Your browser does not support JavaScript! BENEFIANCE PROTECTIVE HAND REVITALIZER (OCTINOXATE) CREAM [SHISEIDO AMERICA INC.]
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BENEFIANCE PROTECTIVE HAND REVITALIZER (octinoxate) cream
[SHISEIDO AMERICA INC.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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.

PRINCIPAL DISPLAY PANEL - 75g Tube Carton
BENEFIANCE PROTECTIVE HAND REVITALIZER 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52686-106
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE5550 mg  in 75 g
Inactive Ingredients
Ingredient NameStrength
WATER 
DIPROPYLENE GLYCOL 
DIMETHICONE 
BUTYLENE GLYCOL 
DIPHENYLSILOXY PHENYL TRIMETHICONE 
STEARYL ALCOHOL 
HYDROGENATED PALM OIL 
PEG-5 GLYCERYL STEARATE 
BENTONITE 
GLYCERIN 
SQUALANE 
TRANEXAMIC ACID 
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) 
XANTHAN GUM 
.ALPHA.-TOCOPHEROL ACETATE 
POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE 
MAGNESIUM ASCORBYL PHOSPHATE 
HYALURONATE SODIUM 
SAXIFRAGA STOLONIFERA LEAF 
STEARIC ACID 
ISOSTEARIC ACID 
BEHENIC ACID 
CYCLOMETHICONE 
EDETATE TRISODIUM 
SODIUM CITRATE 
POTASSIUM HYDROXIDE 
ALCOHOL 
BUTYLATED HYDROXYTOLUENE 
TOCOPHEROL 
PHENOXYETHANOL 
ETHYLPARABEN 
BUTYLPARABEN 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52686-106-601 in 1 CARTON
175 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/01/2012
Labeler - SHISEIDO AMERICA INC. (782677132)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132MANUFACTURE(52686-106), ANALYSIS(52686-106)
Establishment
NameAddressID/FEIBusiness Operations
Davlyn Industries Inc624436254MANUFACTURE(52686-106)

Revised: 9/2012
 
SHISEIDO AMERICA INC.

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