SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL BASE UV IVORY- octinoxate and titanium dioxide paste SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL BASE UV GREEN- octinoxate and titanium dioxide paste SHISEIDO WHITE LUCENT BRIGHTENING SPOT-CONTROL BASE UV PINK- octinoxate and titanium dioxide paste

SHISEIDO WHITE LUCENT by

Drug Labeling and Warnings

SHISEIDO WHITE LUCENT 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 2.9%	Sunscreen
TITANIUM DIOXIDE 8.4%	Sunscreen

Use

• helps prevent sunburn

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

CYCLOMETHICONE, WATER, SD ALCOHOL 40-B, BUTYLENE GLYCOL, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, PEG-10 DIMETHICONE, CETYL ETHYLHEXANOATE, TRANEXAMIC ACID, ALUMINUM HYDROXIDE, GLYCERIN, SORBITAN SESQUIISOSTEARATE, DISTEARDIMONIUM HECTORITE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PEG/PPG-14/7 DIMETHYL ETHER, 2-O-ETHYL ASCORBIC ACID, SODIUM HYALURONATE, STEARIC ACID, ISOSTEARIC ACID, ALUMINUM DISTEARATE, TRISODIUM EDTA, POLYSILICONE-2, SODIUM METABISULFITE, BHT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES, CHROMIUM HYDROXIDE GREEN,

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 - 30mL Tube Carton - IVORY

SHISEIDO

WHITE LUCENT

Brightening
Spot-Control
Base UV

BROAD SPECTRUM
SPF 37

SUNSCREEN

30mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 30mL Tube Carton - GREEN

SHISEIDO

WHITE LUCENT

Brightening
Spot-Control
Base UV

BROAD SPECTRUM
SPF 37

SUNSCREEN

30mL NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 30mL Tube Carton - PINK

SHISEIDO

WHITE LUCENT

Brightening
Spot-Control
Base UV

BROAD SPECTRUM
SPF 37

SUNSCREEN

30mL NET WT. 1.1 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO WHITE LUCENT   BRIGHTENING SPOT-CONTROL BASE UV IVORY
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-249
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.9396 g  in 32.4 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.7216 g  in 32.4 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ISOSTEARIC ACID (UNII: X33R8U0062)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE TRISODIUM (UNII: 420IP921MB)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-249-60	1 in 1 CARTON
1		32.4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2011

SHISEIDO WHITE LUCENT   BRIGHTENING SPOT-CONTROL BASE UV GREEN
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-250
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.9396 g  in 32.4 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.7216 g  in 32.4 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ISOSTEARIC ACID (UNII: X33R8U0062)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE TRISODIUM (UNII: 420IP921MB)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-250-60	1 in 1 CARTON
1		32.4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2011

SHISEIDO WHITE LUCENT   BRIGHTENING SPOT-CONTROL BASE UV PINK
octinoxate and titanium dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-251
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.9396 g  in 32.4 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.7216 g  in 32.4 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
TRANEXAMIC ACID (UNII: 6T84R30KC1)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ISOSTEARIC ACID (UNII: X33R8U0062)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE TRISODIUM (UNII: 420IP921MB)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-251-60	1 in 1 CARTON
1		32.4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2011

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(52686-249, 52686-250, 52686-251) , ANALYSIS(52686-249, 52686-250, 52686-251)

Establishment
Name	Address	ID/FEI	Business Operations
Davlyn Industries Inc		624436254	MANUFACTURE(52686-249, 52686-250, 52686-251)