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Package Insert and Label Information: ADVANCED HYDRO-LIQUID COMPACT (REFILL) I00

By SHISEIDO CO., LTD. | Last revised: 31 December 2009

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.

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

S HIS EIDO

I00

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

SPF 15 sunscreen

12g NET WT. .42 OZ.

Principal Display Panel
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium dioxide (Titanium dioxide) Titanium dioxide 1.7 g in 12 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52685-308-30 1 TRAY (TRAY) in 1 CARTON contains a TRAY
1 12 g in 1 TRAY This package is contained within the CARTON (52685-308-30)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium dioxide (Titanium dioxide) Titanium dioxide 1.7 g in 12 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52685-309-30 1 TRAY (TRAY) in 1 CARTON contains a TRAY
1 12 g in 1 TRAY This package is contained within the CARTON (52685-309-30)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium dioxide (Titanium dioxide) Titanium dioxide 1.7 g in 12 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52685-310-30 1 TRAY (TRAY) in 1 CARTON contains a TRAY
1 12 g in 1 TRAY This package is contained within the CARTON (52685-310-30)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium dioxide (Titanium dioxide) Titanium dioxide 1.7 g in 12 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52685-311-30 1 TRAY (TRAY) in 1 CARTON contains a TRAY
1 12 g in 1 TRAY This package is contained within the CARTON (52685-311-30)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium dioxide (Titanium dioxide) Titanium dioxide 1.7 g in 12 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52685-312-30 1 TRAY (TRAY) in 1 CARTON contains a TRAY
1 12 g in 1 TRAY This package is contained within the CARTON (52685-312-30)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium dioxide (Titanium dioxide) Titanium dioxide 1.7 g in 12 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52685-313-30 1 TRAY (TRAY) in 1 CARTON contains a TRAY
1 12 g in 1 TRAY This package is contained within the CARTON (52685-313-30)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium dioxide (Titanium dioxide) Titanium dioxide 1.7 g in 12 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52685-314-30 1 TRAY (TRAY) in 1 CARTON contains a TRAY
1 12 g in 1 TRAY This package is contained within the CARTON (52685-314-30)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium dioxide (Titanium dioxide) Titanium dioxide 1.7 g in 12 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52685-315-30 1 TRAY (TRAY) in 1 CARTON contains a TRAY
1 12 g in 1 TRAY This package is contained within the CARTON (52685-315-30)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium dioxide (Titanium dioxide) Titanium dioxide 1.7 g in 12 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52685-316-30 1 TRAY (TRAY) in 1 CARTON contains a TRAY
1 12 g in 1 TRAY This package is contained within the CARTON (52685-316-30)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium dioxide (Titanium dioxide) Titanium dioxide 1.7 g in 12 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52685-317-30 1 TRAY (TRAY) in 1 CARTON contains a TRAY
1 12 g in 1 TRAY This package is contained within the CARTON (52685-317-30)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium dioxide (Titanium dioxide) Titanium dioxide 1.7 g in 12 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52685-318-30 1 TRAY (TRAY) in 1 CARTON contains a TRAY
1 12 g in 1 TRAY This package is contained within the CARTON (52685-318-30)
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 Operations
SHISEIDO CO., LTD. 690536453 Manufacture

Revised: 12/2009 SHISEIDO CO., LTD.

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