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SENSAI

KANEBO COSMETICS INC.

SENSAI BRONZING GEL BG62 SPF6


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 GLYCYBRHIZATE, 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 LYSANE, MICA (CI 77019), SYNTHETIC FLUORPHLOCOPITE 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

  • 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

SENSAI

OCTINOXATE and TITANIUM DIOXIDE GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64159-7047
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 3.5 g
titanium dioxide 0.89 g

Inactive Ingredients

Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:64159-7047-1 50 in 1 TUBE
2 NDC:64159-7047-2 10 in 1 TUBE
3 NDC:64159-7047-3 2 in 1 TUBE
4 NDC:64159-7047-4 3.5 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2010-02-01


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