SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B00- titanium dioxide powder SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) B100- titanium dioxide powder SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) I100- titanium dioxide powder SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) WB40- titanium dioxide powder SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) WB60- titanium dioxide powder

SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) by

Drug Labeling and Warnings

SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL) 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

TITANUIM DIOXIDE 4.5%

Purpose

Sunscreen

Use

• helps prevent sunburn

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

CYCLOMETHICONE, WATER, GLYCERIN, DIMETHICONE, DIPROPYLENE GLYCOL, PARAFFIN, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SORBITAN SESQUIISOSTEARATE, PETROLATUM, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, MICROCRYSTALLINE WAX, PEG/PPG-36/41 DIMETHYL ETHER, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, SODIUM HYALURONATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, POLYSILICONE-2, ALUMINA, HYDROGEN DIMETHICONE, DISTEARYLDIMONIUM CHLORIDE, PALMITIC ACID, PEG-10 DIMETHICONE, ALUMINUM HYDROXIDE, BARIUM SULFATE, TOCOPHEROL, ISOPROPYL ALCOHOL, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE, METHICONE, TITANIUM DIOXIDE, TETRADECENE, PHENOXYETHANOL, 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 - 12 g Tray Carton - B00

SHISEIDO

B00

Advanced Hydro-Liquid
Compact (Refill)
Flawless, Radiant
Coverage Foundation

BROAD SPECTRUM
SPF 15
sunscreen

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - B100

SHISEIDO

B100

Advanced Hydro-Liquid
Compact (Refill)
Flawless, Radiant
Coverage Foundation

BROAD SPECTRUM
SPF 15
sunscreen

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - I100

SHISEIDO

I100

Advanced Hydro-Liquid
Compact (Refill)
Flawless, Radiant
Coverage Foundation

BROAD SPECTRUM
SPF 15
sunscreen

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - WB40

SHISEIDO

WB40

Advanced Hydro-Liquid
Compact (Refill)
Flawless, Radiant
Coverage Foundation

BROAD SPECTRUM
SPF 15
sunscreen

12g NET WT. .42 OZ.

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - WB60

SHISEIDO

WB60

Advanced Hydro-Liquid
Compact (Refill)
Flawless, Radiant
Coverage Foundation

BROAD SPECTRUM
SPF 15
sunscreen

12g NET WT. .42 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL)   B00
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-174
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	540 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PARAFFIN (UNII: I9O0E3H2ZE)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PETROLATUM (UNII: 4T6H12BN9U)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ROSEMARY OIL (UNII: 8LGU7VM393)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ALUMINUM OXIDE (UNII: LMI26O6933)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PALMITIC ACID (UNII: 2V16EO95H1)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-174-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	06/01/2014

SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL)   B100
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-175
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	540 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PARAFFIN (UNII: I9O0E3H2ZE)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PETROLATUM (UNII: 4T6H12BN9U)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ROSEMARY OIL (UNII: 8LGU7VM393)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ALUMINUM OXIDE (UNII: LMI26O6933)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PALMITIC ACID (UNII: 2V16EO95H1)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-175-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	06/01/2014

SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL)   I100
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-176
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	540 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PARAFFIN (UNII: I9O0E3H2ZE)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PETROLATUM (UNII: 4T6H12BN9U)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ROSEMARY OIL (UNII: 8LGU7VM393)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ALUMINUM OXIDE (UNII: LMI26O6933)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PALMITIC ACID (UNII: 2V16EO95H1)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-176-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	06/01/2014

SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL)   WB40
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-177
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	540 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PARAFFIN (UNII: I9O0E3H2ZE)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PETROLATUM (UNII: 4T6H12BN9U)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ROSEMARY OIL (UNII: 8LGU7VM393)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ALUMINUM OXIDE (UNII: LMI26O6933)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PALMITIC ACID (UNII: 2V16EO95H1)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-177-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	06/01/2014

SHISEIDO ADVANCED HYDRO-LIQUID COMPACT (REFILL)   WB60
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-178
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	540 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PARAFFIN (UNII: I9O0E3H2ZE)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PETROLATUM (UNII: 4T6H12BN9U)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
ROSEMARY OIL (UNII: 8LGU7VM393)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ALUMINUM OXIDE (UNII: LMI26O6933)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
PALMITIC ACID (UNII: 2V16EO95H1)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BARIUM SULFATE (UNII: 25BB7EKE2E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-178-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	06/01/2014

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(58411-174, 58411-175, 58411-176, 58411-177, 58411-178) , ANALYSIS(58411-174, 58411-175, 58411-176, 58411-177, 58411-178)

Establishment
Name	Address	ID/FEI	Business Operations
Davlyn Industries Inc		624436254	MANUFACTURE(58411-174, 58411-175, 58411-176, 58411-177, 58411-178)