SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORY- octinoxate, octocrylene, and titanium dioxide powder SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT BEIGE- octinoxate, octocrylene, and titanium dioxide powder SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT IVORY- octinoxate, octocrylene, and titanium dioxide powder SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT OCHRE- octinoxate, octocrylene, and titanium dioxide powder SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM BEIGE- octinoxate, octocrylene, and titanium dioxide powder SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM IVORY- octinoxate, octocrylene, and titanium dioxide powder SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM OCHRE- octinoxate, octocrylene, and titanium dioxide powder SHISEIDO UV PROTECTIVE COMPACT (REFILL) DARK BEIGE- octinoxate, octocrylene, and titanium dioxide powder SHISEIDO UV PROTECTIVE COMPACT (REFILL) DARK IVORY- octinoxate, octocrylene, and titanium dioxide powder

SHISEIDO UV PROTECTIVE COMPACT (REFILL) by

Drug Labeling and Warnings

SHISEIDO UV PROTECTIVE COMPACT (REFILL) 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 7.4%	Sunscreen
OCTOCRYLENE 5.0%	Sunscreen
TITANIUM DIOXIDE 11.8%	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

SYNTHETIC FLUORPHLOGOPITE,DIMETHICONE,SILICA,NYLON-12,VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER,PETROLATUM,METHICONE,TRIETHYLHEXANOIN,PEG/PPG-14/7 DIMETHYL ETHER,TOCOPHERYL ACETATE,SAXIFRAGA SARMENTOSA EXTRACT,SODIUM HYALURONATE,SOPHORA ANGUSTIFOLIA ROOT EXTRACT,SORBITAN SESQUIISOSTEARATE,HYDROGEN DIMETHICONE,ALUMINUM HYDROXIDE,WATER,POLYSILICONE-2,ALCOHOL,SODIUM MAGNESIUM SILICATE,HYDRATED SILICA,TRIETHOXYCAPRYLYLSILANE,ALUMINUM DISTEARATE,BUTYLENE GLYCOL,GLYCERIN,TOCOPHEROL,BHT,DISTEARYLDIMONIUM CHLORIDE,SYZYGIUM JAMBOS LEAF EXTRACT,TIN OXIDE,CHLORPHENESIN,FRAGRANCE,MICA,TITANIUM DIOXIDE,IRON OXIDES,ZINC OXIDE,

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 - 12 g Tray Carton - Fair Ivory

SHI SEIDO

Anti-Aging Foundation

36

UV Protective
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Light Beige

SHI SEIDO

Anti-Aging Foundation

36

UV Protective
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Light Ivory

SHI SEIDO

Anti-Aging Foundation

36

UV Protective
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Light Ochre

SHI SEIDO

Anti-Aging Foundation

36

UV Protective
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Medium Beige

SHI SEIDO

Anti-Aging Foundation

36

UV Protective
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Medium Ivory

SHI SEIDO

Anti-Aging Foundation

36

UV Protective
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Medium Ochre

SHI SEIDO

Anti-Aging Foundation

36

UV Protective
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Dark Beige

SHI SEIDO

Anti-Aging Foundation

36

UV Protective
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Dark Ivory

SHI SEIDO

Anti-Aging Foundation

36

UV Protective
Compact Foundation
(Refill)

BROAD SPECTRUM
SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO UV PROTECTIVE COMPACT (REFILL)  FAIR IVORY
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	888 mg  in 12 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	600 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1416 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
PETROLATUM (UNII: 4T6H12BN9U)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-121-30	1 in 1 CARTON	02/01/2014
1		12 g in 1 TRAY; 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 COMPACT (REFILL)  LIGHT BEIGE
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	888 mg  in 12 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	600 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1416 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
PETROLATUM (UNII: 4T6H12BN9U)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-122-30	1 in 1 CARTON	02/01/2014
1		12 g in 1 TRAY; 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 COMPACT (REFILL)  LIGHT IVORY
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	888 mg  in 12 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	600 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1416 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
PETROLATUM (UNII: 4T6H12BN9U)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-123-30	1 in 1 CARTON	02/01/2014
1		12 g in 1 TRAY; 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 COMPACT (REFILL)  LIGHT OCHRE
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	888 mg  in 12 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	600 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1416 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
PETROLATUM (UNII: 4T6H12BN9U)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-124-30	1 in 1 CARTON	02/01/2014
1		12 g in 1 TRAY; 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 COMPACT (REFILL)  MEDIUM BEIGE
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	888 mg  in 12 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	600 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1416 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
PETROLATUM (UNII: 4T6H12BN9U)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-125-30	1 in 1 CARTON	02/01/2014
1		12 g in 1 TRAY; 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 COMPACT (REFILL)  MEDIUM IVORY
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	888 mg  in 12 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	600 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1416 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
PETROLATUM (UNII: 4T6H12BN9U)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-126-30	1 in 1 CARTON	02/01/2014
1		12 g in 1 TRAY; 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 COMPACT (REFILL)  MEDIUM OCHRE
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	888 mg  in 12 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	600 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1416 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
PETROLATUM (UNII: 4T6H12BN9U)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-127-30	1 in 1 CARTON	02/01/2014
1		12 g in 1 TRAY; 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 COMPACT (REFILL)  DARK BEIGE
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-128
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	888 mg  in 12 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	600 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1416 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
PETROLATUM (UNII: 4T6H12BN9U)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-128-30	1 in 1 CARTON	02/01/2014
1		12 g in 1 TRAY; 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 COMPACT (REFILL)  DARK IVORY
octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	888 mg  in 12 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	600 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1416 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
PETROLATUM (UNII: 4T6H12BN9U)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-129-30	1 in 1 CARTON	02/01/2014
1		12 g in 1 TRAY; 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(58411-121, 58411-122, 58411-123, 58411-124, 58411-125, 58411-126, 58411-127, 58411-128, 58411-129) , analysis(58411-121, 58411-122, 58411-123, 58411-124, 58411-125, 58411-126, 58411-127, 58411-128, 58411-129)