AMOREPACIFIC AGE CORRECTING FOUNDATION CUSHION 102- octinoxate lotion AMOREPACIFIC AGE CORRECTING FOUNDATION CUSHION 104- octinoxate lotion AMOREPACIFIC AGE CORRECTING FOUNDATION CUSHION 106- octinoxate lotion AMOREPACIFIC AGE CORRECTING FOUNDATION CUSHION 204- octinoxate lotion AMOREPACIFIC AGE CORRECTING FOUNDATION CUSHION 208- octinoxate lotion

Amorepacific Age Correcting Foundation Cushion 208 by

Drug Labeling and Warnings

Amorepacific Age Correcting Foundation Cushion 208 by is a Otc medication manufactured, distributed, or labeled by AMOREPACIFIC CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENTS W/W

OCTINOXATE 6.5%

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, regu-larly 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

CAMELLIA SINENSIS LEAF WATER, TITANIUM DIOXIDE (CI 77891), BUTYLENE GLYCOL, CYCLOPENTASILOXANE, METHYL TRIMETHICONE, PHENYL TRIMETHICONE, TRIMETHYLSILOXYSILICATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, CYCLOHEXASILOXANE, HYDROGENATED POLYDECENE, PEG-10 DIMETHICONE, ARBUTIN, CETYL ETHYLHEXANOATE, POLYMETHYL METHACRYLATE, ALCOHOL, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, DISTEARDIMONIUM HECTORITE, IRON OXIDES (CI 77492), SODIUM CHLORIDE, METHYL METHACRYLATE CROSSPOLYMER, POLYPROPYLSILSESQUIOXANE, IRON OXIDES (CI 77491), GLYCERIN, ALUMINUM HYDROXIDE, FRAGRANCE / PARFUM, TRIETHOXYCAPRYLYLSILANE, IRON OXIDES (CI 77499), PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, ACRYLATES/STEARYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, DIMETHICONE, CYCLOMETHICONE, DISODIUM EDTA, ADENOSINE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, WATER / AQUA / EAU, POLYETHYLENE, PEG/PPG-20/15 DIMETHICONE, PHENYL METHICONE, CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROGENATED LECITHIN, CAMELLIA SINENSIS LEAF EXTRACT, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, TOCOPHEROL, CAPRYLYL GLYCOL, 1,2-HEXANEDIOL

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - 102 Light (Pink)

AMOREPACIFIC

AGE CORRECTING FOUNDATION CUSHION
Broad Spectrum SPF 25
Sunscreen

102 LIGHT (PINK)

Net Wt. 1.05 OZ. / 30 g(15 g x 2) e

PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - 104 Light/Medium (Pink)

AMOREPACIFIC

AGE CORRECTING FOUNDATION CUSHION
Broad Spectrum SPF 25
Sunscreen

104 LIGHT/MEDIUM (PINK)

Net Wt. 1.05 OZ. / 30 g(15 g x 2) e

PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - 106 Medium (Pink)

AMOREPACIFIC

AGE CORRECTING FOUNDATION CUSHION
Broad Spectrum SPF 25
Sunscreen

106 MEDIUM (PINK)

Net Wt. 1.05 OZ. / 30 g(15 g x 2) e

PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - 204 Light/Medium (Yellow)

AMOREPACIFIC

AGE CORRECTING FOUNDATION CUSHION
Broad Spectrum SPF 25
Sunscreen

204 LIGHT/MEDIUM (YELLOW)

Net Wt. 1.05 OZ. / 30 g(15 g x 2) e

PRINCIPAL DISPLAY PANEL - 15 g x 2 Container Carton - 208 Medium (Yellow)

AMOREPACIFIC

AGE CORRECTING FOUNDATION CUSHION
Broad Spectrum SPF 25
Sunscreen

208 MEDIUM (YELLOW)

Net Wt. 1.05 OZ. / 30 g(15 g x 2) e

INGREDIENTS AND APPEARANCE

AMOREPACIFIC AGE CORRECTING FOUNDATION CUSHION 102 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-523
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.975 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
TEA LEAF OIL (UNII: VC855RRT77)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ARBUTIN (UNII: C5INA23HXF)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
ALCOHOL (UNII: 3K9958V90M)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ADENOSINE (UNII: K72T3FS567)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-523-31	2 in 1 CARTON	10/19/2015
1		15 g in 1 CONTAINER; 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	10/19/2015

AMOREPACIFIC AGE CORRECTING FOUNDATION CUSHION 104 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-524
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.975 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
TEA LEAF OIL (UNII: VC855RRT77)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
ARBUTIN (UNII: C5INA23HXF)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALCOHOL (UNII: 3K9958V90M)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ADENOSINE (UNII: K72T3FS567)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-524-31	2 in 1 CARTON	10/19/2015
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 43419-524-33	1 in 1 CARTON	10/19/2015	08/31/2019
2		5 g in 1 CONTAINER; 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	10/19/2015

AMOREPACIFIC AGE CORRECTING FOUNDATION CUSHION 106 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-525
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.975 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
TEA LEAF OIL (UNII: VC855RRT77)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ARBUTIN (UNII: C5INA23HXF)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
ALCOHOL (UNII: 3K9958V90M)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ADENOSINE (UNII: K72T3FS567)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-525-31	2 in 1 CARTON	10/19/2015
1		15 g in 1 CONTAINER; 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	10/19/2015

AMOREPACIFIC AGE CORRECTING FOUNDATION CUSHION 204 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-526
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.975 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
TEA LEAF OIL (UNII: VC855RRT77)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ARBUTIN (UNII: C5INA23HXF)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALCOHOL (UNII: 3K9958V90M)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ADENOSINE (UNII: K72T3FS567)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-526-31	2 in 1 CARTON	10/19/2015
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 43419-526-33	1 in 1 CARTON	10/19/2015	08/31/2019
2		5 g in 1 CONTAINER; 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	10/19/2015

AMOREPACIFIC AGE CORRECTING FOUNDATION CUSHION 208 
octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-527
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.975 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
TEA LEAF OIL (UNII: VC855RRT77)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
ARBUTIN (UNII: C5INA23HXF)
ALCOHOL (UNII: 3K9958V90M)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
GLYCERIN (UNII: PDC6A3C0OX)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE (UNII: NMQ347994Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ADENOSINE (UNII: K72T3FS567)
WATER (UNII: 059QF0KO0R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-527-31	2 in 1 CARTON	10/19/2015
1		15 g in 1 CONTAINER; 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	10/19/2015

Labeler - AMOREPACIFIC CORPORATION (631035289)

Establishment
Name	Address	ID/FEI	Business Operations
AMOREPACIFIC CORPORATION		694894112	manufacture(43419-523, 43419-524, 43419-525, 43419-526, 43419-527)