Sulwhasoo Perpecting Cushion Brightening No.21 Medium Pink
Octinoxate, Titanium Dioxide, And Zinc Oxide
Amorepacific Corporation
Human Otc Drug
NDC 43419-057Sulwhasoo Perpecting Cushion Brightening No.21 Medium Pink 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 Perpecting Cushion Brightening No.21 Medium Pink is 43419-057. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Sulwhasoo Perpecting Cushion Brightening No.21 Medium Pink drug includes Octinoxate - 2.1 g/30g Titanium Dioxide - 1.245 g/30g Zinc Oxide - 2.94 g/30g . The currest status of Sulwhasoo Perpecting Cushion Brightening No.21 Medium Pink drug is Active.
Drug Information:
| Drug NDC: | 43419-057 |
| 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 Perpecting Cushion Brightening No.21 Medium Pink |
| 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: | 11 Apr, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Jun, 2026 |
| 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 |
|---|
| 43419-057-36 | 2 CARTON in 1 CARTON (43419-057-36) / 2 CONTAINER in 1 CARTON / 15 g in 1 CONTAINER | 23 Jul, 2018 | 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 perpecting cushion brightening no.11 pale pink octinoxate, titanium dioxide, and zinc oxide glycyrrhiza uralensis phenyl trimethicone cyclomethicone 5 butylene glycol butylene glycol dicaprylate/dicaprate cyclomethicone 6 lauryl peg-9 polydimethylsiloxyethyl dimethicone arbutin water dimethicone sorbitan isostearate sodium chloride aluminum hydroxide mica ferric oxide yellow phenoxyethanol dimethicone/vinyl dimethicone crosspolymer (soft particle) poly(methyl methacrylate; 450000 mw) stearic acid disteardimonium hectorite triethoxycaprylylsilane hexamethylene diisocyanate/trimethylol hexyllactone crosspolymer glycerin caprylyl glycol ferric oxide red ethylhexylglycerin alcohol edetate disodium adenosine ferrosoferric oxide hyaluronate sodium silicon dioxide propanediol 1,2-hexanediol polygonatum odoratum root rehmannia glutinosa root lilium lancifolium flowering top paeonia lactiflora root nelumbo nucifera seed asian ginseng honey magnolia biondii flower octinoxate octinoxate titanium dioxide titanium dioxide zinc oxide zinc oxide sulwhasoo perpecting cushion brightening no.13 light pink octinoxate, titanium dioxide, and zinc oxide glycyrrhiza uralensis phenyl trimethicone cyclomethicone 5 butylene glycol butylene glycol dicaprylate/dicaprate cyclomethicone 6 lauryl peg-9 polydimethylsiloxyethyl dimethicone arbutin water dimethicone sorbitan isostearate sodium chloride poly(methyl methacrylate; 450000 mw) aluminum hydroxide mica ferric oxide yellow phenoxyethanol dimethicone/vinyl dimethicone crosspolymer (soft particle) stearic acid disteardimonium hectorite hexamethylene diisocyanate/trimethylol hexyllactone crosspolymer triethoxycaprylylsilane glycerin caprylyl glycol ferric oxide red ethylhexylglycerin alcohol edetate disodium adenosine ferrosoferric oxide hyaluronate sodium silicon dioxide propanediol 1,2-hexanediol polygonatum odoratum root rehmannia glutinosa root lilium lancifolium flowering top paeonia lactiflora root nelumbo nucifera seed asian ginseng honey magnolia biondii flower octinoxate octinoxate titanium dioxide titanium dioxide zinc oxide zinc oxide sulwhasoo perpecting cushion brightening no.17 light beige octinoxate, titanium dioxide, and zinc oxide glycyrrhiza uralensis phenyl trimethicone cyclomethicone 5 butylene glycol butylene glycol dicaprylate/dicaprate cyclomethicone 6 lauryl peg-9 polydimethylsiloxyethyl dimethicone arbutin water dimethicone sorbitan isostearate sodium chloride ferric oxide yellow poly(methyl methacrylate; 450000 mw) aluminum hydroxide mica phenoxyethanol dimethicone/vinyl dimethicone crosspolymer (soft particle) stearic acid disteardimonium hectorite hexamethylene diisocyanate/trimethylol hexyllactone crosspolymer triethoxycaprylylsilane glycerin caprylyl glycol ferric oxide red ethylhexylglycerin alcohol edetate disodium ferrosoferric oxide adenosine hyaluronate sodium silicon dioxide propanediol 1,2-hexanediol polygonatum odoratum root rehmannia glutinosa root lilium lancifolium flowering top paeonia lactiflora root nelumbo nucifera seed asian ginseng honey magnolia biondii flower octinoxate octinoxate titanium dioxide titanium dioxide zinc oxide zinc oxide sulwhasoo perpecting cushion brightening no.21 medium pink octinoxate, titanium dioxide, and zinc oxide glycyrrhiza uralensis phenyl trimethicone cyclomethicone 5 butylene glycol butylene glycol dicaprylate/dicaprate cyclomethicone 6 lauryl peg-9 polydimethylsiloxyethyl dimethicone arbutin water dimethicone sorbitan isostearate sodium chloride ferric oxide yellow poly(methyl methacrylate; 450000 mw) aluminum hydroxide mica phenoxyethanol dimethicone/vinyl dimethicone crosspolymer (soft particle) stearic acid disteardimonium hectorite hexamethylene diisocyanate/trimethylol hexyllactone crosspolymer triethoxycaprylylsilane glycerin caprylyl glycol ferric oxide red ethylhexylglycerin alcohol edetate disodium adenosine ferrosoferric oxide hyaluronate sodium silicon dioxide propanediol 1,2-hexanediol polygonatum odoratum root rehmannia glutinosa root lilium lancifolium flowering top paeonia lactiflora root nelumbo nucifera seed asian ginseng honey magnolia biondii flower octinoxate octinoxate titanium dioxide titanium dioxide zinc oxide zinc oxide sulwhasoo perpecting cushion brightening no.23 medium beige octinoxate, titanium dioxide, and zinc oxide glycyrrhiza uralensis phenyl trimethicone cyclomethicone 5 butylene glycol butylene glycol dicaprylate/dicaprate cyclomethicone 6 lauryl peg-9 polydimethylsiloxyethyl dimethicone arbutin water dimethicone sorbitan isostearate sodium chloride ferric oxide yellow aluminum hydroxide mica phenoxyethanol dimethicone/vinyl dimethicone crosspolymer (soft particle) stearic acid poly(methyl methacrylate; 450000 mw) disteardimonium hectorite triethoxycaprylylsilane hexamethylene diisocyanate/trimethylol hexyllactone crosspolymer glycerin caprylyl glycol ferric oxide red ethylhexylglycerin ferrosoferric oxide alcohol edetate disodium adenosine hyaluronate sodium silicon dioxide propanediol 1,2-hexanediol polygonatum odoratum root rehmannia glutinosa root lilium lancifolium flowering top paeonia lactiflora root nelumbo nucifera seed asian ginseng honey magnolia biondii flower octinoxate octinoxate titanium dioxide titanium dioxide zinc oxide zinc oxide sulwhasoo perpecting cushion brightening no.25 deep beige octinoxate, titanium dioxide, and zinc oxide hyaluronate sodium silicon dioxide propanediol 1,2-hexanediol polygonatum odoratum root rehmannia glutinosa root lilium lancifolium flowering top paeonia lactiflora root nelumbo nucifera seed asian ginseng honey magnolia biondii flower octinoxate octinoxate titanium dioxide titanium dioxide zinc oxide zinc oxide glycyrrhiza uralensis phenyl trimethicone cyclomethicone 5 butylene glycol butylene glycol dicaprylate/dicaprate cyclomethicone 6 lauryl peg-9 polydimethylsiloxyethyl dimethicone arbutin water dimethicone ferric oxide yellow sorbitan isostearate sodium chloride aluminum hydroxide mica phenoxyethanol dimethicone/vinyl dimethicone crosspolymer (soft particle) stearic acid triethoxycaprylylsilane disteardimonium hectorite hexamethylene diisocyanate/trimethylol hexyllactone crosspolymer ferric oxide red glycerin caprylyl glycol poly(methyl methacrylate; 450000 mw) ethylhexylglycerin ferrosoferric oxide alcohol edetate disodium adenosine sulwhasoo perpecting cushion brightening no.33 dark beige octinoxate, titanium dioxide, and zinc oxide glycyrrhiza uralensis phenyl trimethicone cyclomethicone 5 butylene glycol butylene glycol dicaprylate/dicaprate cyclomethicone 6 lauryl peg-9 polydimethylsiloxyethyl dimethicone arbutin water dimethicone sorbitan isostearate sodium chloride poly(methyl methacrylate; 450000 mw) mica aluminum hydroxide phenoxyethanol dimethicone/vinyl dimethicone crosspolymer (soft particle) stearic acid ferric oxide red disteardimonium hectorite hexamethylene diisocyanate/trimethylol hexyllactone crosspolymer triethoxycaprylylsilane glycerin caprylyl glycol ferrosoferric oxide ethylhexylglycerin alcohol edetate disodium ferric oxide yellow adenosine hyaluronate sodium silicon dioxide propanediol 1,2-hexanediol polygonatum odoratum root rehmannia glutinosa root lilium lancifolium flowering top paeonia lactiflora root nelumbo nucifera seed asian ginseng honey magnolia biondii flower 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 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.
Do Not Use:
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.
When Using:
When using this product keep out of eyes. rinse with water to remove.
Dosage and Administration:
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.
Stop Use:
Stop use and ask a doctor if rash occurs.
Package Label Principal Display Panel:
Principal display panel - 30 g container carton - no. 11 pale pink sulwhasoo perfecting cushion brightening broad spectrum spf50+ sunscreen no. 11 pale pink 30 g(15 g x 2) / net wt. 1.05 oz. din 02464772 principal display panel - 30 g container carton - no. 11 pale pink
Principal display panel - 30 g container carton - no. 13 light pink sulwhasoo perfecting cushion brightening broad spectrum spf50+ sunscreen no. 13 light pink 30 g(15 g x 2) / net wt. 1.05 oz. din 02464772 principal display panel - 30 g container carton - no. 13 light pink
Principal display panel - 30 g container carton - no. 17 light beige sulwhasoo perfecting cushion brightening broad spectrum spf50+ sunscreen no. 17 light beige 30 g(15 g x 2) / net wt. 1.05 oz. din 02464772 principal display panel - 30 g container carton - no. 17 light beige
Principal display panel - 30 g container carton - no. 21 medium pink sulwhasoo perfecting cushion brightening broad spectrum spf50+ sunscreen no. 21 medium pink 30 g(15 g x 2) / net wt. 1.05 oz. din 02464772 principal display panel - 30 g container carton - no. 21 medium pink
Principal display panel - 30 g container carton - no. 23 medium beige sulwhasoo perfecting cushion brightening broad spectrum spf50+ sunscreen no. 23 medium beige 30 g(15 g x 2) / net wt. 1.05 oz. din 02464772 principal display panel - 30 g container carton - no. 23 medium beige
Principal display panel - 30 g container carton - no. 25 deep beige sulwhasoo perfecting cushion brightening broad spectrum spf50+ sunscreen no. 25 deep beige 30 g(15 g x 2) / net wt. 1.05 oz. din 02464772 principal display panel - 30 g container carton - no. 25 deep beige
Principal display panel - 30 g container carton - no. 33 dark beige sulwhasoo perfecting cushion brightening broad spectrum spf50+ sunscreen no. 33 dark beige 30 g(15 g x 2) / net wt. 1.05 oz. din 02464772 principal display panel - 30 g container carton - no. 33 dark beige
Further Questions:
Questions? for us customers support@us.amorepacific.com for canada customers support@ca.amorepacific.com