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 FUTURE LX TOTAL RADIANCE FOUNDATION E by

Drug Labeling and Warnings

SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OCTINOXATE 5.9%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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:

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

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

• protect this product in this container from excessive heat and direct sun.

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 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 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 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 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 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 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 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 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 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 4

SHI SEIDO
GINZA TOKYO

FUTURE SOLUTION LX
Total Radiance Foundation

SkingenecellEnmei

BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1.2 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   GOLDEN 1
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-329
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2036 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-329-50	1 in 1 CARTON	08/01/2017
1		30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2017

SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   GOLDEN 2
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-330
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1832 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-330-50	1 in 1 CARTON	08/01/2017
1		30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2017

SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   GOLDEN 3
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-331
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1832 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-331-50	1 in 1 CARTON	08/01/2017
1		30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2017

SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   GOLDEN 4
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-332
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1832 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-332-50	1 in 1 CARTON	08/01/2017
1		30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2017

SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   NEUTRAL 1
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-333
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1832 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-333-50	1 in 1 CARTON	08/01/2017
1		30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2017

SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   NEUTRAL 2
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-334
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1832 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-334-50	1 in 1 CARTON	08/01/2017
1		30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2017

SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   NEUTRAL 3
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-335
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1832 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-335-50	1 in 1 CARTON	08/01/2017
1		30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2017

SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   NEUTRAL 4
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-336
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1832 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-336-50	1 in 1 CARTON	08/01/2017
1		30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2017

SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   ROSE 2
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-337
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1832 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-337-50	1 in 1 CARTON	08/01/2017
1		30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2017

SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   ROSE 3
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-338
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1832 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-338-50	1 in 1 CARTON	08/01/2017
1		30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2017

SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E   ROSE 4
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-339
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1832 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-339-50	1 in 1 CARTON	08/01/2017
1		30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2017

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(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)