARATE, TRIISOSTEARIN, DIMETHICONE, DIPHENYLSILOXY PHENYL TRIMETHICONE, 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, STEARIC ACID, GLYCERYL STEARATE SE, BEHENYL ALCOHOL, ISOSTEARIC ACID, BEHENIC ACID, BEHENETH-20, TRIETHANOLAMINE, CELLULOSE GUM, DISODIUM EDTA, SODIUM METAPHOSPHATE, ALCOHOL, BHT, TOCOPHEROL, PHENOXYETHANOL, 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

SHISEIDO AMERICA INC.
NEW YORK, N.Y. 10022
SHISEIDO DIST.
NEW YORK PARIS MILANO

PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton

SHISEIDO

BENEFIANCE
WrinkleResist24

Day Emulsion

BROAD SPECTRUM
SPF 18

SUNSCREEN

75mL 2.5 FL. OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO BENEFIANCE WRINKLERESIST24 DAY 
avobenzone, octinoxate, and octocrylene emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-343
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1946 mg  in 77.85 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5761 mg  in 77.85 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1557 mg  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)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914)
TRIISOSTEARIN (UNII: 71503RH8KG)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
DOCOSANOL (UNII: 9G1OE216XY)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BEHENIC ACID (UNII: H390488X0A)
ISOSTEARIC ACID (UNII: X33R8U0062)
XANTHAN GUM (UNII: TTV12P4NEE)
BEHENETH-20 (UNII: BJ4GP2IFLN)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALCOHOL (UNII: 3K9958V90M)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SAPINDUS MUKOROSSI FRUIT RIND (UNII: 3D1P12PN9U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYDROXYPROLINE (UNII: RMB44WO89X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-343-10	1 in 1 CARTON	11/01/2012
1		77.85 g in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 58411-343-11	1 in 1 CARTON	11/01/2012
2		7.27 g in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 58411-343-12	1 in 1 CARTON	11/01/2012
3		15.57 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	11/01/2012

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(58411-343) , ANALYSIS(58411-343)