Drug Facts

Active ingredients	Purpose
OCTINOXATE 2.9%	Sunscreen
TITANIUM DIOXIDE 2.6%	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　

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

WATER•DIMETHICONE•GLYCERIN•SD ALCOHOL 40-B•METHYL METHACRYLATE CROSSPOLYMER•DIISOSTEARYL MALATE•BETAINE•PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•PEG-10 DIMETHICONE•SORBITAN SESQUIISOSTEARATE•POTASSIUM METHOXYSALICYLATE•TRIMETHYLSILOXYSILICATE•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•TOCOPHERYL ACETATE•2-O-ETHYL ASCORBIC ACID•SODIUM HYALURONATE•PAEONIA SUFFRUTICOSA ROOT EXTRACT•PEG/PPG-14/7 DIMETHYL ETHER•REHMANNIA CHINENSIS ROOT EXTRACT•UNCARIA GAMBIR EXTRACT•CHLORELLA VULGARIS EXTRACT•ALUMINUM HYDROXIDE•DISTEARDIMONIUM HECTORITE•ALUMINUM DISTEARATE•POLYSILICONE-2•DISODIUM EDTA•SILICA•BUTYLENE GLYCOL•ALANINE•SODIUM CITRATE•ALCOHOL•BHT･TOCOPHEROL•CITRIC ACID•BARIUM SULFATE•SODIUM METABISULFITE•PRUNUS YEDOENSIS LEAF EXTRACT•HYDROGEN DIMETHICONE•ALUMINA•METHYLPARABEN•ETHYLPARABEN･FRAGRANCE•TITANIUM DIOXIDE•IRON OXIDES•MICA•

Other information

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

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 4 mL Bottle Carton - Natural Light

SHISEIDO

WHITE LUCENT

OnMakeup
Spot Correcting
Serum

BROAD SPECTRUM
SPF 25

SUNSCREEN

PROAPPROACH×2

4mL NET WT. .16 OZ.

PRINCIPAL DISPLAY PANEL - 4 mL Bottle Carton - Natural

SHISEIDO

WHITE LUCENT

OnMakeup
Spot Correcting
Serum

BROAD SPECTRUM
SPF 25

SUNSCREEN

PROAPPROACH×2

4mL NET WT. .16 OZ.

PRINCIPAL DISPLAY PANEL - 4 mL Bottle Carton - Natural

PRINCIPAL DISPLAY PANEL - 4 mL Bottle Carton - Medium

SHISEIDO

WHITE LUCENT

OnMakeup
Spot Correcting
Serum

BROAD SPECTRUM
SPF 25

SUNSCREEN

PROAPPROACH×2

4mL NET WT. .16 OZ.

PRINCIPAL DISPLAY PANEL - 4 mL Bottle Carton - Medium

SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL LIGHT
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-296
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	138 mg in 4 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	123 mg in 4 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BETAINE (UNII: 3SCV180C9W)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA X SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALANINE (UNII: OF5P57N2ZX)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PRUNUS X YEDOENSIS LEAF (UNII: 1Z125GA907)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
ALUMINUM OXIDE (UNII: LMI26O6933)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-296-10	1 in 1 CARTON	02/01/2017
1		4 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M020	02/01/2017

SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-297
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	138 mg in 4 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	123 mg in 4 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BETAINE (UNII: 3SCV180C9W)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA X SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALANINE (UNII: OF5P57N2ZX)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PRUNUS X YEDOENSIS LEAF (UNII: 1Z125GA907)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
ALUMINUM OXIDE (UNII: LMI26O6933)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-297-10	1 in 1 CARTON	02/01/2017
1		4 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M020	02/01/2017

SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM MEDIUM
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-298
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	138 mg in 4 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	123 mg in 4 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
BETAINE (UNII: 3SCV180C9W)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAEONIA X SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALANINE (UNII: OF5P57N2ZX)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BARIUM SULFATE (UNII: 25BB7EKE2E)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PRUNUS X YEDOENSIS LEAF (UNII: 1Z125GA907)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
ALUMINUM OXIDE (UNII: LMI26O6933)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58411-298-10	1 in 1 CARTON	02/01/2017	05/01/2022
1		4 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M020	02/01/2017	05/01/2022

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Name	Address	ID/FEI	Business Operations
Establishment
SHISEIDO AMERICA INC.		782677132	manufacture(58411-296, 58411-297, 58411-298) , analysis(58411-296, 58411-297, 58411-298)