SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 1 LIGHT- octinoxate and titanium dioxide cream
SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 2 MEDIUM- octinoxate and titanium dioxide cream
SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 3 MEDIUM DEEP- octinoxate and titanium dioxide cream
SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 4 DEEP- octinoxate and titanium dioxide cream
SHISEIDO AMERICA INC.

----------

SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION

Drug Facts

Active ingredients	Purpose
OCTINOXATE 1.9%	Sunscreen
TITANIUM DIOXIDE 12.5%	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

WATER, CYCLOMETHICONE, GLYCERIN, DIMETHICONE, TALC, BUTYLENE GLYCOL, DIPROPYLENE GLYCOL, XYLITOL, PEG-10 DIMETHICONE, POLYMETHYL METHACRYLATE, TRIMETHYLSILOXYSILICATE, ALUMINUM HYDROXIDE, ALUMINUM DISTEARATE, DISTEARDIMONIUM HECTORITE, ERYTHRITOL, TREHALOSE, PEG/PPG-14/7 DIMETHYL ETHER, THIOTAURINE, HYDROXYPROPYL CYCLODEXTRIN, MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT, SODIUM HYALURONATE, CITRUS JUNOS SEED EXTRACT, PHYTOSTERYL MACADAMIATE, ISOSTEARIC ACID, CALCIUM STEARATE, GLYCERYL DIISOSTEARATE, ALCOHOL, TRISODIUM EDTA, POLYSILICONE-2, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, BHT, TOCOPHEROL, PEG-60 GLYCERYL ISOSTEARATE, PHENOXYETHANOL, FRAGRANCE, 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

SHISEIDO DIST. NEW YORK • PARIS • MILANO

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1 LIGHT

SHISEIDO

The Skincare

Tinted
Moisture Protection
BROAD SPECTRUM
SPF 21
SUNSCREEN

50mL NET WT. 2.1 OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 1 LIGHT

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2 MEDIUM

SHISEIDO

The Skincare

Tinted
Moisture Protection
BROAD SPECTRUM
SPF 21
SUNSCREEN

50mL NET WT. 2.1 OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 2 MEDIUM

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3 MEDIUM DEEP

SHISEIDO

The Skincare

Tinted
Moisture Protection
BROAD SPECTRUM
SPF 21
SUNSCREEN

50mL NET WT. 2.1 OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 3 MEDIUM DEEP

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 4 DEEP

SHISEIDO

The Skincare

Tinted
Moisture Protection
BROAD SPECTRUM
SPF 21
SUNSCREEN

50mL NET WT. 2.1 OZ.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - 4 DEEP

SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 1 LIGHT
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52686-260
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	1149 mg in 60.45 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	7556 mg in 60.45 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
TALC (UNII: 7SEV7J4R1U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
XYLITOL (UNII: VCQ006KQ1E)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ERYTHRITOL (UNII: RA96B954X6)
TREHALOSE (UNII: B8WCK70T7I)
THIOTAURINE (UNII: NQZ2D7AO62)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CITRUS JUNOS SEED (UNII: UY43O1Q45N)
ISOSTEARIC ACID (UNII: X33R8U0062)
CALCIUM STEARATE (UNII: 776XM7047L)
ALCOHOL (UNII: 3K9958V90M)
EDETATE TRISODIUM (UNII: 420IP921MB)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52686-260-60	1 in 1 CARTON	02/01/2008	04/30/2017
1		60.45 g in 1 TUBE; 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	02/01/2008	04/30/2017

SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 2 MEDIUM
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52686-261
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	1149 mg in 60.45 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	7556 mg in 60.45 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
TALC (UNII: 7SEV7J4R1U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
XYLITOL (UNII: VCQ006KQ1E)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ERYTHRITOL (UNII: RA96B954X6)
TREHALOSE (UNII: B8WCK70T7I)
THIOTAURINE (UNII: NQZ2D7AO62)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CITRUS JUNOS SEED (UNII: UY43O1Q45N)
ISOSTEARIC ACID (UNII: X33R8U0062)
CALCIUM STEARATE (UNII: 776XM7047L)
ALCOHOL (UNII: 3K9958V90M)
EDETATE TRISODIUM (UNII: 420IP921MB)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52686-261-60	1 in 1 CARTON	02/01/2008	04/30/2017
1		60.45 g in 1 TUBE; 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	02/01/2008	04/30/2017

SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 3 MEDIUM DEEP
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52686-262
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	1149 mg in 60.45 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	7556 mg in 60.45 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
TALC (UNII: 7SEV7J4R1U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
XYLITOL (UNII: VCQ006KQ1E)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ERYTHRITOL (UNII: RA96B954X6)
TREHALOSE (UNII: B8WCK70T7I)
THIOTAURINE (UNII: NQZ2D7AO62)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CITRUS JUNOS SEED (UNII: UY43O1Q45N)
ISOSTEARIC ACID (UNII: X33R8U0062)
CALCIUM STEARATE (UNII: 776XM7047L)
ALCOHOL (UNII: 3K9958V90M)
EDETATE TRISODIUM (UNII: 420IP921MB)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52686-262-60	1 in 1 CARTON	02/01/2008	04/30/2017
1		60.45 g in 1 TUBE; 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	02/01/2008	04/30/2017

SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 4 DEEP
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52686-263
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	1149 mg in 60.45 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	7556 mg in 60.45 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
TALC (UNII: 7SEV7J4R1U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
XYLITOL (UNII: VCQ006KQ1E)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TRIMETHYLSILOXYSILICATE (M/Q 0.66) (UNII: 5041RX63GN)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ERYTHRITOL (UNII: RA96B954X6)
TREHALOSE (UNII: B8WCK70T7I)
THIOTAURINE (UNII: NQZ2D7AO62)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CITRUS JUNOS SEED (UNII: UY43O1Q45N)
ISOSTEARIC ACID (UNII: X33R8U0062)
CALCIUM STEARATE (UNII: 776XM7047L)
ALCOHOL (UNII: 3K9958V90M)
EDETATE TRISODIUM (UNII: 420IP921MB)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52686-263-60	1 in 1 CARTON	02/01/2008	04/30/2017
1		60.45 g in 1 TUBE; 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	02/01/2008	04/30/2017

Labeler - SHISEIDO AMERICA INC. (782677132)

Name	Address	ID/FEI	Business Operations
Establishment
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(52686-260, 52686-261, 52686-262, 52686-263) , ANALYSIS(52686-260, 52686-261, 52686-262, 52686-263)

Name	Address	ID/FEI	Business Operations
Establishment
Davlyn Industries Inc		624436254	MANUFACTURE(52686-260, 52686-261, 52686-262, 52686-263)

Revised: 10/2023

Document Id: 032c2e33-d845-4eda-8339-48eef1af7255

Set id: 7ec01ada-207b-486d-91d5-f6e2c7433ac3

Version: 2

Effective Time: 20231018

SHISEIDO AMERICA INC.