SHISEIDO UV PROTECTIVE FOUNDATION FAIR IVORY- octinoxate and titanium dioxide stick SHISEIDO UV PROTECTIVE FOUNDATION FAIR OCHRE- octinoxate and titanium dioxide stick SHISEIDO UV PROTECTIVE FOUNDATION BEIGE- octinoxate and titanium dioxide stick SHISEIDO UV PROTECTIVE FOUNDATION OCHRE- octinoxate and titanium dioxide stick

SHISEIDO UV PROTECTIVE FOUNDATION by

Drug Labeling and Warnings

SHISEIDO UV PROTECTIVE FOUNDATION 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 INGREDIENT

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

37

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

SHI SEIDO

Anti-Aging
Foundation

37

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

SHI SEIDO

Anti-Aging
Foundation

37

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

SHI SEIDO

Anti-Aging
Foundation

37

UV Protective
Stick Foundation

BROAD SPECTRUM
SPF 37

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

9g NET WT. .31 OZ.

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2014

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

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