SHISEIDO RADIANT LIFTING FOUNDATION D10- octinoxate and titanium dioxide cream SHISEIDO RADIANT LIFTING FOUNDATION D20- octinoxate and titanium dioxide cream SHISEIDO RADIANT LIFTING FOUNDATION D30- octinoxate and titanium dioxide cream

SHISEIDO RADIANT LIFTING FOUNDATION by

Drug Labeling and Warnings

SHISEIDO RADIANT LIFTING FOUNDATION by is a Otc medication manufactured, distributed, or labeled by 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 3.4%	Sunscreen
TITANIUM DIOXIDE 5.8%	Sunscreen

INDICATIONS & USAGE

• 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, GLYCERIN, DIMETHICONE, BUTYLENE GLYCOL, NYLON-12, DIETHYLHEXYL SUCCINATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PEG-10 DIMETHICONE, DIPHENYLSILOXY PHENYL TRIMETHICONE, BIS-BUTYLDIMETHICONE POLYGLYCERYL-3, POLYMETHYL METHACRYLATE, TOCOPHERYL ACETATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, HYDROXYPROLINE, PEG/PPG-36/41 DIMETHYL ETHER, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, CYCLOMETHICONE, DISTEARDIMONIUM HECTORITE, TRISODIUM EDTA, POLYSILICONE-2, TOCOPHEROL, ALUMINA, TRIETHOXYCAPRYLYLSILANE, SODIUM METABISULFITE, HYDRATED SILICA, BARIUM SULFATE, BHT, METHICONE, SYZYGIUM JAMBOS LEAF EXTRACT, TETRADECENE, HYDROGEN DIMETHICONE, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE, TIN OXIDE, PHENOXYETHANOL, SODIUM DEHYDROACETATE, IRON OXIDES, TITANIUM DIOXIDE, 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 - 30mL Bottle Carton - D10

SHISEIDO

D10

Radiant Lifting
Foundation

Firming and Anti-wrinkle

BROAD SPECTRUM
SPF 17
sunscreen

30mL NET WT. 1.2 OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - D20

SHISEIDO

D20

Radiant Lifting
Foundation

Firming and Anti-wrinkle

BROAD SPECTRUM
SPF 17
sunscreen

30mL NET WT. 1.2 OZ.

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton - D30

SHISEIDO

D30

Radiant Lifting
Foundation

Firming and Anti-wrinkle

BROAD SPECTRUM
SPF 17
sunscreen

30mL NET WT. 1.2 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO RADIANT LIFTING FOUNDATION   D10
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-326
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1220 mg  in 35.88 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2081 mg  in 35.88 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NYLON-12 (UNII: 446U8J075B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
EDETATE TRISODIUM (UNII: 420IP921MB)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
MICA (UNII: V8A1AW0880)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LAVENDER OIL (UNII: ZBP1YXW0H8)
BARIUM SULFATE (UNII: 25BB7EKE2E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYDROXYPROLINE (UNII: RMB44WO89X)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-326-10	1 in 1 CARTON
1		35.88 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/01/2012

SHISEIDO RADIANT LIFTING FOUNDATION   D20
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-327
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1220 mg  in 35.88 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2081 mg  in 35.88 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NYLON-12 (UNII: 446U8J075B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
EDETATE TRISODIUM (UNII: 420IP921MB)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
MICA (UNII: V8A1AW0880)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LAVENDER OIL (UNII: ZBP1YXW0H8)
BARIUM SULFATE (UNII: 25BB7EKE2E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYDROXYPROLINE (UNII: RMB44WO89X)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-327-10	1 in 1 CARTON
1		35.88 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/01/2012

SHISEIDO RADIANT LIFTING FOUNDATION   D30
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-328
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1220 mg  in 35.88 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2081 mg  in 35.88 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NYLON-12 (UNII: 446U8J075B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE (UNII: NMQ347994Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM OXIDE (UNII: LMI26O6933)
EDETATE TRISODIUM (UNII: 420IP921MB)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
MICA (UNII: V8A1AW0880)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LAVENDER OIL (UNII: ZBP1YXW0H8)
BARIUM SULFATE (UNII: 25BB7EKE2E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYDROXYPROLINE (UNII: RMB44WO89X)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-328-10	1 in 1 CARTON
1		35.88 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/01/2012

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(52686-326, 52686-327, 52686-328) , ANALYSIS(52686-326, 52686-327, 52686-328)

Establishment
Name	Address	ID/FEI	Business Operations
Davlyn Industries Inc		624436254	MANUFACTURE(52686-326, 52686-327, 52686-328)