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

SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM by

Drug Labeling and Warnings

SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICA 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 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

WATERDIMETHICONEGLYCERINSD ALCOHOL 40-BMETHYL METHACRYLATE CROSSPOLYMERDIISOSTEARYL MALATEBETAINEPEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONEPEG-10 DIMETHICONESORBITAN SESQUIISOSTEARATEPOTASSIUM METHOXYSALICYLATETRIMETHYLSILOXYSILICATEDIMETHICONE/VINYL DIMETHICONE CROSSPOLYMERTOCOPHERYL ACETATE2-O-ETHYL ASCORBIC ACIDSODIUM HYALURONATEPAEONIA SUFFRUTICOSA ROOT EXTRACTPEG/PPG-14/7 DIMETHYL ETHERREHMANNIA CHINENSIS ROOT EXTRACTUNCARIA GAMBIR EXTRACTCHLORELLA VULGARIS EXTRACTALUMINUM HYDROXIDEDISTEARDIMONIUM HECTORITEALUMINUM DISTEARATEPOLYSILICONE-2DISODIUM EDTASILICABUTYLENE GLYCOLALANINESODIUM CITRATEALCOHOLBHT･TOCOPHEROLCITRIC ACIDBARIUM SULFATESODIUM METABISULFITEPRUNUS YEDOENSIS LEAF EXTRACTHYDROGEN DIMETHICONEALUMINAMETHYLPARABENETHYLPARABEN･FRAGRANCETITANIUM DIOXIDEIRON OXIDESMICA

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

SHI SEIDO

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

SHI SEIDO

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

SHI SEIDO

WHITE LUCENT

OnMakeup
Spot Correcting
Serum

BROAD SPECTRUM
SPF 25

SUNSCREEN

PROAPPROACH×2

4mL NET WT. .16 OZ.

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2017

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

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