Sulwhasoo Perfecting Cushion No. 21
Octinoxate, Titanium Dioxide, And Zinc Oxide
Amorepacific Corporation
Human Otc Drug
NDC 43419-077Sulwhasoo Perfecting Cushion No. 21 also known as Octinoxate, Titanium Dioxide, And Zinc Oxide is a human otc drug labeled by 'Amorepacific Corporation'. National Drug Code (NDC) number for Sulwhasoo Perfecting Cushion No. 21 is 43419-077. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Sulwhasoo Perfecting Cushion No. 21 drug includes Octinoxate - 2.1 g/30g Titanium Dioxide - 1.245 g/30g Zinc Oxide - 2.94 g/30g . The currest status of Sulwhasoo Perfecting Cushion No. 21 drug is Active.
Drug Information:
| Drug NDC: | 43419-077 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Sulwhasoo Perfecting Cushion No. 21 |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Octinoxate, Titanium Dioxide, And Zinc Oxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Amorepacific Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | OCTINOXATE - 2.1 g/30g
TITANIUM DIOXIDE - 1.245 g/30g
ZINC OXIDE - 2.94 g/30g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 15 Jul, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part352 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Amorepacific Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 4Y5P7MUD51
15FIX9V2JP
SOI2LOH54Z
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 43419-077-31 | 2 CONTAINER in 1 CARTON (43419-077-31) / 15 g in 1 CONTAINER | 15 Jul, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose sunscreen
Product Elements:
Sulwhasoo perfecting cushion no. 21 octinoxate, titanium dioxide, and zinc oxide 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 octinoxate octinoxate titanium dioxide titanium dioxide zinc oxide zinc oxide sulwhasoo perfecting cushion no. 27 octinoxate, titanium dioxide, and zinc oxide 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 octinoxate octinoxate titanium dioxide titanium dioxide zinc oxide zinc oxide sulwhasoo perfecting cushion no. 31 octinoxate, titanium dioxide, and zinc oxide 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 octinoxate octinoxate titanium dioxide titanium dioxide zinc oxide zinc oxide sulwhasoo perfecting cushion no. 33 octinoxate, titanium dioxide, and zinc oxide 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 octinoxate octinoxate titanium dioxide titanium dioxide zinc oxide zinc oxide sulwhasoo perfecting cushion no. 15 octinoxate, titanium dioxide, and zinc oxide 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 octinoxate octinoxate titanium dioxide titanium dioxide zinc oxide zinc oxide sulwhasoo perfecting cushion no. 17 octinoxate, titanium dioxide, and zinc oxide 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 octinoxate octinoxate titanium dioxide titanium dioxide zinc oxide zinc oxide sulwhasoo perfecting cushion no. 23 octinoxate, titanium dioxide, and zinc oxide 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 octinoxate octinoxate titanium dioxide titanium dioxide zinc oxide zinc oxide sulwhasoo perfecting cushion no. 37 octinoxate, titanium dioxide, and zinc oxide 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 octinoxate octinoxate titanium dioxide titanium dioxide zinc oxide zinc oxide sulwhasoo perfecting cushion no. 11 octinoxate, titanium dioxide, and zinc oxide 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 octinoxate octinoxate titanium dioxide titanium dioxide zinc oxide zinc oxide sulwhasoo perfecting cushion no. 25 octinoxate, titanium dioxide, and zinc oxide 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 octinoxate octinoxate titanium dioxide titanium dioxide zinc oxide zinc oxide
Indications and Usage:
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:
Warnings for external use only do not use on broken skin. when using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water. stop use and ask a doctor if rash occurs. keep out of reach of children. if swallowed, call a poison control centre or get medical help right away.
Do Not Use:
Warnings for external use only do not use on broken skin. when using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water. stop use and ask a doctor if rash occurs. keep out of reach of children. if swallowed, call a poison control centre or get medical help right away.
When Using:
When using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water.
Dosage and Administration:
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.
Stop Use:
Stop use and ask a doctor if rash occurs.
Package Label Principal Display Panel:
Principal display panel - no. 11 porcelain(pink) sulwhasoo perfecting cushion broad spectrum 50+ sunscreen no. 11 porcelain(pink) 30 g(15 g x 2) / net wt. 1.05 oz. no. 11 p inner
Principal display panel - no. 15 ivory(pink) sulwhasoo perfecting cushion broad spectrum 50+ sunscreen no. 15 ivory(pink) 30 g(15 g x 2) / net wt. 1.05 oz. no. 15 p inner
Principal display panel - no. 17 ivory(beige) sulwhasoo perfecting cushion broad spectrum spf50+ sunscreen no. 17 ivory(beige) 30 g(15 g x 2) / net wt. 1.05 oz. no.17 p inner
Principal display panel - no. 21 natural(pink) sulwhasoo perfecting cushion broad spectrum 50+ sunscreen no. 21 natural(pink) 30 g(15 g x 2) / net wt. 1.05 oz. no. 21 p inner sulwhasoo perfecting cushion no. 21 natural (pink) spring limited edition sulwhasoo perfecting cushion broad spectrum spf 50+ sunscreen no. 21 natural (pink) 30g (15g x 2) / net wt. 1.05 oz. 21
Sulwhasoo perfecting cushion no. 21 natural (pink) spring limited edition sulwhasoo perfecting cushion broad spectrum spf 50+ sunscreen no. 21 natural (pink) 30g (15g x 2) / net wt. 1.05 oz. 21
Principal display panel - no. 23 natural(beige) sulwhasoo perfecting cushion broad spectrum 50+ sunscreen no. 23 natural(beige) 30 g(15 g x 2) / net wt. 1.05 oz. no. 23 p inner sulwhasoo perfecting cushion no. 23 natural (beige) spring limited edition sulwhasoo perfecting cushion broad spectrum spf 50+ sunscreen no. 23 natural (beige) 30g (15g x 2) / net wt. 1.05 oz. 23
Sulwhasoo perfecting cushion no. 23 natural (beige) spring limited edition sulwhasoo perfecting cushion broad spectrum spf 50+ sunscreen no. 23 natural (beige) 30g (15g x 2) / net wt. 1.05 oz. 23
Principal display panel - no. 25 sand(pink) sulwhasoo perfecting cushion broad spectrum spf50+ sunscreen no. 25 sand(pink) 30 g(15 g x 2) / net wt. 1.05 oz. no. 25 p in sulwhasoo perfecting cushion no. 25 sand (pink) spring limited edition sulwhasoo perfecting cushion broad spectrum spf 50+ sunscreen no. 25 sand (pink) 30g (15g x 2) / net wt. 1.05 oz. 25
Sulwhasoo perfecting cushion no. 25 sand (pink) spring limited edition sulwhasoo perfecting cushion broad spectrum spf 50+ sunscreen no. 25 sand (pink) 30g (15g x 2) / net wt. 1.05 oz. 25
Principal display panel - no. 27 sand(beige) sulwhasoo perfecting cushion broad spectrum 50+ sunscreen no. 27 sand(beige) 30 g(15 g x 2) / net wt. 1.05 oz. no. 27 p in
âprincipal 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 p in
âprincipal 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 p in
âprincipal 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 p in