SHISEIDO BENEFIANCE WRINKLERESIST24 PROTECTIVE HAND REVITALIZER- avobenzone, octinoxate, octocrylene, and oxybenzone cream

SHISEIDO BENEFIANCE WRINKLERESIST24 PROTECTIVE HAND REVITALIZER by

Drug Labeling and Warnings

SHISEIDO BENEFIANCE WRINKLERESIST24 PROTECTIVE HAND REVITALIZER 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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
AVOBENZONE 2.5%	Sunscreen
OCTINOXATE 4.9%	Sunscreen
OCTOCRYLENE 5.0%	Sunscreen
OXYBENZONE 1.5%	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

WATERGLYCERINDIPROPYLENE GLYCOLCAPRYLIC/CAPRIC TRIGLYCERIDEBEHENYL ALCOHOLBUTYLENE GLYCOLISOHEXADECANESD ALCOHOL 40-BSORBITOLSILICAMYRISTYL MYRISTATEDIMETHICONEPOLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMERSTEARYL ALCOHOLTRIISOSTEARINPHYTOSTERYL MACADAMIATETOCOPHERYL ACETATE2-O-ETHYL ASCORBIC ACIDPOTASSIUM ASCORBYL TOCOPHERYL PHOSPHATEARGININE HClSAXIFRAGA SARMENTOSA EXTRACTSAPINDUS MUKUROSSI PEEL EXTRACTPANAX GINSENG ROOT EXTRACTANGELICA ACUTILOBA ROOT EXTRACTSODIUM ACETYLATED HYALURONATEHYDROXYPROLINEUNCARIA GAMBIR EXTRACTCHLORELLA VULGARIS EXTRACTTHYMUS SERPILLUM EXTRACTBEHENETH-20ALCOHOLSUCCINOGLYCANTRISODIUM EDTASODIUM CITRATESODIUM METAPHOSPHATECITRIC ACIDBHTSODIUM METABISULFITETOCOPHEROLPHENOXYETHANOLFRAGRANCEIRON 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

PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton

SHI SEIDO

BENEFIANCE
WrinkleResist24

Protective
Hand Revitalizer

BROAD SPECTRUM
SPF 15

SUNSCREEN

75mL NET WT. 2.6 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO BENEFIANCE WRINKLERESIST24 PROTECTIVE HAND REVITALIZER 
avobenzone, octinoxate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-255
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1922 mg  in 75 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3767 mg  in 75 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3844 mg  in 75 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1153 mg  in 75 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DOCOSANOL (UNII: 9G1OE216XY)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOHEXADECANE (UNII: 918X1OUF1E)
SORBITOL (UNII: 506T60A25R)
DIMETHICONE (UNII: 92RU3N3Y1O)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TRIISOSTEARIN (UNII: 71503RH8KG)
BEHENETH-20 (UNII: BJ4GP2IFLN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALCOHOL (UNII: 3K9958V90M)
EDETATE TRISODIUM (UNII: 420IP921MB)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
SAPINDUS MUKOROSSI FRUIT RIND (UNII: 3D1P12PN9U)
FERRIC OXIDE RED (UNII: 1K09F3G675)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
ASIAN GINSENG (UNII: CUQ3A77YXI)
HYDROXYPROLINE (UNII: RMB44WO89X)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-255-60	1 in 1 CARTON	09/01/2015
1		75 mL in 1 TUBE; 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	09/01/2015

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-255) , analysis(58411-255)