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
SHISEIDO CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Shiseido Advanced Hydro-Liquid Compact Foundation

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 ?

PRINCIPAL DISPLAY PANEL - 12g Carton

SHISEIDO

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

SPF 15
sunscreen

12g NET WT. .42 OZ.

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

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

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE (UNII: NMQ347994Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-308-30	1 in 1 CARTON	09/01/2009	12/31/2020
1		12 g in 1 TRAY; 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	09/01/2009	12/31/2020

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

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

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE (UNII: NMQ347994Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-309-30	1 in 1 CARTON	09/01/2009	12/31/2020
1		12 g in 1 TRAY; 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	09/01/2009	12/31/2020

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

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

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE (UNII: NMQ347994Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-310-30	1 in 1 CARTON	09/01/2009	12/31/2020
1		12 g in 1 TRAY; 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	09/01/2009	12/31/2020

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

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

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE (UNII: NMQ347994Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-311-30	1 in 1 CARTON	09/01/2009	12/31/2020
1		12 g in 1 TRAY; 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	09/01/2009	12/31/2020

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

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

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE (UNII: NMQ347994Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-312-30	1 in 1 CARTON	09/01/2009	12/31/2020
1		12 g in 1 TRAY; 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	09/01/2009	12/31/2020

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

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

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE (UNII: NMQ347994Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-313-30	1 in 1 CARTON	09/01/2009	12/31/2020
1		12 g in 1 TRAY; 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	09/01/2009	12/31/2020

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

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

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE (UNII: NMQ347994Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-314-30	1 in 1 CARTON	09/01/2009	12/31/2020
1		12 g in 1 TRAY; 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	09/01/2009	12/31/2020

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

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

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE (UNII: NMQ347994Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-315-30	1 in 1 CARTON	09/01/2009	12/31/2020
1		12 g in 1 TRAY; 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	09/01/2009	12/31/2020

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

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

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE (UNII: NMQ347994Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-316-30	1 in 1 CARTON	09/01/2009	12/31/2020
1		12 g in 1 TRAY; 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	09/01/2009	12/31/2020

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

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

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE (UNII: NMQ347994Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-317-30	1 in 1 CARTON	09/01/2009	12/31/2020
1		12 g in 1 TRAY; 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	09/01/2009	12/31/2020

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

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

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE (UNII: NMQ347994Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52685-318-30	1 in 1 CARTON	09/01/2009	12/31/2020
1		12 g in 1 TRAY; 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	09/01/2009	12/31/2020

Labeler - SHISEIDO CO., LTD. (690536453)

Name	Address	ID/FEI	Business Operations
Establishment
SHISEIDO CO., LTD.		690536453	MANUFACTURE(52685-308, 52685-309, 52685-310, 52685-311, 52685-312, 52685-313, 52685-314, 52685-315, 52685-316, 52685-317, 52685-318)

Revised: 9/2023

Document Id: 93ba1573-34d8-478c-8ffb-949c8fe4cdf4

Set id: f907bc6b-9df1-4686-8455-2436945cff36

Version: 2

Effective Time: 20230914

SHISEIDO CO., LTD.