SENSAI CELLULAR PERFORMANCE INTENSIVE HAND TREATMENT

Dosage form: gel
Ingredients: OCTINOXATE 3g in 100mL
Labeler: KANEBO COSMETICS INC
NDC Code: 64159-6208

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.

SENSAI
CELLULAR PERFORMANCE
SPF 8
INTENSIVE
HAND TREATMENT

Direction

Apply liberally and evenly before sun exposure and as needed.

Use helps prevent sunburn.

Apply and reapply as directed to avoid lowering protection.

Warning

Stop use and ask a doctor if

  • skin rash occurs.

Keep out of reach of children.

ACTIVE INGREDIENTS

OCTINOXATE (ETHYLHEXYL METHOXYCINNAMATE) 3% Sunscreen

INGREDIENTS

WATER (AQUA), SQUALANE, OCTYLDODECYL MYRISTATE, DIPROPYLENE GLYCOL, ETHYLHEXYL METHOXYCINNAMATE, CETYL ALCOHOL, GLYCERYL STEARATE SE, HYDROGENATED CASTOR OIL ISOSTEARATE, NIACINAMIDE, PEG-2 STEARATE, PHYTOSTERYL MACADAMIATE, SODIUM CETYL SULFATE, BEESWAX (CERA ALBA), DIMETHICONE, GLYCERYL STEARATE, CHOLESTEROL, DIPOTASSIUM GLYCYRRHIZATE, GLYCERIN, METHYLSERINE, PRUNUS ARMENIACA (APRICOT) JUICE, BUTYLENE GLYCOL, DISODIUM EDTA, FRAGRANCE (PARFUM), ALCOHOL, DIMETHOXY DI-p-CRESOL, PYRACANTHA FORTUNEANA FRUIT EXTRACT, HYDROLYZED SILK, BHT, BLETILLA STRIATA ROOT EXTRACT, PRUNUS ARMENIACA (APRICOT) KERNEL EXTRACT, HYDROLYZED CONCHIOLIN PROTEIN, METHYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, BUTYLPARABEN, ALPHAISOMETHYL IONONE, CITRONELLOL, HEXYL CINNAMAL, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, LIMONENE, LINALOOL, RED 4 (CI 14700), YELLOW 5 (CI 19140)

DIST.: KANEBO COSMETICS USA LLC
330 Madison Avenue, New York, NY 10017

PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton

SENSAI
CELLULAR PERFORMANCE

SPF 8

INTENSIVE
HAND TREATMENT

Kanebo
INTERNATIONAL

NET WT. 3.5 OZ. 100mL e

SENSAI CELLULAR PERFORMANCE INTENSIVE HAND TREATMENT 
octinoxate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64159-6208
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SQUALANE 
DIPROPYLENE GLYCOL 
CETYL ALCOHOL 
NIACINAMIDE 
SODIUM CETYL SULFATE 
YELLOW WAX 
DIMETHICONE 
GLYCERYL MONOSTEARATE 
CHOLESTEROL 
GLYCYRRHIZINATE DIPOTASSIUM 
GLYCERIN 
APRICOT 
BUTYLENE GLYCOL 
EDETATE DISODIUM 
ALCOHOL 
BUTYLATED HYDROXYTOLUENE 
PRUNUS ARMENIACA SEED 
METHYLPARABEN 
ETHYLPARABEN 
PROPYLPARABEN 
BUTYLPARABEN 
.BETA.-CITRONELLOL, (R)- 
LINALOOL, (+/-)- 
FD&C RED NO. 4 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:64159-6208-1100 mL in 1 TUBE
2NDC:64159-6208-27 mL in 1 TUBE
3NDC:64159-6208-320 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35207/01/200702/05/2015
Labeler - KANEBO COSMETICS INC (691041271)

Revised: 10/2014
 
KANEBO COSMETICS INC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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