SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) O00- octinoxate and titanium dioxide paste SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) O20- octinoxate and titanium dioxide paste SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) O40- octinoxate and titanium dioxide paste SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) O60- octinoxate and titanium dioxide paste SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) BF20- octinoxate and titanium dioxide paste SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) I00- octinoxate and titanium dioxide paste

SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) by

Drug Labeling and Warnings

SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL) by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICA INC., Davlyn Industries Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:	Purpose
OCTINOXATE 3.9%	Sunscreen
TITANIUM DIOXIDE 6.6%	Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

SYNTHETIC FLUORPHLOGOPITE, TALC, TRIETHYLHEXANOIN, DIMETHICONE, SILICA, SYNTHETIC WAX, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, TRANEXAMIC ACID, ALUMINUM HYDROXIDE, SORBITAN SESQUIISOSTEARATE, POLYMETHYL METHACRYLATE, SODIUM HYALURONATE, ALUMINUM DISTEARATE, POLYSILICONE-2, SODIUM MAGNESIUM SILICATE, GLYCERIN, TOCOPHEROL, BHT, CHLORPHENESIN, FRAGRANCE, MICA, TITANIUM DIOXIDE, IRON OXIDES,

Other information

• protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

SPL UNCLASSIFIED SECTION

SHISEIDO AMERICA INC. NEW YORK, N.Y. 10022
SHISEIDO DIST. NEW YORK PARIS MILANO

PRINCIPAL DISPLAY PANEL - 10g Tray Carton - O00

SHISEIDO

WHITE LUCENT

Brightening
Spot-Control Foundation
(Refill)

BROAD SPECTRUM
SPF 26

SUNSCREEN

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10g Tray Carton - O20

SHISEIDO

WHITE LUCENT

Brightening
Spot-Control Foundation
(Refill)

BROAD SPECTRUM
SPF 26

SUNSCREEN

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10g Tray Carton - O40

SHISEIDO

WHITE LUCENT

Brightening
Spot-Control Foundation
(Refill)

BROAD SPECTRUM
SPF 26

SUNSCREEN

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10g Tray Carton - O60

SHISEIDO

WHITE LUCENT

Brightening
Spot-Control Foundation
(Refill)

BROAD SPECTRUM
SPF 26

SUNSCREEN

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10g Tray Carton - BF20

SHISEIDO

WHITE LUCENT

Brightening
Spot-Control Foundation
(Refill)

BROAD SPECTRUM
SPF 26

SUNSCREEN

10g NET WT. .35 OZ.

PRINCIPAL DISPLAY PANEL - 10g Tray Carton - I00

SHISEIDO

WHITE LUCENT

Brightening
Spot-Control Foundation
(Refill)

BROAD SPECTRUM
SPF 26

SUNSCREEN

10g NET WT. .35 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL)   O00
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-252
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.39 g  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.66 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-252-30	1 in 1 CARTON
1		10 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	03/01/2011

SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL)   O20
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-253
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.39 g  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.66 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-253-30	1 in 1 CARTON
1		10 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	03/01/2011

SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL)   O40
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-254
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.39 g  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.66 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-254-30	1 in 1 CARTON
1		10 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	03/01/2011

SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL)   O60
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-255
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.39 g  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.66 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-255-30	1 in 1 CARTON
1		10 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	03/01/2011

SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL)   BF20
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-256
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.39 g  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.66 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-256-30	1 in 1 CARTON
1		10 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	03/01/2011

SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL FOUNDATION (REFILL)   I00
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-257
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.39 g  in 10 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.66 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-257-30	1 in 1 CARTON
1		10 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	03/01/2011

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(52686-252, 52686-253, 52686-254, 52686-255, 52686-256, 52686-257) , ANALYSIS(52686-252, 52686-253, 52686-254, 52686-255, 52686-256, 52686-257)

Establishment
Name	Address	ID/FEI	Business Operations
Davlyn Industries Inc		624436254	MANUFACTURE(52686-252, 52686-253, 52686-254, 52686-255, 52686-256, 52686-257)