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SENSAI FLUID FINISH FF102

Dosage form: liquid
Ingredients: TITANIUM DIOXIDE 4.5g in 100mL, OCTINOXATE 3g in 100mL
Labeler: KANEBO COSMETICS INC
NDC Code: 64159-6969

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
FLUID FINISH
SPF 15

ACTIVE INGREDIENTS

Octinoxate 3.0% Sunscreen
Titanium Dioxide 4.5% Sunscreen

INGREDIENTS: WATER (AQUA), CYCLOMETHICONE, MINERAL OIL (PARAFFINUM LIQUIDUM), TITANIUM DIOXIDE, MALTITOL, GLYCERIN, ETHYLHEXYL METHOXYCINNAMATE, DIPROPYLENE GLYCOL, PETROLATUM, SORBITAN ISOSTEARATE, PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE, DIMETHICONE COPOLYOL, DIISOSTEARYL MALATE, SQUALANE, TRIBEHENIN, HYDROGENATED LECITHIN, FRAGRANCE (PARFUM), ALCOHOL, HYDROLYZED SILK, BHT, METHICONE, HYDROLYZED RICE EXTRACT, OCTYLDODECYL LACTATE, STEARIC ACID, MYRISTIC ACID, TOCOPHEROL, SILK POWDER (SERICA), PHENOXYETHANOL, SORBIC ACID, METHYLPARABEN, ETHYlPARABEN, BUTYLPARABEN, [MAY CONTAIN(+/-): IRON OXIDES (CI 77491), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), 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

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 - 30 mL Tube Carton

SENSAI

SPF 15

FLUID FINISH

Kanebo
INTERNATIONAL

NET 1.02 FL.OZ. 30mL e

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

SENSAI

SPF 15

FLUID FINISH

Kanebo
INTERNATIONAL

NET 1.02 FL.OZ. 30mL e

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

SENSAI

SPF 15

FLUID FINISH

Kanebo
INTERNATIONAL

NET 1.02 FL.OZ. 30mL e

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

SENSAI

SPF 15

FLUID FINISH

Kanebo
INTERNATIONAL

NET 1.02 FL.OZ. 30mL e

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

SENSAI

SPF 15

FLUID FINISH

Kanebo
INTERNATIONAL

NET 1.02 FL.OZ. 30mL e

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

SENSAI

SPF 15

FLUID FINISH

Kanebo
INTERNATIONAL

NET 1.02 FL.OZ. 30mL e

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

SENSAI

SPF 15

FLUID FINISH

Kanebo
INTERNATIONAL

NET 1.02 FL.OZ. 30mL e

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

SENSAI

SPF 15

FLUID FINISH

Kanebo
INTERNATIONAL

NET 1.02 FL.OZ. 30mL e

SENSAI FLUID FINISH FF102
titanium dioxide and octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64159-6969
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	4.5 g in 100 mL
OCTINOXATE (OCTINOXATE)	OCTINOXATE	3 g in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
CYCLOMETHICONE
MINERAL OIL
MALTITOL
GLYCERIN
DIPROPYLENE GLYCOL
PETROLATUM
SORBITAN ISOSTEARATE
DIISOSTEARYL MALATE
SQUALANE
TRIBEHENIN
ALCOHOL
BUTYLATED HYDROXYTOLUENE
OCTYLDODECYL LACTATE
STEARIC ACID
MYRISTIC ACID
TOCOPHEROL
PHENOXYETHANOL
SORBIC ACID
METHYLPARABEN
ETHYLPARABEN
BUTYLPARABEN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
TALC

Packaging
#	Item Code	Package Description
1	NDC:64159-6969-1	30 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/01/2008

SENSAI FLUID FINISH FF103
titanium dioxide and octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64159-6970
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	4.5 g in 100 mL
OCTINOXATE (OCTINOXATE)	OCTINOXATE	3 g in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
CYCLOMETHICONE
MINERAL OIL
MALTITOL
GLYCERIN
DIPROPYLENE GLYCOL
PETROLATUM
SORBITAN ISOSTEARATE
DIISOSTEARYL MALATE
SQUALANE
TRIBEHENIN
ALCOHOL
BUTYLATED HYDROXYTOLUENE
OCTYLDODECYL LACTATE
STEARIC ACID
MYRISTIC ACID
TOCOPHEROL
PHENOXYETHANOL
SORBIC ACID
METHYLPARABEN
ETHYLPARABEN
BUTYLPARABEN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
TALC

Packaging
#	Item Code	Package Description
1	NDC:64159-6970-1	30 mL in 1 BOTTLE, GLASS
2	NDC:64159-6970-2	2 mL in 1 BOTTLE, PLASTIC
3	NDC:64159-6970-3	1 mL in 1 POUCH
4	NDC:64159-6970-4	10 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/01/2008

SENSAI FLUID FINISH FF202
titanium dioxide and octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64159-6971
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	4.5 g in 100 mL
OCTINOXATE (OCTINOXATE)	OCTINOXATE	3 g in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
CYCLOMETHICONE
MINERAL OIL
MALTITOL
GLYCERIN
DIPROPYLENE GLYCOL
PETROLATUM
SORBITAN ISOSTEARATE
DIISOSTEARYL MALATE
SQUALANE
TRIBEHENIN
ALCOHOL
BUTYLATED HYDROXYTOLUENE
OCTYLDODECYL LACTATE
STEARIC ACID
MYRISTIC ACID
TOCOPHEROL
PHENOXYETHANOL
SORBIC ACID
METHYLPARABEN
ETHYLPARABEN
BUTYLPARABEN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
TALC

Packaging
#	Item Code	Package Description
1	NDC:64159-6971-1	30 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/01/2008

SENSAI FLUID FINISH FF203
titanium dioxide and octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64159-6972
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	4.5 g in 100 mL
OCTINOXATE (OCTINOXATE)	OCTINOXATE	3 g in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
CYCLOMETHICONE
MINERAL OIL
MALTITOL
GLYCERIN
DIPROPYLENE GLYCOL
PETROLATUM
SORBITAN ISOSTEARATE
DIISOSTEARYL MALATE
SQUALANE
TRIBEHENIN
ALCOHOL
BUTYLATED HYDROXYTOLUENE
OCTYLDODECYL LACTATE
STEARIC ACID
MYRISTIC ACID
TOCOPHEROL
PHENOXYETHANOL
SORBIC ACID
METHYLPARABEN
ETHYLPARABEN
BUTYLPARABEN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
TALC

Packaging
#	Item Code	Package Description
1	NDC:64159-6972-1	30 mL in 1 BOTTLE, GLASS
2	NDC:64159-6972-2	10 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/01/2008

SENSAI FLUID FINISH FF204
titanium dioxide and octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64159-6973
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	4.5 g in 100 mL
OCTINOXATE (OCTINOXATE)	OCTINOXATE	3 g in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
CYCLOMETHICONE
MINERAL OIL
MALTITOL
GLYCERIN
DIPROPYLENE GLYCOL
PETROLATUM
SORBITAN ISOSTEARATE
DIISOSTEARYL MALATE
SQUALANE
TRIBEHENIN
ALCOHOL
BUTYLATED HYDROXYTOLUENE
OCTYLDODECYL LACTATE
STEARIC ACID
MYRISTIC ACID
TOCOPHEROL
PHENOXYETHANOL
SORBIC ACID
METHYLPARABEN
ETHYLPARABEN
BUTYLPARABEN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
TALC

Packaging
#	Item Code	Package Description
1	NDC:64159-6973-1	30 mL in 1 BOTTLE, GLASS
2	NDC:64159-6973-2	2 mL in 1 BOTTLE, PLASTIC
3	NDC:64159-6973-3	1 mL in 1 POUCH
4	NDC:64159-6973-4	10 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/01/2008

SENSAI FLUID FINISH FF204.5
titanium dioxide and octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64159-6974
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	4.5 g in 100 mL
OCTINOXATE (OCTINOXATE)	OCTINOXATE	3 g in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
CYCLOMETHICONE
MINERAL OIL
MALTITOL
GLYCERIN
DIPROPYLENE GLYCOL
PETROLATUM
SORBITAN ISOSTEARATE
DIISOSTEARYL MALATE
SQUALANE
TRIBEHENIN
ALCOHOL
BUTYLATED HYDROXYTOLUENE
OCTYLDODECYL LACTATE
STEARIC ACID
MYRISTIC ACID
TOCOPHEROL
PHENOXYETHANOL
SORBIC ACID
METHYLPARABEN
ETHYLPARABEN
BUTYLPARABEN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
TALC

Packaging
#	Item Code	Package Description
1	NDC:64159-6974-1	30 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/01/2008

SENSAI FLUID FINISH FF205
titanium dioxide and octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64159-6975
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	4.5 g in 100 mL
OCTINOXATE (OCTINOXATE)	OCTINOXATE	3 g in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
CYCLOMETHICONE
MINERAL OIL
MALTITOL
GLYCERIN
DIPROPYLENE GLYCOL
PETROLATUM
SORBITAN ISOSTEARATE
DIISOSTEARYL MALATE
SQUALANE
TRIBEHENIN
ALCOHOL
BUTYLATED HYDROXYTOLUENE
OCTYLDODECYL LACTATE
STEARIC ACID
MYRISTIC ACID
TOCOPHEROL
PHENOXYETHANOL
SORBIC ACID
METHYLPARABEN
ETHYLPARABEN
BUTYLPARABEN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
TALC

Packaging
#	Item Code	Package Description
1	NDC:64159-6975-1	30 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/01/2008

SENSAI FLUID FINISH FF206
titanium dioxide and octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64159-6976
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	4.5 g in 100 mL
OCTINOXATE (OCTINOXATE)	OCTINOXATE	3 g in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
CYCLOMETHICONE
MINERAL OIL
MALTITOL
GLYCERIN
DIPROPYLENE GLYCOL
PETROLATUM
SORBITAN ISOSTEARATE
DIISOSTEARYL MALATE
SQUALANE
TRIBEHENIN
ALCOHOL
BUTYLATED HYDROXYTOLUENE
OCTYLDODECYL LACTATE
STEARIC ACID
MYRISTIC ACID
TOCOPHEROL
PHENOXYETHANOL
SORBIC ACID
METHYLPARABEN
ETHYLPARABEN
BUTYLPARABEN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
TALC

Packaging
#	Item Code	Package Description
1	NDC:64159-6976-1	30 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/01/2008

Labeler - KANEBO COSMETICS INC (691041271)

Revised: 05/2012

Document Id: 339ac0e4-174c-486b-9a55-b7a05455f26f

Set id: ba134a01-38de-46e7-ab43-c8ae59391935

Version: 6

Effective Time: 20120518

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

SENSAI FLUID FINISH FF102

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