ADVANCED HYDRO-LIQUID COMPACT (REFILL) I00- titanium dioxide powder ADVANCED HYDRO-LIQUID COMPACT (REFILL) I20- titanium dioxide powder ADVANCED HYDRO-LIQUID COMPACT (REFILL) I40- titanium dioxide powder ADVANCED HYDRO-LIQUID COMPACT (REFILL) I60- titanium dioxide powder ADVANCED HYDRO-LIQUID COMPACT (REFILL) B20- titanium dioxide powder ADVANCED HYDRO-LIQUID COMPACT (REFILL) B40- titanium dioxide powder ADVANCED HYDRO-LIQUID COMPACT (REFILL) B60- titanium dioxide powder ADVANCED HYDRO-LIQUID COMPACT (REFILL) O20- titanium dioxide powder ADVANCED HYDRO-LIQUID COMPACT (REFILL) O40- titanium dioxide powder ADVANCED HYDRO-LIQUID COMPACT (REFILL) O60- titanium dioxide powder ADVANCED HYDRO-LIQUID COMPACT (REFILL) O80- titanium dioxide powder

ADVANCED HYDRO-LIQUID COMPACT (REFILL) by

Drug Labeling and Warnings

ADVANCED HYDRO-LIQUID COMPACT (REFILL) by is a Otc medication manufactured, distributed, or labeled by SHISEIDO CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

TITANIUM DIOAXIDE 14.2%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection

Warnings

For external use only.

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

• rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply evenly before sun exposure and as needed
• children under 6 months of age: 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, DIMETHICONE/METHICONE COPOLYMER, ALUMINA, DISTEARYLDIMONIUM CHLORIDE, PALMITIC ACID, PEG-10 DIMETHICONE, BARIUM SULFATE, TOCOPHEROL, ISOPROPYL ALCOHOL, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE, METHICONE, TETRADECENE, PHENOXYETHANOL, IRON OXIDES, MICA,

Questions ?

1-800-906-7503

PRINCIPAL DISPLAY PANEL - 12g Carton

SHISEIDO

I00

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

SPF 15
sunscreen

12g NET WT. .42 OZ.

INGREDIENTS AND APPEARANCE

ADVANCED HYDRO-LIQUID COMPACT (REFILL)  I00
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-308
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	1.7 g  in 12 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-308-30	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	09/01/2009

ADVANCED HYDRO-LIQUID COMPACT (REFILL)  I20
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-309
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	1.7 g  in 12 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-309-30	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	09/01/2009

ADVANCED HYDRO-LIQUID COMPACT (REFILL)  I40
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-310
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	1.7 g  in 12 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-310-30	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	09/01/2009

ADVANCED HYDRO-LIQUID COMPACT (REFILL)  I60
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-311
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	1.7 g  in 12 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-311-30	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	09/01/2009

ADVANCED HYDRO-LIQUID COMPACT (REFILL)  B20
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-312
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	1.7 g  in 12 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-312-30	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	09/01/2009

ADVANCED HYDRO-LIQUID COMPACT (REFILL)  B40
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-313
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	1.7 g  in 12 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-313-30	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	09/01/2009

ADVANCED HYDRO-LIQUID COMPACT (REFILL)  B60
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-314
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	1.7 g  in 12 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-314-30	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	09/01/2009

ADVANCED HYDRO-LIQUID COMPACT (REFILL)  O20
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-315
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	1.7 g  in 12 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-315-30	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	09/01/2009

ADVANCED HYDRO-LIQUID COMPACT (REFILL)  O40
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-316
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	1.7 g  in 12 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-316-30	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	09/01/2009

ADVANCED HYDRO-LIQUID COMPACT (REFILL)  O60
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-317
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	1.7 g  in 12 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-317-30	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	09/01/2009

ADVANCED HYDRO-LIQUID COMPACT (REFILL)  O80
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52685-318
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	1.7 g  in 12 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-318-30	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	09/01/2009

Labeler - SHISEIDO CO., LTD. (690536453)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO CO., LTD.		690536453	Manufacture