BENEFIANCE PROTECTIVE HAND REVITALIZER- octinoxate cream 
SHISEIDO AMERICA INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BENEFIANCE PROTECTIVE HAND REVITALIZER

Drug Facts

Active ingredient

OCTINOXATE 7.4%

Purpose

Sunscreen

Use

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:

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

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.

PRINCIPAL DISPLAY PANEL - 75g Tube Carton
BENEFIANCE PROTECTIVE HAND REVITALIZER 
octinoxate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52686-106
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 9/2012
Document Id: d73e6a8d-018b-404c-b626-97738c62cec8
Set id: 4d2f3a56-60f6-4230-a19c-7216eaffbb1f
Version: 1
Effective Time: 20120917
 
SHISEIDO AMERICA INC.