SENSAI BG63

Dosage form: gel
Ingredients: OCTINOXATE 3.5g in 100mL, TITANIUM DIOXIDE 0.89g in 100mL
Labeler: KANEBO COSMETICS INC.
NDC Code: 64159-7048

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 BRONZING GEL BG63
SPF6

ACTIVE INGREDIENTS

OCTINOXATE 3.5% Sunscreen

TITANIUM DIOXIDE 0.89% Sunscreen

INGREDIENTS

WATER (AQUA), ALCOHOL, ETHYLHEXYL METHOXYCINNAMATE, BUTYLENE GLYCOL, CYCLOMETHICONE, TITANIUM DIOXIDE, SORBITAN ISOSTEARATE, AMINOMETHYL PROPANOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CARBOMER, SQUALANE, AMMONIUM GLYCYRRHIZATE, MACADAMIA TERNIFOLIA SEED OIL, DISODIUM EDTA, FRAGRANCE (PARFUM), XANTHAN GUM, HYDROLYZED SILK, BHT, METHICONE, HYDROLYZED RICE EXTRACT, OCTYLDODECYL LACTATE, STEARIC ACID, MYRISTIC ACID, TOCOPHEROL, METHYLPARABEN, ETHYLPARABEN, BUTYLPARABEN, [MAY CONTAIN(+/-): ALUMINA, IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), LAUROYL LYSINE, MICA (CI 77019), SYNTHETIC FLUORPHLOGOPITE, TALC

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

  • a skin rash occurs.

Keep out of reach of children.

WARNING: Keep out of the eyes. Discontinue use if irritation appears.

DIST.: Kanebo Cosmetics USA LLC
330 Madison Avenue,
New York, NY 10017

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

SENSAI

SPF 6

BRONZING GEL

Kanebo
INTERNATIONAL

NET WT. 1.7 OZ. 50mL e

SENSAI   BG63
octinoxate and titanium dioxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64159-7048
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE3.5 g  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.89 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
BUTYLENE GLYCOL 
CYCLOMETHICONE 
SORBITAN ISOSTEARATE 
AMINOMETHYLPROPANOL 
SQUALANE 
AMMONIUM GLYCYRRHIZATE 
MACADAMIA OIL 
EDETATE DISODIUM 
XANTHAN GUM 
BUTYLATED HYDROXYTOLUENE 
OCTYLDODECYL LACTATE 
STEARIC ACID 
MYRISTIC ACID 
TOCOPHEROL 
METHYLPARABEN 
ETHYLPARABEN 
BUTYLPARABEN 
ALUMINUM OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
LAUROYL LYSINE 
MICA 
TALC 
Packaging
#Item CodePackage Description
1NDC:64159-7048-150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35202/01/201005/14/2015
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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