ADVANCED HYDRO-LIQUID COMPACT (REFILL) I00- titanium dioxide powder ADVANCED HYDRO-LIQUID COMPACT (REFILL) I20- titanium dioxi

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)
Available from:
SHISEIDO CO., LTD.
INN (International Name):
Titanium dioxide
Composition:
Titanium dioxide 1.7 g in 12 g
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen - helps prevent sunburn - higher SPF gives more sunburn protection
Authorization status:
OTC monograph not final
Authorization number:
52685-308-30, 52685-309-30, 52685-310-30, 52685-311-30, 52685-312-30, 52685-313-30, 52685-314-30, 52685-315-30, 52685-316-30, 52685-317-30, 52685-318-30

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.

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Shiseido Advanced Hydro-Liquid Compact Foundation

Drug Facts

Active ingredient

TITANIUM DIOAXIDE 14.2%

Purpos e

Sunscreen

Us es

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

s uns creen

12g NET WT. .42 OZ.

ADVANCED HYDRO-LIQUID COMPACT (REFILL) I00

titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-30 8

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium dio xide (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP)

Titanium dio xide

1.7 g in 12 g

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-30 8 -30

1 in 1 CARTON

1

12 g in 1 TRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 9 /0 1/20 0 9

ADVANCED HYDRO-LIQUID COMPACT (REFILL) I20

titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-30 9

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium dio xide (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP)

Titanium dio xide

1.7 g in 12 g

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-30 9 -30

1 in 1 CARTON

1

12 g in 1 TRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 9 /0 1/20 0 9

ADVANCED HYDRO-LIQUID COMPACT (REFILL) I40

titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-310

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium dio xide (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP)

Titanium dio xide

1.7 g in 12 g

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-310 -30

1 in 1 CARTON

1

12 g in 1 TRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 9 /0 1/20 0 9

ADVANCED HYDRO-LIQUID COMPACT (REFILL) I60

titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-311

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium dio xide (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP)

Titanium dio xide

1.7 g in 12 g

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-311-30

1 in 1 CARTON

1

12 g in 1 TRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 9 /0 1/20 0 9

ADVANCED HYDRO-LIQUID COMPACT (REFILL) B20

titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-312

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium dio xide (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP)

Titanium dio xide

1.7 g in 12 g

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-312-30

1 in 1 CARTON

1

12 g in 1 TRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 9 /0 1/20 0 9

ADVANCED HYDRO-LIQUID COMPACT (REFILL) B40

titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-313

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium dio xide (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP)

Titanium dio xide

1.7 g in 12 g

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-313-30

1 in 1 CARTON

1

12 g in 1 TRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 9 /0 1/20 0 9

ADVANCED HYDRO-LIQUID COMPACT (REFILL) B60

titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-314

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium dio xide (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP)

Titanium dio xide

1.7 g in 12 g

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-314-30

1 in 1 CARTON

1

12 g in 1 TRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 9 /0 1/20 0 9

ADVANCED HYDRO-LIQUID COMPACT (REFILL) O20

titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-315

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium dio xide (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP)

Titanium dio xide

1.7 g in 12 g

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-315-30

1 in 1 CARTON

1

12 g in 1 TRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 9 /0 1/20 0 9

ADVANCED HYDRO-LIQUID COMPACT (REFILL) O40

titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-316

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium dio xide (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP)

Titanium dio xide

1.7 g in 12 g

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-316 -30

1 in 1 CARTON

1

12 g in 1 TRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 9 /0 1/20 0 9

ADVANCED HYDRO-LIQUID COMPACT (REFILL) O60

titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-317

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium dio xide (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP)

Titanium dio xide

1.7 g in 12 g

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-317-30

1 in 1 CARTON

1

12 g in 1 TRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 9 /0 1/20 0 9

SHISEIDO CO., LTD.

ADVANCED HYDRO-LIQUID COMPACT (REFILL) O80

titanium dioxide powder

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:526 8 5-318

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Tita nium dio xide (UNII: 15FIX9 V2JP) (Titanium dio xide - UNII:15FIX9 V2JP)

Titanium dio xide

1.7 g in 12 g

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:526 8 5-318 -30

1 in 1 CARTON

1

12 g in 1 TRAY

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 9 /0 1/20 0 9

Labeler -

SHISEIDO CO., LT D. (690536453)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

SHISEIDO CO., LTD.

6 9 0 536 453

Ma nufa c ture

Revised: 12/2009

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