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 THE SKINCARE TINTED MOISTURE PROTECTION by

Drug Labeling and Warnings

SHISEIDO THE SKINCARE TINTED MOISTURE PROTECTION 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 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

SPL UNCLASSIFIED SECTION

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 - 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 - 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 - 4 DEEP

SHISEIDO

The Skincare

Tinted
Moisture Protection
BROAD SPECTRUM
SPF 21
SUNSCREEN

50mL NET WT. 2.1 OZ.

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-260-60	1 in 1 CARTON
1		60.45 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2008

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-261-60	1 in 1 CARTON
1		60.45 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2008

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-262-60	1 in 1 CARTON
1		60.45 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2008

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-263-60	1 in 1 CARTON
1		60.45 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2008

Labeler - SHISEIDO AMERICA INC. (782677132)

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

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