SHISEIDO UV LIP COLOR SPLASH NAIROBI ORANGE- avobenzone, octinoxate, octocrylene, and oxybenzone gel SHISEIDO UV LIP COLOR SPLASH MIAMI PINK- avobenzone, octinoxate, octocrylene, and oxybenzone gel SHISEIDO UV LIP COLOR SPLASH ULURU RED- avobenzone, octinoxate, octocrylene, and oxybenzone gel SHISEIDO UV LIP COLOR SPLASH TAHITI BLUE- avobenzone, octinoxate, octocrylene, and oxybenzone gel

SHISEIDO UV LIP COLOR SPLASH by

Drug Labeling and Warnings

SHISEIDO UV LIP COLOR SPLASH 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
AVOBENZONE 2.5%	Sunscreen
OCTINOXATE 4.9%	Sunscreen
OCTOCRYLENE 3.0%	Sunscreen
OXYBENZONE 2.0%	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

(All shades, except Tahiti Blue)

TRIETHYLHEXANOIN∙DIISOSTEARYL MALATE∙HYDROGENATED POLYISOBUTENE∙TRIISOSTEARIN∙PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE∙DEXTRIN PALMITATE∙SILICA DIMETHYL SILYLATE∙CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL∙DIPROPYLENE GLYCOL∙GLYCERYL DIISOSTEARATE∙TOCOPHEROL∙TRIMETHYLOLPROPANE TRIETHYLHEXANOATE∙SIMETHICONE∙BHT∙METHICONE∙TETRADECENE∙SUCROSE TETRAISOSTEARATE∙ALUMINUM HYDROXIDE∙POLYSILICONE-2∙SILICA∙IRON OXIDES∙TITANIUM DIOXIDE∙RED 6∙RED 7∙

Inactive Ingredients

(For shade Tahiti Blue)

TRIETHYLHEXANOIN∙DIISOSTEARYL MALATE∙HYDROGENATED POLYISOBUTENE∙TRIISOSTEARIN∙PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE∙DEXTRIN PALMITATE∙SILICA DIMETHYL SILYLATE∙CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL∙DIPROPYLENE GLYCOL∙TOCOPHEROL∙SIMETHICONE∙GLYCERYL DIISOSTEARATE∙BHT∙SUCROSE TETRAISOSTEARATE∙TRIMETHYLOLPROPANE TRIETHYLHEXANOATE∙ALUMINUM HYDROXIDE∙POLYSILICONE-2∙TITANIUM DIOXIDE∙BLUE 1∙

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 - 10 mL Tube Carton - Nairobi Orange

SHISEIDO
GINZA TOKYO

UV Lip Color Splash

30

BROAD SPECTRUM
SPF 30

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

Nairobi Orange

10mL NET WT. .31 OZ.

PRINCIPAL DISPLAY PANEL - 10 mL Tube Carton - Miami Pink

SHISEIDO
GINZA TOKYO

UV Lip Color Splash

30

BROAD SPECTRUM
SPF 30

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

Miami Pink

10mL NET WT. .31 OZ.

PRINCIPAL DISPLAY PANEL - 10 mL Tube Carton - Uluru Red

SHISEIDO
GINZA TOKYO

UV Lip Color Splash

30

BROAD SPECTRUM
SPF 30

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

Uluru Red

10mL NET WT. .31 OZ.

PRINCIPAL DISPLAY PANEL - 10 mL Tube Carton - Tahiti Blue

SHISEIDO
GINZA TOKYO

UV Lip Color Splash

30

BROAD SPECTRUM
SPF 30

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

Tahiti Blue

10mL NET WT. .31 OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO UV LIP COLOR SPLASH   NAIROBI ORANGE
avobenzone, octinoxate, octocrylene, and oxybenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-360
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	238 mg  in 10 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	466 mg  in 10 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	285 mg  in 10 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	190 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TRIISOSTEARIN (UNII: 71503RH8KG)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
SAFFLOWER OIL (UNII: 65UEH262IS)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TRIMETHYLOLPROPANE TRIETHYLHEXANOATE (UNII: B952ZGW1IL)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
SUCROSE TETRAISOSTEARATE (UNII: FST191693T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 6 (UNII: 481744AI4O)
D&C RED NO. 7 (UNII: ECW0LZ41X8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-360-60	1 in 1 CARTON	02/01/2018
1		10 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/01/2018

SHISEIDO UV LIP COLOR SPLASH   MIAMI PINK
avobenzone, octinoxate, octocrylene, and oxybenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-361
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	238 mg  in 10 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	466 mg  in 10 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	285 mg  in 10 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	190 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TRIISOSTEARIN (UNII: 71503RH8KG)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
SAFFLOWER OIL (UNII: 65UEH262IS)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TRIMETHYLOLPROPANE TRIETHYLHEXANOATE (UNII: B952ZGW1IL)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
SUCROSE TETRAISOSTEARATE (UNII: FST191693T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 6 (UNII: 481744AI4O)
D&C RED NO. 7 (UNII: ECW0LZ41X8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-361-60	1 in 1 CARTON	02/01/2018
1		10 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/01/2018

SHISEIDO UV LIP COLOR SPLASH   ULURU RED
avobenzone, octinoxate, octocrylene, and oxybenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-362
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	238 mg  in 10 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	466 mg  in 10 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	285 mg  in 10 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	190 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TRIISOSTEARIN (UNII: 71503RH8KG)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
SAFFLOWER OIL (UNII: 65UEH262IS)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TRIMETHYLOLPROPANE TRIETHYLHEXANOATE (UNII: B952ZGW1IL)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
METHICONE (20 CST) (UNII: 6777U11MKT)
TETRADECENE (UNII: FW23481S7S)
SUCROSE TETRAISOSTEARATE (UNII: FST191693T)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 6 (UNII: 481744AI4O)
D&C RED NO. 7 (UNII: ECW0LZ41X8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-362-60	1 in 1 CARTON	02/01/2018
1		10 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/01/2018

SHISEIDO UV LIP COLOR SPLASH   TAHITI BLUE
avobenzone, octinoxate, octocrylene, and oxybenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-363
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	238 mg  in 10 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	466 mg  in 10 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	285 mg  in 10 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	190 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
TRIISOSTEARIN (UNII: 71503RH8KG)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
SAFFLOWER OIL (UNII: 65UEH262IS)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
GLYCERYL DIISOSTEARATE (UNII: 68BAV42LRC)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SUCROSE TETRAISOSTEARATE (UNII: FST191693T)
TRIMETHYLOLPROPANE TRIETHYLHEXANOATE (UNII: B952ZGW1IL)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-363-60	1 in 1 CARTON	02/01/2018
1		10 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/01/2018

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(58411-360, 58411-361, 58411-362, 58411-363) , ANALYSIS(58411-360, 58411-361, 58411-362, 58411-363)