Sulwhasoo Perfecting Cushion No.2 - FDA Label NDC 43419-090

The following Structured Product Label (SPL) was submitted to the FDA by Amorepacific Corporation for the product Sulwhasoo Perfecting Cushion No.25n1 Amber (NDC 43419-090). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Homosalate 7%
Octinoxate 4.9965%
Titanium dioxide 4.05%

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

Otc - Do Not Use

Do not use on broken skin.

Otc - When Using

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.

Directions

◼ Apply liberally 15 minutes before sun exposure.

◼ Children under 6 months of age : Ask a doctor.

◼ 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.

Other Information

Protect the product in this container from excessive heat and direct sun.
Sun alert : Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Inactive Ingredients

17N1	WATER / AQUA / EAU, TITANIUM DIOXIDE (CI 77891), CYCLOPENTASILOXANE, DIPHENYLSILOXY PHENYL TRIMETHICONE, PEG-10 DIMETHICONE, PROPANEDIOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, CYCLOHEXASILOXANE, TRIMETHYLSILOXYSILICATE, NIACINAMIDE, GLYCERIN, CAPRYLYL METHICONE, DISTEARDIMONIUM HECTORITE, POLYMETHYL METHACRYLATE, MAGNESIUM POTASSIUM FLUOROSILICATE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, IRON OXIDES (CI 77492), 1,2-HEXANEDIOL, BUTYLENE GLYCOL, SODIUM CHLORIDE, ALUMINA, SYNTHETIC FLUORPHLOGOPITE, GLYCERYL STEARATE CITRATE, FRAGRANCE / PARFUM, ACRYLATES/DIMETHICONE COPOLYMER, ALUMINUM HYDROXIDE, TRIETHOXYCAPRYLYLSILANE, POLYHYDROXYSTEARIC ACID, POLYSORBATE 80, IRON OXIDES (CI 77491), GLYCERYL CAPRYLATE, POLYPHENYLSILSESQUIOXANE, HYDROGENATED LECITHIN, ISODODECANE, SIMETHICONE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, IRON OXIDES (CI 77499), ETHYLHEXYL PALMITATE, LECITHIN, ISOSTEARIC ACID, ISOPROPYL PALMITATE, SODIUM HYALURONATE, DISODIUM EDTA, ADENOSINE, POLYSILICONE-11, POLYGLYCERYL-3 POLYRICINOLEATE, HONEY / MEL / MIEL, BETAINE, REHMANNIA GLUTINOSA ROOT EXTRACT, ALCOHOL DENAT., BHT, PAEONIA LACTIFLORA ROOT EXTRACT, LILIUM CANDIDUM BULB EXTRACT, HYDROGENATED POLY(C6-14 OLEFIN), POLYGONATUM ODORATUM RHIZOME EXTRACT, CETYL ETHYLHEXANOATE, HYALURONIC ACID, AMINOPROPYL TRIETHOXYSILANE, NELUMBO NUCIFERA FLOWER EXTRACT, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, TOCOPHEROL, CETEARYL ALCOHOL, SODIUM STEAROYL GLUTAMATE, RED 7 (CI 15850), BETA-GLUCAN, PRUNUS MUME FLOWER EXTRACT
21N1	WATER / AQUA / EAU, TITANIUM DIOXIDE (CI 77891), CYCLOPENTASILOXANE, DIPHENYLSILOXY PHENYL TRIMETHICONE, PEG-10 DIMETHICONE, PROPANEDIOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, CYCLOHEXASILOXANE, TRIMETHYLSILOXYSILICATE, NIACINAMIDE, GLYCERIN, CAPRYLYL METHICONE, IRON OXIDES (CI 77492), DISTEARDIMONIUM HECTORITE, MAGNESIUM POTASSIUM FLUOROSILICATE, ACRYLATES/ETHYLHEXYL ACRYLATE/ DIMETHICONE METHACRYLATE COPOLYMER, POLYMETHYL METHACRYLATE, 1,2-HEXANEDIOL, BUTYLENE GLYCOL, SODIUM CHLORIDE, ALUMINA, SYNTHETIC FLUORPHLOGOPITE, GLYCERYL STEARATE CITRATE, FRAGRANCE / PARFUM, ACRYLATES/DIMETHICONE COPOLYMER, ALUMINUM HYDROXIDE, TRIETHOXYCAPRYLYLSILANE, IRON OXIDES (CI 77491), POLYHYDROXYSTEARIC ACID, POLYSORBATE 80, GLYCERYL CAPRYLATE, POLYPHENYLSILSESQUIOXANE, HYDROGENATED LECITHIN, IRON OXIDES (CI 77499), ISODODECANE, SIMETHICONE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, ETHYLHEXYL PALMITATE, LECITHIN, ISOSTEARIC ACID, ISOPROPYL PALMITATE, SODIUM HYALURONATE, DISODIUM EDTA, ADENOSINE, POLYSILICONE-11, POLYGLYCERYL-3 POLYRICINOLEATE, HONEY / MEL / MIEL, BETAINE, REHMANNIA GLUTINOSA ROOT EXTRACT, ALCOHOL DENAT., BHT, PAEONIA LACTIFLORA ROOT EXTRACT, LILIUM CANDIDUM BULB EXTRACT, HYDROGENATED POLY(C6-14 OLEFIN), POLYGONATUM ODORATUM RHIZOME EXTRACT, CETYL ETHYLHEXANOATE, HYALURONIC ACID, AMINOPROPYL TRIETHOXYSILANE, NELUMBO NUCIFERA FLOWER EXTRACT, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, TOCOPHEROL, CETEARYL ALCOHOL, SODIUM STEAROYL GLUTAMATE, RED 7 (CI 15850), BETA-GLUCAN, PRUNUS MUME FLOWER EXTRACT
23N1	WATER / AQUA / EAU, TITANIUM DIOXIDE (CI 77891), CYCLOPENTASILOXANE, DIPHENYLSILOXY PHENYL TRIMETHICONE, PEG-10 DIMETHICONE, PROPANEDIOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, CYCLOHEXASILOXANE, TRIMETHYLSILOXYSILICATE, NIACINAMIDE, IRON OXIDES (CI 77492), GLYCERIN, CAPRYLYL METHICONE, DISTEARDIMONIUM HECTORITE, MAGNESIUM POTASSIUM FLUOROSILICATE, ACRYLATES/ETHYLHEXYL ACRYLATE/ DIMETHICONE METHACRYLATE COPOLYMER, 1,2-HEXANEDIOL, BUTYLENE GLYCOL, POLYMETHYL METHACRYLATE, SODIUM CHLORIDE, ALUMINA, SYNTHETIC FLUORPHLOGOPITE, GLYCERYL STEARATE CITRATE, IRON OXIDES (CI 77491), FRAGRANCE / PARFUM, ACRYLATES/DIMETHICONE COPOLYMER, TRIETHOXYCAPRYLYLSILANE, ALUMINUM HYDROXIDE, POLYHYDROXYSTEARIC ACID, POLYSORBATE 80, GLYCERYL CAPRYLATE, POLYPHENYLSILSESQUIOXANE, IRON OXIDES (CI 77499), HYDROGENATED LECITHIN, ISODODECANE, SIMETHICONE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, ETHYLHEXYL PALMITATE, LECITHIN, ISOSTEARIC ACID, ISOPROPYL PALMITATE, SODIUM HYALURONATE, DISODIUM EDTA, ADENOSINE, POLYSILICONE-11, POLYGLYCERYL-3 POLYRICINOLEATE, HONEY / MEL / MIEL, BETAINE, REHMANNIA GLUTINOSA ROOT EXTRACT, ALCOHOL DENAT., BHT, PAEONIA LACTIFLORA ROOT EXTRACT, LILIUM CANDIDUM BULB EXTRACT, HYDROGENATED POLY(C6-14 OLEFIN), POLYGONATUM ODORATUM RHIZOME EXTRACT, CETYL ETHYLHEXANOATE, HYALURONIC ACID, AMINOPROPYL TRIETHOXYSILANE, NELUMBO NUCIFERA FLOWER EXTRACT, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, TOCOPHEROL, CETEARYL ALCOHOL, SODIUM STEAROYL GLUTAMATE, RED 7 (CI 15850), BETA-GLUCAN, PRUNUS MUME FLOWER EXTRACT
25N1	WATER / AQUA / EAU, TITANIUM DIOXIDE (CI 77891), CYCLOPENTASILOXANE, DIPHENYLSILOXY PHENYL TRIMETHICONE, PEG-10 DIMETHICONE, PROPANEDIOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, CYCLOHEXASILOXANE, TRIMETHYLSILOXYSILICATE, NIACINAMIDE, IRON OXIDES (CI 77492), GLYCERIN, CAPRYLYL METHICONE, DISTEARDIMONIUM HECTORITE, MAGNESIUM POTASSIUM FLUOROSILICATE, ACRYLATES/ETHYLHEXYL ACRYLATE/ DIMETHICONE METHACRYLATE COPOLYMER, 1,2-HEXANEDIOL, BUTYLENE GLYCOL, POLYMETHYL METHACRYLATE, SODIUM CHLORIDE, ALUMINA, SYNTHETIC FLUORPHLOGOPITE, IRON OXIDES (CI 77491), GLYCERYL STEARATE CITRATE, FRAGRANCE / PARFUM, ACRYLATES/DIMETHICONE COPOLYMER, TRIETHOXYCAPRYLYLSILANE, ALUMINUM HYDROXIDE, IRON OXIDES (CI 77499), POLYHYDROXYSTEARIC ACID, POLYSORBATE 80, GLYCERYL CAPRYLATE, POLYPHENYLSILSESQUIOXANE, HYDROGENATED LECITHIN, ISODODECANE, SIMETHICONE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, ETHYLHEXYL PALMITATE, LECITHIN, ISOSTEARIC ACID, ISOPROPYL PALMITATE, SODIUM HYALURONATE, DISODIUM EDTA, ADENOSINE, POLYSILICONE-11, POLYGLYCERYL-3 POLYRICINOLEATE, HONEY / MEL / MIEL, BETAINE, REHMANNIA GLUTINOSA ROOT EXTRACT, ALCOHOL DENAT., BHT, PAEONIA LACTIFLORA ROOT EXTRACT, LILIUM CANDIDUM BULB EXTRACT, HYDROGENATED POLY(C6-14 OLEFIN), POLYGONATUM ODORATUM RHIZOME EXTRACT, CETYL ETHYLHEXANOATE, HYALURONIC ACID, AMINOPROPYL TRIETHOXYSILANE, NELUMBO NUCIFERA FLOWER EXTRACT, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, TOCOPHEROL, CETEARYL ALCOHOL, SODIUM STEAROYL GLUTAMATE, RED 7 (CI 15850), BETA-GLUCAN, PRUNUS MUME FLOWER EXTRACT
31N1	WATER / AQUA / EAU, TITANIUM DIOXIDE (CI 77891), CYCLOPENTASILOXANE, DIPHENYLSILOXY PHENYL TRIMETHICONE, PEG-10 DIMETHICONE, PROPANEDIOL, IRON OXIDES (CI 77492), BUTYLENE GLYCOL DICAPRYLATE/ DICAPRATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, CYCLOHEXASILOXANE, TRIMETHYLSILOXYSILICATE, NIACINAMIDE, GLYCERIN, CAPRYLYL METHICONE, DISTEARDIMONIUM HECTORITE, MAGNESIUM POTASSIUM FLUOROSILICATE, ACRYLATES/ETHYLHEXYL ACRYLATE/DI METHICONE METHACRYLATE COPOLYMER, POLYMETHYL METHACRYLATE, 1,2-HEXANEDIOL, BUTYLENE GLYCOL, IRON OXIDES (CI 77491), SODIUM CHLORIDE, ALUMINA, SYNTHETIC FLUORPHLOGOPITE, GLYCERYL STEARATE CITRATE, FRAGRANCE / PARFUM, ACRYLATES/DIMETHICONE COPOLYMER, TRIETHOXYCAPRYLYLSILANE, IRON OXIDES (CI 77499), ALUMINUM HYDROXIDE, POLYHYDROXYSTEARIC ACID, POLYSORBATE 80, GLYCERYL CAPRYLATE, POLYPHENYLSILSESQUIOXANE, HYDROGENATED LECITHIN, ISODODECANE, SIMETHICONE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, ETHYLHEXYL PALMITATE, LECITHIN, ISOSTEARIC ACID, ISOPROPYL PALMITATE, SODIUM HYALURONATE, DISODIUM EDTA, ADENOSINE, POLYSILICONE-11, POLYGLYCERYL-3 POLYRICINOLEATE, HONEY / MEL / MIEL, BETAINE, REHMANNIA GLUTINOSA ROOT EXTRACT, ALCOHOL DENAT., BHT, PAEONIA LACTIFLORA ROOT EXTRACT, LILIUM CANDIDUM BULB EXTRACT, HYDROGENATED POLY(C6-14 OLEFIN), POLYGONATUM ODORATUM RHIZOME EXTRACT, CETYL ETHYLHEXANOATE, HYALURONIC ACID, AMINOPROPYL TRIETHOXYSILANE, NELUMBO NUCIFERA FLOWER EXTRACT, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, TOCOPHEROL, CETEARYL ALCOHOL, SODIUM STEAROYL GLUTAMATE, RED 7 (CI 15850), BETA-GLUCAN, PRUNUS MUME FLOWER EXTRACT
33C1	WATER / AQUA / EAU, TITANIUM DIOXIDE (CI 77891), CYCLOPENTASILOXANE, DIPHENYLSILOXY PHENYL TRIMETHICONE, PEG-10 DIMETHICONE, PROPANEDIOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, IRON OXIDES (CI 77492), CYCLOHEXASILOXANE, TRIMETHYLSILOXYSILICATE, NIACINAMIDE, GLYCERIN, CAPRYLYL METHICONE, DISTEARDIMONIUM HECTORITE, MAGNESIUM POTASSIUM FLUOROSILICATE, ACRYLATES/ETHYLHEXYL ACRYLATE/ DIMETHICONE METHACRYLATE COPOLYMER, IRON OXIDES (CI 77491), POLYMETHYL METHACRYLATE, 1,2-HEXANEDIOL, BUTYLENE GLYCOL, SODIUM CHLORIDE, ALUMINA, SYNTHETIC FLUORPHLOGOPITE, GLYCERYL STEARATE CITRATE, FRAGRANCE / PARFUM, ACRYLATES/DIMETHICONE COPOLYMER, TRIETHOXYCAPRYLYLSILANE, IRON OXIDES (CI 77499), ALUMINUM HYDROXIDE, POLYHYDROXYSTEARIC ACID, POLYSORBATE 80, GLYCERYL CAPRYLATE, POLYPHENYLSILSESQUIOXANE, HYDROGENATED LECITHIN, ISODODECANE, SIMETHICONE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, ETHYLHEXYL PALMITATE, LECITHIN, ISOSTEARIC ACID, ISOPROPYL PALMITATE, SODIUM HYALURONATE, DISODIUM EDTA, ADENOSINE, POLYGLYCERYL-3 POLYRICINOLEATE, POLYSILICONE-11, HONEY / MEL / MIEL, BETAINE, REHMANNIA GLUTINOSA ROOT EXTRACT, ALCOHOL DENAT., BHT, PAEONIA LACTIFLORA ROOT EXTRACT, LILIUM CANDIDUM BULB EXTRACT, HYDROGENATED POLY(C6-14 OLEFIN), POLYGONATUM ODORATUM RHIZOME EXTRACT, CETYL ETHYLHEXANOATE, HYALURONIC ACID, AMINOPROPYL TRIETHOXYSILANE, NELUMBO NUCIFERA FLOWER EXTRACT, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, TOCOPHEROL, CETEARYL ALCOHOL, SODIUM STEAROYL GLUTAMATE, RED 7 (CI 15850), BETA-GLUCAN, PRUNUS MUME FLOWER EXTRACT
37W1	WATER / AQUA / EAU, CYCLOPENTASILOXANE, DIPHENYLSILOXY PHENYL TRIMETHICONE, IRON OXIDES (CI 77492), TITANIUM DIOXIDE (CI 77891), PEG-10 DIMETHICONE, PROPANEDIOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, CYCLOHEXASILOXANE, TRIMETHYLSILOXYSILICATE, NIACINAMIDE, GLYCERIN, CAPRYLYL METHICONE, IRON OXIDES (CI 77491), DISTEARDIMONIUM HECTORITE, MAGNESIUM POTASSIUM FLUOROSILICATE, POLYMETHYL METHACRYLATE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, IRON OXIDES (CI 77499), 1,2-HEXANEDIOL, BUTYLENE GLYCOL, SODIUM CHLORIDE, ALUMINA, SYNTHETIC FLUORPHLOGOPITE, GLYCERYL STEARATE CITRATE, FRAGRANCE / PARFUM, ACRYLATES/DIMETHICONE COPOLYMER, TRIETHOXYCAPRYLYLSILANE, POLYHYDROXYSTEARIC ACID, POLYSORBATE 80, GLYCERYL CAPRYLATE, POLYPHENYLSILSESQUIOXANE, ALUMINUM HYDROXIDE, ISODODECANE, SIMETHICONE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, HYDROGENATED LECITHIN, ETHYLHEXYL PALMITATE, LECITHIN, ISOSTEARIC ACID, ISOPROPYL PALMITATE, SODIUM HYALURONATE, DISODIUM EDTA, ADENOSINE, POLYSILICONE-11, POLYGLYCERYL-3 POLYRICINOLEATE, HONEY / MEL / MIEL, BETAINE, REHMANNIA GLUTINOSA ROOT EXTRACT, ALCOHOL DENAT., BHT, PAEONIA LACTIFLORA ROOT EXTRACT, LILIUM CANDIDUM BULB EXTRACT, HYDROGENATED POLY(C6-14 OLEFIN), POLYGONATUM ODORATUM RHIZOME EXTRACT, CETYL ETHYLHEXANOATE, HYALURONIC ACID, AMINOPROPYL TRIETHOXYSILANE, NELUMBO NUCIFERA FLOWER EXTRACT, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, TOCOPHEROL, CETEARYL ALCOHOL, SODIUM STEAROYL GLUTAMATE, RED 7 (CI 15850), BETA-GLUCAN, PRUNUS MUME FLOWER EXTRACT