SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION I00- octinoxate and titanium dioxide cream SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION I20- octinoxate and titanium dioxide cream SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION I40- octinoxate and titanium dioxide cream SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION I60- octinoxate and titanium dioxide cream SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION B20- octinoxate and titanium dioxide cream SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION B40- octinoxate and titanium dioxide cream SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION B60- octinoxate and titanium dioxide cream SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION O00- octinoxate and titanium dioxide cream SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION O20- octinoxate and titanium dioxide cream SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION O40- octinoxate and titanium dioxide cream SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION O60- octinoxate and titanium dioxide cream

SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
OCTINOXATE 2.9%	Sunscreen
TITANIUM DIOXIDE 2.9%	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-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙PEG-10 DIMETHICONE∙CYCLOMETHICONE∙SORBITAN SESQUIISOSTEARATE∙POTASSIUM METHOXYSALICYLATE∙TRIMETHYLSILOXYSILICATE∙PIPERIDINEPROPIONIC ACID∙TOCOPHERYL ACETATE∙DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER∙SODIUM ACETYLATED HYALURONATE∙CAMELLIA SINENSIS LEAF EXTRACT∙ALUMINUM HYDROXIDE∙DISTEARDIMONIUM HECTORITE∙ISODODECANE∙STEARIC ACID∙DIMETHICONE/PEG-10/15 CROSSPOLYMER∙POLYSILICONE-2∙TRISODIUM EDTA∙SILICA∙BHT∙BARIUM SULFATE∙TOCOPHEROL∙ALCOHOL∙POLYMETHYLSILSESQUIOXANE∙DIPROPYLENE GLYCOL∙SODIUM METABISULFITE∙HYDROGEN DIMETHICONE∙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 - I 00

SHISEIDO

I 00

FUTURE SOLUTION LX

Total Radiance Foundation
BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - I 20

SHISEIDO

I 20

FUTURE SOLUTION LX

Total Radiance Foundation
BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - I 40

SHISEIDO

I 40

FUTURE SOLUTION LX

Total Radiance Foundation
BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - I 60

SHISEIDO

I 60

FUTURE SOLUTION LX

Total Radiance Foundation
BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - B 20

SHISEIDO

B 20

FUTURE SOLUTION LX

Total Radiance Foundation
BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - B 40

SHISEIDO

B 40

FUTURE SOLUTION LX

Total Radiance Foundation
BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - B 60

SHISEIDO

B 60

FUTURE SOLUTION LX

Total Radiance Foundation
BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - O 00

SHISEIDO

O 00

FUTURE SOLUTION LX

Total Radiance Foundation
BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - O 20

SHISEIDO

O 20

FUTURE SOLUTION LX

Total Radiance Foundation
BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - O 40

SHISEIDO

O 40

FUTURE SOLUTION LX

Total Radiance Foundation
BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Jar Carton - O 60

SHISEIDO

O 60

FUTURE SOLUTION LX

Total Radiance Foundation
BROAD SPECTRUM SPF 20
SUNSCREEN

30mL NET WT. 1 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION   I00
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-225
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1023 mg  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1023 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)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALCOHOL (UNII: 3K9958V90M)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ALUMINUM OXIDE (UNII: LMI26O6933)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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: 58411-225-30	1 in 1 CARTON	10/01/2014
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 NOT FINAL	part352	10/01/2014

SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION   I20
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-226
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1023 mg  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1023 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)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALCOHOL (UNII: 3K9958V90M)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ALUMINUM OXIDE (UNII: LMI26O6933)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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: 58411-226-30	1 in 1 CARTON	10/01/2014
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 NOT FINAL	part352	10/01/2014

SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION   I40
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-227
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1023 mg  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1023 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)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALCOHOL (UNII: 3K9958V90M)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ALUMINUM OXIDE (UNII: LMI26O6933)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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: 58411-227-30	1 in 1 CARTON	10/01/2014
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 NOT FINAL	part352	10/01/2014

SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION   I60
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-228
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1023 mg  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1023 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)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALCOHOL (UNII: 3K9958V90M)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ALUMINUM OXIDE (UNII: LMI26O6933)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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: 58411-228-30	1 in 1 CARTON	10/01/2014
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 NOT FINAL	part352	10/01/2014

SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION   B20
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-229
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1023 mg  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1023 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)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALCOHOL (UNII: 3K9958V90M)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ALUMINUM OXIDE (UNII: LMI26O6933)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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: 58411-229-30	1 in 1 CARTON	10/01/2014
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 NOT FINAL	part352	10/01/2014

SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION   B40
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-230
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1023 mg  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1023 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)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALCOHOL (UNII: 3K9958V90M)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ALUMINUM OXIDE (UNII: LMI26O6933)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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: 58411-230-30	1 in 1 CARTON	10/01/2014
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 NOT FINAL	part352	10/01/2014

SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION   B60
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-231
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1023 mg  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1023 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)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALCOHOL (UNII: 3K9958V90M)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ALUMINUM OXIDE (UNII: LMI26O6933)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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: 58411-231-30	1 in 1 CARTON	10/01/2014
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 NOT FINAL	part352	10/01/2014

SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION   O00
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-232
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1023 mg  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1023 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)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALCOHOL (UNII: 3K9958V90M)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ALUMINUM OXIDE (UNII: LMI26O6933)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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: 58411-232-30	1 in 1 CARTON	10/01/2014
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 NOT FINAL	part352	10/01/2014

SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION   O20
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-233
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1023 mg  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1023 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)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALCOHOL (UNII: 3K9958V90M)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ALUMINUM OXIDE (UNII: LMI26O6933)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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: 58411-233-30	1 in 1 CARTON	10/01/2014
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 NOT FINAL	part352	10/01/2014

SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION   O40
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-234
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1023 mg  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1023 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)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALCOHOL (UNII: 3K9958V90M)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ALUMINUM OXIDE (UNII: LMI26O6933)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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: 58411-234-30	1 in 1 CARTON	10/01/2014
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 NOT FINAL	part352	10/01/2014

SHISEIDO FUTURE SOLUTION LX TOTAL RADIANCE FOUNDATION   O60
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-235
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1023 mg  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1023 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)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PIPERIDINEPROPIONIC ACID (UNII: 6L69A7VPHO)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE TRISODIUM (UNII: 420IP921MB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALCOHOL (UNII: 3K9958V90M)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ALUMINUM OXIDE (UNII: LMI26O6933)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
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: 58411-235-30	1 in 1 CARTON	10/01/2014
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 NOT FINAL	part352	10/01/2014

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(58411-225, 58411-226, 58411-227, 58411-228, 58411-229, 58411-230, 58411-231, 58411-232, 58411-233, 58411-234, 58411-235) , ANALYSIS(58411-225, 58411-226, 58411-227, 58411-228, 58411-229, 58411-230, 58411-231, 58411-232, 58411-233, 58411-234, 58411-235)