SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E  GOLDEN 1- octinoxate cream 
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E  GOLDEN 2- octinoxate cream 
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E  GOLDEN 3- octinoxate cream 
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E  GOLDEN 4- octinoxate cream 
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E  NEUTRAL 1- octinoxate cream 
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E  NEUTRAL 2- octinoxate cream 
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E  NEUTRAL 3- octinoxate cream 
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E  NEUTRAL 4- octinoxate cream 
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E  ROSE 2- octinoxate cream 
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E  ROSE 3- octinoxate cream 
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E  ROSE 4- octinoxate cream 
SHISEIDO AMERICAS CORPORATION

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.

----------

SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION E

Drug Facts

Active ingredients

OCTINOXATE 5.9%

Purpose

Sunscreen

Uses

Warnings

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:

Inactive Ingredients

WATER∙DIMETHICONE∙GLYCERIN∙NYLON-12∙SD ALCOHOL 40-B∙DIETHYLHEXYL SUCCINATE∙PEG-150∙PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙PEG-10 DIMETHICONE∙CYCLOHEXASILOXANE∙SORBITAN SESQUIISOSTEARATE∙POTASSIUM METHOXYSALICYLATE∙TRIMETHYLSILOXYSILICATE∙PIPERIDINEPROPIONIC ACID∙TOCOPHERYL ACETATE∙DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER∙2-O-ETHYL ASCORBIC ACID∙POLYMETHYL METHACRYLATE∙PRUNUS SPECIOSA LEAF EXTRACT∙ANGELICA ACUTILOBA ROOT EXTRACT∙SODIUM ACETYLATED HYALURONATE∙ISODONIS JAPONICUS LEAF/STALK EXTRACT∙CAMELLIA SINENSIS LEAF EXTRACT∙DISTEARDIMONIUM HECTORITE∙ISODODECANE∙ALUMINUM HYDROXIDE∙DIMETHICONE/PEG-10/15 CROSSPOLYMER∙POLYSILICONE-2∙TRISODIUM EDTA∙BUTYLENE GLYCOL∙SODIUM CITRATE∙BHT∙BARIUM SULFATE∙TOCOPHEROL∙CITRIC ACID∙SODIUM METABISULFITE∙ALCOHOL∙POLYMETHYLSILSESQUIOXANE∙DIPROPYLENE GLYCOL∙ALUMINA∙PHENOXYETHANOL∙FRAGRANCE∙TITANIUM DIOXIDE∙IRON OXIDES∙MICA∙

Other information

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Golden 1

SHI SEIDO
GINZA TOKYO

FUTURE SOLUTION LX
Total Radiance Foundation

SkingenecellEnmei

BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1.2 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Golden 1

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Golden 2

SHI SEIDO
GINZA TOKYO

FUTURE SOLUTION LX
Total Radiance Foundation

SkingenecellEnmei

BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1.2 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Golden 2

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Golden 3

SHI SEIDO
GINZA TOKYO

FUTURE SOLUTION LX
Total Radiance Foundation

SkingenecellEnmei

BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1.2 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Golden 3

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Golden 4

SHI SEIDO
GINZA TOKYO

FUTURE SOLUTION LX
Total Radiance Foundation

SkingenecellEnmei

BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1.2 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Golden 4

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Neutral 1

SHI SEIDO
GINZA TOKYO

FUTURE SOLUTION LX
Total Radiance Foundation

SkingenecellEnmei

BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1.2 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Neutral 1

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Neutral 2

SHI SEIDO
GINZA TOKYO

FUTURE SOLUTION LX
Total Radiance Foundation

SkingenecellEnmei

BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1.2 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Neutral 2

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Neutral 3

SHI SEIDO
GINZA TOKYO

FUTURE SOLUTION LX
Total Radiance Foundation

SkingenecellEnmei

BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1.2 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Neutral 3

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Neutral 4

SHI SEIDO
GINZA TOKYO

FUTURE SOLUTION LX
Total Radiance Foundation

SkingenecellEnmei

BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1.2 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Neutral 4

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Rose 2

SHI SEIDO
GINZA TOKYO

FUTURE SOLUTION LX
Total Radiance Foundation

SkingenecellEnmei

BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1.2 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Rose 2

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Rose 3

SHI SEIDO
GINZA TOKYO

FUTURE SOLUTION LX
Total Radiance Foundation

SkingenecellEnmei

BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1.2 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Rose 3

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Rose 4

SHI SEIDO
GINZA TOKYO

FUTURE SOLUTION LX
Total Radiance Foundation

SkingenecellEnmei

BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1.2 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - Rose 4
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   GOLDEN 1
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-329
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2036 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
NYLON-12 (UNII: 446U8J075B)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ISODODECANE (UNII: A8289P68Y2)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
ALCOHOL (UNII: 3K9958V90M)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-329-501 in 1 CARTON08/01/2017
130 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2017
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   GOLDEN 2
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-330
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1832 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
NYLON-12 (UNII: 446U8J075B)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ISODODECANE (UNII: A8289P68Y2)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
ALCOHOL (UNII: 3K9958V90M)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-330-501 in 1 CARTON08/01/2017
130 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2017
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   GOLDEN 3
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-331
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1832 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
NYLON-12 (UNII: 446U8J075B)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ISODODECANE (UNII: A8289P68Y2)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
ALCOHOL (UNII: 3K9958V90M)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-331-501 in 1 CARTON08/01/2017
130 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2017
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   GOLDEN 4
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-332
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1832 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
NYLON-12 (UNII: 446U8J075B)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ISODODECANE (UNII: A8289P68Y2)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
ALCOHOL (UNII: 3K9958V90M)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-332-501 in 1 CARTON08/01/2017
130 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2017
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   NEUTRAL 1
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-333
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1832 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
NYLON-12 (UNII: 446U8J075B)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ISODODECANE (UNII: A8289P68Y2)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
ALCOHOL (UNII: 3K9958V90M)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-333-501 in 1 CARTON08/01/2017
130 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2017
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   NEUTRAL 2
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-334
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1832 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
NYLON-12 (UNII: 446U8J075B)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ISODODECANE (UNII: A8289P68Y2)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
ALCOHOL (UNII: 3K9958V90M)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-334-501 in 1 CARTON08/01/2017
130 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2017
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   NEUTRAL 3
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-335
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1832 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
NYLON-12 (UNII: 446U8J075B)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ISODODECANE (UNII: A8289P68Y2)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
ALCOHOL (UNII: 3K9958V90M)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-335-501 in 1 CARTON08/01/2017
130 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2017
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   NEUTRAL 4
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-336
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1832 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
NYLON-12 (UNII: 446U8J075B)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ISODODECANE (UNII: A8289P68Y2)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
ALCOHOL (UNII: 3K9958V90M)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-336-501 in 1 CARTON08/01/2017
130 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2017
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   ROSE 2
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-337
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1832 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
NYLON-12 (UNII: 446U8J075B)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ISODODECANE (UNII: A8289P68Y2)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
ALCOHOL (UNII: 3K9958V90M)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-337-501 in 1 CARTON08/01/2017
130 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2017
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   ROSE 3
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-338
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1832 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
NYLON-12 (UNII: 446U8J075B)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ISODODECANE (UNII: A8289P68Y2)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
ALCOHOL (UNII: 3K9958V90M)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-338-501 in 1 CARTON08/01/2017
130 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2017
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   ROSE 4
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-339
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1832 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
NYLON-12 (UNII: 446U8J075B)  
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)  
POLYETHYLENE GLYCOL 7000 (UNII: Q0JET65GEL)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
PRUNUS SPECIOSA LEAF (UNII: Q71D900FVU)  
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ISODODECANE (UNII: A8289P68Y2)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
ALCOHOL (UNII: 3K9958V90M)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-339-501 in 1 CARTON08/01/2017
130 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2017
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132manufacture(58411-329, 58411-330, 58411-331, 58411-332, 58411-333, 58411-334, 58411-335, 58411-336, 58411-337, 58411-338, 58411-339) , analysis(58411-329, 58411-330, 58411-331, 58411-332, 58411-333, 58411-334, 58411-335, 58411-336, 58411-337, 58411-338, 58411-339)

Revised: 12/2018
Document Id: 7cf28e2f-2a50-27bf-e053-2991aa0a27b2
Set id: 8a9294c2-3933-4f9c-b7e6-1f446f441a16
Version: 2
Effective Time: 20181213
 
SHISEIDO AMERICAS CORPORATION