BENEFIANCE PROTECTIVE HAND REVITALIZER- octinoxate cream

BENEFIANCE PROTECTIVE HAND REVITALIZER by

Drug Labeling and Warnings

BENEFIANCE PROTECTIVE HAND REVITALIZER by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICA INC., Davlyn Industries Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OCTINOXATE 7.4%

Purpose

Sunscreen

Use

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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
• children under 6 months: Ask a doctor

Inactive Ingredients

WATER, DIPROPYLENE GLYCOL, DIMETHICONE, BUTYLENE GLYCOL, DIPHENYLSILOXY PHENYL TRIMETHICONE, STEARYL ALCOHOL, HYDROGENATED PALM OIL, PEG-5 GLYCERYL STEARATE, BENTONITE, GLYCERIN, SQUALANE, TRANEXAMIC ACID, TRIMETHYLSILOXYSILICATE, XANTHAN GUM, PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE, TOCOPHERYL ACETATE, POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE, MAGNESIUM ASCORBYL PHOSPHATE, SODIUM HYALURONATE, SAXIFRAGA SARMENTOSA EXTRACT, STEARIC ACID, ISOSTEARIC ACID, BEHENIC ACID, CYCLOMETHICONE, TRISODIUM EDTA, SODIUM CITRATE, POTASSIUM HYDROXIDE, ALCOHOL, BHT, TOCOPHEROL, PHENOXYETHANOL, ETHYLPARABEN, BUTYLPARABEN, 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

PRINCIPAL DISPLAY PANEL - 75g Tube Carton

SHISEIDO

Shiseido
Benefiance

Protective
Hand Revitalizer (Cream)
SPF 10
SUNSCREEN

75g NET WT. 2.6 OZ.

INGREDIENTS AND APPEARANCE

BENEFIANCE PROTECTIVE HAND REVITALIZER 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5550 mg  in 75 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
HYDROGENATED PALM OIL (UNII: 257THB963H)
PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
BENTONITE (UNII: A3N5ZCN45C)
GLYCERIN (UNII: PDC6A3C0OX)
SQUALANE (UNII: GW89575KF9)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
STEARIC ACID (UNII: 4ELV7Z65AP)
ISOSTEARIC ACID (UNII: X33R8U0062)
BEHENIC ACID (UNII: H390488X0A)
CYCLOMETHICONE (UNII: NMQ347994Z)
EDETATE TRISODIUM (UNII: 420IP921MB)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLPARABEN (UNII: 14255EXE39)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-106-60	1 in 1 CARTON
1		75 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/01/2012

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(52686-106) , ANALYSIS(52686-106)

Establishment
Name	Address	ID/FEI	Business Operations
Davlyn Industries Inc		624436254	MANUFACTURE(52686-106)