Drug Facts

ACTIVE INGREDIENTS

ETHYLHEXYL METHOXYCINNAMATE 7%
TITANIUM DIOXIDE 4.15%
ZINC OXIDE 9.8%

PURPOSE

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.
Reapply at least every 2 hours.
Use a water-resistant sunscreen if swimming or sweating.
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 value 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-sleeved shirts, pants, hats, and sunglasses.
Children under 6 months of age: Ask a doctor.

INACTIVE INGREDIENTS

PHYLLOSTACHIS BAMBUSOIDES JUICE, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, PEG-10 DIMETHICONE, PHENYL TRIMETHICONE, BUTYLENE GLYCOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, ALCOHOL, ARBUTIN, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, POLYHYDROXYSTEARIC ACID, SODIUM CHLORIDE, POLYMETHYL METHACRYLATE, ALUMINUM HYDROXIDE, STEARIC ACID, DISTEARDIMONIUM HECTORITE, TRIETHOXYCAPRYLYLSILANE, ETHYLHEXYL PALMITATE, LECITHIN, ISOSTEARIC ACID, ISOPROPYL PALMITATE, PHENOXYETHANOL, POLYGLYCERYL-3 POLYRICINOLEATE, ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, DIMETHICONE, DISODIUM EDTA, TRIMETHYLSILOXYSILICATE, ETHYLHEXYLGLYCERIN, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, AQUA/WATER/EAU, SILICA, CAMELLIA JAPONICA SEED OIL, CAMELLIA SINENSIS LEAF EXTRACT, CAPRYLYL GLYCOL, 1,2-HEXANEDIOL, PARFUM/FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES (CI 77492, CI 77491, CI 77499)

OTHER INFORMATION

Protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - 104 LIGHT/MEDIUM (PINK)

COLOR CONTROL CUSHION COMPACT
Broad Spectrum SPF 50+
Sunscreen

AMOREPACIFIC

Net Wt. 1.05 OZ./30 g(15 gx2) e

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - 104 LIGHT/MEDIUM (PINK)

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - 106 MEDIUM (PINK)

COLOR CONTROL CUSHION COMPACT
Broad Spectrum SPF 50+
Sunscreen

AMOREPACIFIC

Net Wt. 1.05 OZ./30 g(15 gx2) e

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - 106 MEDIUM (PINK)

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - 204 LIGHT/MEDIUM (YELLOW)

COLOR CONTROL CUSHION COMPACT
Broad Spectrum SPF 50+
Sunscreen

AMOREPACIFIC

Net Wt. 1.05 OZ./30 g(15 gx2) e

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - 204 LIGHT/MEDIUM (YELLOW)

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - 208 MEDIUM (YELLOW)

COLOR CONTROL CUSHION COMPACT
Broad Spectrum SPF 50+
Sunscreen

AMOREPACIFIC

Net Wt. 1.05 OZ./30 g(15 gx2) e

PRINCIPAL DISPLAY PANEL - 30 g Container Carton - 208 MEDIUM (YELLOW)

AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.104
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43419-511
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.05 g in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.6225 g in 15 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.47 g in 15 g

Ingredient Name	Strength
Inactive Ingredients
PHYLLOSTACHYS RETICULATA RESIN (UNII: KX390ME4SP)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
ALCOHOL (UNII: 3K9958V90M)
ARBUTIN (UNII: C5INA23HXF)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
ISOSTEARIC ACID (UNII: X33R8U0062)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43419-511-21	2 in 1 CARTON	12/05/2012
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC:43419-511-33	1 in 1 CARTON	08/01/2018	08/31/2019
2		5 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/05/2012

AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.106
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43419-512
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.05 g in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.6225 g in 15 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.47 g in 15 g

Ingredient Name	Strength
Inactive Ingredients
PHYLLOSTACHYS RETICULATA RESIN (UNII: KX390ME4SP)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
ALCOHOL (UNII: 3K9958V90M)
ARBUTIN (UNII: C5INA23HXF)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
ISOSTEARIC ACID (UNII: X33R8U0062)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43419-512-21	2 in 1 CARTON	12/05/2012
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/05/2012

AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.204
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43419-513
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.05 g in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.6225 g in 15 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.47 g in 15 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PHYLLOSTACHYS RETICULATA RESIN (UNII: KX390ME4SP)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
ALCOHOL (UNII: 3K9958V90M)
ARBUTIN (UNII: C5INA23HXF)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
ISOSTEARIC ACID (UNII: X33R8U0062)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43419-513-21	2 in 1 CARTON	12/05/2012
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC:43419-513-33	1 in 1 CARTON	08/01/2018	08/31/2019
2		5 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/05/2012

AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.208
octinoxate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43419-514
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.05 g in 15 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.6225 g in 15 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.47 g in 15 g

Ingredient Name	Strength
Inactive Ingredients
PHYLLOSTACHYS RETICULATA RESIN (UNII: KX390ME4SP)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
ALCOHOL (UNII: 3K9958V90M)
ARBUTIN (UNII: C5INA23HXF)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
ISOSTEARIC ACID (UNII: X33R8U0062)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:43419-514-21	2 in 1 CARTON	12/05/2012
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/05/2012

Labeler - AMOREPACIFIC CORPORATION (631035289)

Name	Address	ID/FEI	Business Operations
Establishment
AMOREPACIFIC CORPORATION		694894112	manufacture(43419-511, 43419-512, 43419-513, 43419-514)