Drug Facts

Active ingredients	Purpose
OCTINOXATE 2.9%	Sunscreen
TITANIUM DIOXIDE 7.2%	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
reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- 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

MINERAL OIL, POLYMETHYL METHACRYLATE, DIMETHICONE, KAOLIN, TRIETHYLHEXANOIN, POLYETHYLENE, SORBITAN SESQUIISOSTEARATE, MICROCRYSTALLINE WAX, PEG/PPG-14/7 DIMETHYL ETHER, SAXIFRAGA SARMENTOSA EXTRACT, SODIUM HYALURONATE, SOPHORA ANGUSTIFOLIA ROOT EXTRACT, COPERNICIA CERIFERA (CARNAUBA) WAX, METHICONE, SILICA, WATER, ALUMINA, ALCOHOL, SODIUM MAGNESIUM SILICATE, HYDRATED SILICA, TRIETHOXYCAPRYLYLSILANE, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, BUTYLENE GLYCOL, GLYCERIN, TOCOPHEROL, HYDROGEN DIMETHICONE, DISTEARYLDIMONIUM CHLORIDE, BHT, SYZYGIUM JAMBOS LEAF EXTRACT, TIN OXIDE, 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 - 9 g Cartridge Carton - Fair Ivory

SHI SEIDO

Anti-Aging
Foundation

UV Protective
Stick Foundation

BROAD SPECTRUM
SPF 37

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

9g NET WT. .31 OZ.

Principal Display Panel - 9 g Cartridge Carton - Fair Ivory

PRINCIPAL DISPLAY PANEL - 9 g Cartridge Carton - Fair Ochre

SHI SEIDO

Anti-Aging
Foundation

UV Protective
Stick Foundation

BROAD SPECTRUM
SPF 37

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

9g NET WT. .31 OZ.

Principal Display Panel - 9 g Cartridge Carton - Fair Ochre

PRINCIPAL DISPLAY PANEL - 9 g Cartridge Carton - Beige

SHI SEIDO

Anti-Aging
Foundation

UV Protective
Stick Foundation

BROAD SPECTRUM
SPF 37

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

9g NET WT. .31 OZ.

Principal Display Panel - 9 g Cartridge Carton - Beige

PRINCIPAL DISPLAY PANEL - 9 g Cartridge Carton - Ochre

SHI SEIDO

Anti-Aging
Foundation

UV Protective
Stick Foundation

BROAD SPECTRUM
SPF 37

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

9g NET WT. .31 OZ.

Principal Display Panel - 9 g Cartridge Carton - Ochre

SHISEIDO UV PROTECTIVE FOUNDATION FAIR IVORY
octinoxate and titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-137
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	261 mg in 9 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	648 mg in 9 g

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
DIMETHICONE (UNII: 92RU3N3Y1O)
KAOLIN (UNII: 24H4NWX5CO)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
CARNAUBA WAX (UNII: R12CBM0EIZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
TOCOPHEROL (UNII: R0ZB2556P8)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-137-20	1 in 1 CARTON	02/01/2014
1		9 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2014

SHISEIDO UV PROTECTIVE FOUNDATION FAIR OCHRE
octinoxate and titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-138
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	261 mg in 9 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	648 mg in 9 g

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
DIMETHICONE (UNII: 92RU3N3Y1O)
KAOLIN (UNII: 24H4NWX5CO)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
CARNAUBA WAX (UNII: R12CBM0EIZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
TOCOPHEROL (UNII: R0ZB2556P8)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-138-20	1 in 1 CARTON	02/01/2014
1		9 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2014

SHISEIDO UV PROTECTIVE FOUNDATION BEIGE
octinoxate and titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-139
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	261 mg in 9 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	648 mg in 9 g

Ingredient Name	Strength
Inactive Ingredients
MINERAL OIL (UNII: T5L8T28FGP)
DIMETHICONE (UNII: 92RU3N3Y1O)
KAOLIN (UNII: 24H4NWX5CO)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
CARNAUBA WAX (UNII: R12CBM0EIZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
TOCOPHEROL (UNII: R0ZB2556P8)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-139-20	1 in 1 CARTON	02/01/2014
1		9 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2014

SHISEIDO UV PROTECTIVE FOUNDATION OCHRE
octinoxate and titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-140
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	261 mg in 9 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	648 mg in 9 g

Ingredient Name	Strength
Inactive Ingredients
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
MINERAL OIL (UNII: T5L8T28FGP)
DIMETHICONE (UNII: 92RU3N3Y1O)
KAOLIN (UNII: 24H4NWX5CO)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
CARNAUBA WAX (UNII: R12CBM0EIZ)
METHICONE (20 CST) (UNII: 6777U11MKT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
TOCOPHEROL (UNII: R0ZB2556P8)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-140-20	1 in 1 CARTON	02/01/2014
1		9 g in 1 CARTRIDGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2014

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Name	Address	ID/FEI	Business Operations
Establishment
SHISEIDO AMERICA INC.		782677132	manufacture(58411-137, 58411-138, 58411-139, 58411-140) , analysis(58411-137, 58411-138, 58411-139, 58411-140)