SULWHASOO PERFECTING CUSHION NO. 21: Package Insert and Label Information (Page 2 of 2)

​PRINCIPAL DISPLAY PANEL — NO. 31 HONEY(PINK)

Sulwhasoo

PERFECTING CUSHION
BROAD SPECTRUM 50+ SUNSCREEN

NO. 31 HONEY(PINK)

30 g(15 g x 2) / Net wt. 1.05 oz.

no. 31
(click image for full-size original)
p
(click image for full-size original)
in
(click image for full-size original)

​PRINCIPAL DISPLAY PANEL — NO. 33 HONEY(BEIGE)

Sulwhasoo

PERFECTING CUSHION BROAD SPECTRUM 50+ SUNSCREEN

NO. 33

HONEY(BEIGE)

30 g(15 g x 2) / Net wt. 1.05 oz.

No. 33
(click image for full-size original)
p
(click image for full-size original)
in
(click image for full-size original)

​PRINCIPAL DISPLAY PANEL — NO. 37 AMBER(BEIGE)

Sulwhasoo

PERFECTING CUSHION
BROAD SPECTRUM 50+ SUNSCREEN

NO. 37 AMBER(BEIGE)

30 g(15 g x 2) / Net wt. 1.05 oz.

no. 37
(click image for full-size original)
p
(click image for full-size original)
in
(click image for full-size original)
SULWHASOO PERFECTING CUSHION NO. 21 octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-077
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 2.1 g in 30 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.245 g in 30 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 2.94 g in 30 g
Inactive Ingredients
Ingredient Name Strength
HYALURONATE SODIUM
TOCOPHEROL
PHENOXYETHANOL
WATER
CYCLOMETHICONE 5
CYCLOMETHICONE 6
PHENYL TRIMETHICONE
PEG-10 DIMETHICONE (600 CST)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
NIACINAMIDE
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
GLYCERIN
PROPANEDIOL
POLY(METHYL METHACRYLATE; 450000 MW)
POLYHYDROXYSTEARIC ACID (2300 MW)
FERRIC OXIDE YELLOW
ALUMINUM HYDROXIDE
SODIUM CHLORIDE
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2)
STEARIC ACID
TRIETHOXYCAPRYLYLSILANE
DISTEARDIMONIUM HECTORITE
HYDROGENATED SOYBEAN LECITHIN
BUTYLENE GLYCOL
ETHYLHEXYL PALMITATE
ISOSTEARIC ACID
ISOPROPYL PALMITATE
POLYSORBATE 80
CAPRYLYL GLYCOL
FERRIC OXIDE RED
LECITHIN, SOYBEAN
ETHYLHEXYLGLYCERIN
GLYCERYL CAPRYLATE
FERROSOFERRIC OXIDE
EDETATE DISODIUM (EDETIC ACID)
ADENOSINE
HONEY
NELUMBO NUCIFERA FLOWER
POLYGONATUM ODORATUM ROOT
LILIUM CANDIDUM BULB
.BETA.-D-GLUCOPYRANOSE
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43419-077-31 2 CONTAINER in 1 CARTON contains a CONTAINER
1 15 g in 1 CONTAINER This package is contained within the CARTON (43419-077-31)
2 NDC:43419-077-39 2 CONTAINER in 1 CARTON contains a CONTAINER
2 15 g in 1 CONTAINER This package is contained within the CARTON (43419-077-39)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/15/2019
SULWHASOO PERFECTING CUSHION NO. 27 octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-080
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 2.1 g in 30 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.245 g in 30 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 2.94 g in 30 g
Inactive Ingredients
Ingredient Name Strength
HYALURONATE SODIUM
TOCOPHEROL
PHENOXYETHANOL
WATER
CYCLOMETHICONE 5
CYCLOMETHICONE 6
PHENYL TRIMETHICONE
PEG-10 DIMETHICONE (600 CST)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
NIACINAMIDE
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
GLYCERIN
PROPANEDIOL
POLY(METHYL METHACRYLATE; 450000 MW)
POLYHYDROXYSTEARIC ACID (2300 MW)
FERRIC OXIDE YELLOW
ALUMINUM HYDROXIDE
SODIUM CHLORIDE
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2)
STEARIC ACID
TRIETHOXYCAPRYLYLSILANE
DISTEARDIMONIUM HECTORITE
HYDROGENATED SOYBEAN LECITHIN
BUTYLENE GLYCOL
ETHYLHEXYL PALMITATE
LECITHIN, SOYBEAN
ISOSTEARIC ACID
ISOPROPYL PALMITATE
POLYSORBATE 80
CAPRYLYL GLYCOL
FERRIC OXIDE RED
ETHYLHEXYLGLYCERIN
GLYCERYL CAPRYLATE
FERROSOFERRIC OXIDE
EDETATE DISODIUM (EDETIC ACID)
ADENOSINE
HONEY
NELUMBO NUCIFERA FLOWER
POLYGONATUM ODORATUM ROOT
LILIUM CANDIDUM BULB
.BETA.-D-GLUCOPYRANOSE
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43419-080-31 2 CONTAINER in 1 CARTON contains a CONTAINER
1 15 g in 1 CONTAINER This package is contained within the CARTON (43419-080-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/15/2019
SULWHASOO PERFECTING CUSHION NO. 31 octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-081
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 2.1 g in 30 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.245 g in 30 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 2.94 g in 30 g
Inactive Ingredients
Ingredient Name Strength
HYALURONATE SODIUM
TOCOPHEROL
PHENOXYETHANOL
WATER
CYCLOMETHICONE 5
CYCLOMETHICONE 6
PHENYL TRIMETHICONE
PEG-10 DIMETHICONE (600 CST)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
NIACINAMIDE
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
GLYCERIN
PROPANEDIOL
POLY(METHYL METHACRYLATE; 450000 MW)
POLYHYDROXYSTEARIC ACID (2300 MW)
FERRIC OXIDE YELLOW
ALUMINUM HYDROXIDE
SODIUM CHLORIDE
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2)
STEARIC ACID
TRIETHOXYCAPRYLYLSILANE
DISTEARDIMONIUM HECTORITE
HYDROGENATED SOYBEAN LECITHIN
BUTYLENE GLYCOL
ETHYLHEXYL PALMITATE
LECITHIN, SOYBEAN
ISOSTEARIC ACID
ISOPROPYL PALMITATE
POLYSORBATE 80
CAPRYLYL GLYCOL
FERRIC OXIDE RED
ETHYLHEXYLGLYCERIN
GLYCERYL CAPRYLATE
FERROSOFERRIC OXIDE
EDETATE DISODIUM (EDETIC ACID)
ADENOSINE
HONEY
NELUMBO NUCIFERA FLOWER
POLYGONATUM ODORATUM ROOT
LILIUM CANDIDUM BULB
.BETA.-D-GLUCOPYRANOSE
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43419-081-31 2 CONTAINER in 1 CARTON contains a CONTAINER
1 15 g in 1 CONTAINER This package is contained within the CARTON (43419-081-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/15/2019
SULWHASOO PERFECTING CUSHION NO. 33 octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-082
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 2.1 g in 30 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.245 g in 30 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 2.94 g in 30 g
Inactive Ingredients
Ingredient Name Strength
HYALURONATE SODIUM
TOCOPHEROL
PHENOXYETHANOL
WATER
CYCLOMETHICONE 5
CYCLOMETHICONE 6
PHENYL TRIMETHICONE
PEG-10 DIMETHICONE (600 CST)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
NIACINAMIDE
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
GLYCERIN
PROPANEDIOL
POLY(METHYL METHACRYLATE; 450000 MW)
POLYHYDROXYSTEARIC ACID (2300 MW)
FERRIC OXIDE YELLOW
ALUMINUM HYDROXIDE
SODIUM CHLORIDE
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2)
STEARIC ACID
TRIETHOXYCAPRYLYLSILANE
DISTEARDIMONIUM HECTORITE
HYDROGENATED SOYBEAN LECITHIN
BUTYLENE GLYCOL
ETHYLHEXYL PALMITATE
ISOSTEARIC ACID
ISOPROPYL PALMITATE
POLYSORBATE 80
CAPRYLYL GLYCOL
FERRIC OXIDE RED
LECITHIN, SOYBEAN
ETHYLHEXYLGLYCERIN
GLYCERYL CAPRYLATE
FERROSOFERRIC OXIDE
EDETATE DISODIUM (EDETIC ACID)
ADENOSINE
HONEY
NELUMBO NUCIFERA FLOWER
POLYGONATUM ODORATUM ROOT
LILIUM CANDIDUM BULB
.BETA.-D-GLUCOPYRANOSE
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43419-082-31 2 CONTAINER in 1 CARTON contains a CONTAINER
1 15 g in 1 CONTAINER This package is contained within the CARTON (43419-082-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/15/2019 10/31/2021
SULWHASOO PERFECTING CUSHION NO. 15 octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-075
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 2.1 g in 30 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.245 g in 30 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 2.94 g in 30 g
Inactive Ingredients
Ingredient Name Strength
HYALURONATE SODIUM
TOCOPHEROL
PHENOXYETHANOL
WATER
CYCLOMETHICONE 5
CYCLOMETHICONE 6
NIACINAMIDE
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
GLYCERIN
PROPANEDIOL
POLY(METHYL METHACRYLATE; 450000 MW)
POLYHYDROXYSTEARIC ACID (2300 MW)
FERRIC OXIDE YELLOW
ALUMINUM HYDROXIDE
SODIUM CHLORIDE
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2)
STEARIC ACID
TRIETHOXYCAPRYLYLSILANE
DISTEARDIMONIUM HECTORITE
HYDROGENATED SOYBEAN LECITHIN
BUTYLENE GLYCOL
ETHYLHEXYL PALMITATE
ISOSTEARIC ACID
ISOPROPYL PALMITATE
POLYSORBATE 80
CAPRYLYL GLYCOL
FERRIC OXIDE RED
LECITHIN, SOYBEAN
ETHYLHEXYLGLYCERIN
GLYCERYL CAPRYLATE
FERROSOFERRIC OXIDE
EDETATE DISODIUM (EDETIC ACID)
ADENOSINE
HONEY
NELUMBO NUCIFERA FLOWER
POLYGONATUM ODORATUM ROOT
LILIUM CANDIDUM BULB
.BETA.-D-GLUCOPYRANOSE
ALCOHOL
PHENYL TRIMETHICONE
PEG-10 DIMETHICONE (600 CST)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43419-075-31 2 CONTAINER in 1 CARTON contains a CONTAINER
1 15 g in 1 CONTAINER This package is contained within the CARTON (43419-075-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/15/2019
SULWHASOO PERFECTING CUSHION NO. 17 octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-076
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 2.1 g in 30 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.245 g in 30 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 2.94 g in 30 g
Inactive Ingredients
Ingredient Name Strength
HYALURONATE SODIUM
TOCOPHEROL
PHENOXYETHANOL
WATER
CYCLOMETHICONE 5
CYCLOMETHICONE 6
PHENYL TRIMETHICONE
PEG-10 DIMETHICONE (600 CST)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
NIACINAMIDE
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
GLYCERIN
PROPANEDIOL
POLY(METHYL METHACRYLATE; 450000 MW)
POLYHYDROXYSTEARIC ACID (2300 MW)
FERRIC OXIDE YELLOW
ALUMINUM HYDROXIDE
SODIUM CHLORIDE
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2)
STEARIC ACID
TRIETHOXYCAPRYLYLSILANE
DISTEARDIMONIUM HECTORITE
HYDROGENATED SOYBEAN LECITHIN
BUTYLENE GLYCOL
ETHYLHEXYL PALMITATE
LECITHIN, SOYBEAN
ISOSTEARIC ACID
ISOPROPYL PALMITATE
POLYSORBATE 80
CAPRYLYL GLYCOL
FERRIC OXIDE RED
ETHYLHEXYLGLYCERIN
GLYCERYL CAPRYLATE
FERROSOFERRIC OXIDE
EDETATE DISODIUM (EDETIC ACID)
ADENOSINE
HONEY
NELUMBO NUCIFERA FLOWER
POLYGONATUM ODORATUM ROOT
LILIUM CANDIDUM BULB
.BETA.-D-GLUCOPYRANOSE
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43419-076-31 2 CONTAINER in 1 CARTON contains a CONTAINER
1 15 g in 1 CONTAINER This package is contained within the CARTON (43419-076-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/15/2019 12/25/2021
SULWHASOO PERFECTING CUSHION NO. 23 octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-078
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 2.1 g in 30 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.245 g in 30 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 2.94 g in 30 g
Inactive Ingredients
Ingredient Name Strength
HYALURONATE SODIUM
TOCOPHEROL
PHENOXYETHANOL
WATER
CYCLOMETHICONE 5
CYCLOMETHICONE 6
PHENYL TRIMETHICONE
PEG-10 DIMETHICONE (600 CST)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
NIACINAMIDE
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
GLYCERIN
PROPANEDIOL
POLY(METHYL METHACRYLATE; 450000 MW)
POLYHYDROXYSTEARIC ACID (2300 MW)
FERRIC OXIDE YELLOW
ALUMINUM HYDROXIDE
SODIUM CHLORIDE
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2)
STEARIC ACID
TRIETHOXYCAPRYLYLSILANE
DISTEARDIMONIUM HECTORITE
HYDROGENATED SOYBEAN LECITHIN
BUTYLENE GLYCOL
ETHYLHEXYL PALMITATE
LECITHIN, SOYBEAN
ISOSTEARIC ACID
ISOPROPYL PALMITATE
POLYSORBATE 80
CAPRYLYL GLYCOL
FERRIC OXIDE RED
ETHYLHEXYLGLYCERIN
GLYCERYL CAPRYLATE
FERROSOFERRIC OXIDE
EDETATE DISODIUM (EDETIC ACID)
ADENOSINE
HONEY
NELUMBO NUCIFERA FLOWER
POLYGONATUM ODORATUM ROOT
LILIUM CANDIDUM BULB
.BETA.-D-GLUCOPYRANOSE
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43419-078-31 2 CONTAINER in 1 CARTON contains a CONTAINER
1 15 g in 1 CONTAINER This package is contained within the CARTON (43419-078-31)
2 NDC:43419-078-39 2 CONTAINER in 1 CARTON contains a CONTAINER
2 15 g in 1 CONTAINER This package is contained within the CARTON (43419-078-39)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/15/2019
SULWHASOO PERFECTING CUSHION NO. 37 octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-083
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 2.1 g in 30 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.245 g in 30 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 2.94 g in 30 g
Inactive Ingredients
Ingredient Name Strength
HYALURONATE SODIUM
TOCOPHEROL
PHENOXYETHANOL
WATER
CYCLOMETHICONE 5
CYCLOMETHICONE 6
PHENYL TRIMETHICONE
PEG-10 DIMETHICONE (600 CST)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
NIACINAMIDE
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
GLYCERIN
PROPANEDIOL
POLY(METHYL METHACRYLATE; 450000 MW)
POLYHYDROXYSTEARIC ACID (2300 MW)
FERRIC OXIDE YELLOW
ALUMINUM HYDROXIDE
SODIUM CHLORIDE
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2)
STEARIC ACID
TRIETHOXYCAPRYLYLSILANE
DISTEARDIMONIUM HECTORITE
HYDROGENATED SOYBEAN LECITHIN
BUTYLENE GLYCOL
ETHYLHEXYL PALMITATE
ISOSTEARIC ACID
ISOPROPYL PALMITATE
POLYSORBATE 80
CAPRYLYL GLYCOL
FERRIC OXIDE RED
LECITHIN, SOYBEAN
ETHYLHEXYLGLYCERIN
GLYCERYL CAPRYLATE
FERROSOFERRIC OXIDE
EDETATE DISODIUM (EDETIC ACID)
ADENOSINE
HONEY
NELUMBO NUCIFERA FLOWER
POLYGONATUM ODORATUM ROOT
LILIUM CANDIDUM BULB
.BETA.-D-GLUCOPYRANOSE
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43419-083-31 2 CONTAINER in 1 CARTON contains a CONTAINER
1 15 g in 1 CONTAINER This package is contained within the CARTON (43419-083-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/15/2019
SULWHASOO PERFECTING CUSHION NO. 11 octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-074
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 2.1 g in 30 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.245 g in 30 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 2.94 g in 30 g
Inactive Ingredients
Ingredient Name Strength
HYALURONATE SODIUM
TOCOPHEROL
PHENOXYETHANOL
WATER
CYCLOMETHICONE 5
CYCLOMETHICONE 6
PHENYL TRIMETHICONE
PEG-10 DIMETHICONE (600 CST)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
NIACINAMIDE
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
GLYCERIN
PROPANEDIOL
POLY(METHYL METHACRYLATE; 450000 MW)
POLYHYDROXYSTEARIC ACID (2300 MW)
FERRIC OXIDE YELLOW
ALUMINUM HYDROXIDE
SODIUM CHLORIDE
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2)
STEARIC ACID
TRIETHOXYCAPRYLYLSILANE
DISTEARDIMONIUM HECTORITE
LECITHIN, SOYBEAN
BUTYLENE GLYCOL
ETHYLHEXYL PALMITATE
HYDROGENATED SOYBEAN LECITHIN
ISOSTEARIC ACID
ISOPROPYL PALMITATE
POLYSORBATE 80
CAPRYLYL GLYCOL
FERRIC OXIDE RED
ETHYLHEXYLGLYCERIN
GLYCERYL CAPRYLATE
FERROSOFERRIC OXIDE
EDETATE DISODIUM (EDETIC ACID)
ADENOSINE
HONEY
NELUMBO NUCIFERA FLOWER
POLYGONATUM ODORATUM ROOT
LILIUM CANDIDUM BULB
.BETA.-D-GLUCOPYRANOSE
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43419-074-31 2 CONTAINER in 1 CARTON contains a CONTAINER
1 15 g in 1 CONTAINER This package is contained within the CARTON (43419-074-31)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/15/2019 11/27/2021
SULWHASOO PERFECTING CUSHION NO. 25 octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-079
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 2.1 g in 30 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.245 g in 30 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 2.94 g in 30 g
Inactive Ingredients
Ingredient Name Strength
HYALURONATE SODIUM
TOCOPHEROL
PHENOXYETHANOL
WATER
CYCLOMETHICONE 5
CYCLOMETHICONE 6
PHENYL TRIMETHICONE
PEG-10 DIMETHICONE (600 CST)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
NIACINAMIDE
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
GLYCERIN
PROPANEDIOL
POLY(METHYL METHACRYLATE; 450000 MW)
POLYHYDROXYSTEARIC ACID (2300 MW)
FERRIC OXIDE YELLOW
ALUMINUM HYDROXIDE
SODIUM CHLORIDE
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2)
STEARIC ACID
TRIETHOXYCAPRYLYLSILANE
DISTEARDIMONIUM HECTORITE
HYDROGENATED SOYBEAN LECITHIN
BUTYLENE GLYCOL
ETHYLHEXYL PALMITATE
ISOSTEARIC ACID
ISOPROPYL PALMITATE
POLYSORBATE 80
CAPRYLYL GLYCOL
FERRIC OXIDE RED
LECITHIN, SOYBEAN
ETHYLHEXYLGLYCERIN
GLYCERYL CAPRYLATE
FERROSOFERRIC OXIDE
EDETATE DISODIUM (EDETIC ACID)
ADENOSINE
HONEY
NELUMBO NUCIFERA FLOWER
POLYGONATUM ODORATUM ROOT
LILIUM CANDIDUM BULB
.BETA.-D-GLUCOPYRANOSE
ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43419-079-31 2 CONTAINER in 1 CARTON contains a CONTAINER
1 15 g in 1 CONTAINER This package is contained within the CARTON (43419-079-31)
2 NDC:43419-079-39 2 CONTAINER in 1 CARTON contains a CONTAINER
2 15 g in 1 CONTAINER This package is contained within the CARTON (43419-079-39)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/15/2019
Labeler — Amorepacific Corporation (631035289)
Establishment
Name Address ID/FEI Operations
Amorepacific Corporation 694894112 manufacture (43419-074), manufacture (43419-075), manufacture (43419-076), manufacture (43419-077), manufacture (43419-078), manufacture (43419-079), manufacture (43419-080), manufacture (43419-081), manufacture (43419-082), manufacture (43419-083)

Revised: 04/2021 Amorepacific Corporation

Page 2 of 2 1 2

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.