Obagi Nu-derm Fx System Normal - Dry Skin Transformation Complexion Brightening System
Homosalate, Octisalate, And Zinc Oxide
Obagi Cosmeceuticals Llc
Human Otc Drug
NDC 62032-539Obagi Nu-derm Fx System Normal - Dry Skin Transformation Complexion Brightening System also known as Homosalate, Octisalate, And Zinc Oxide is a human otc drug labeled by 'Obagi Cosmeceuticals Llc'. National Drug Code (NDC) number for Obagi Nu-derm Fx System Normal - Dry Skin Transformation Complexion Brightening System is 62032-539. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Obagi Nu-derm Fx System Normal - Dry Skin Transformation Complexion Brightening System drug includes . The currest status of Obagi Nu-derm Fx System Normal - Dry Skin Transformation Complexion Brightening System drug is Active.
Drug Information:
| Drug NDC: | 62032-539 |
| 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: | Obagi Nu-derm Fx System Normal - Dry Skin Transformation Complexion Brightening System |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Obagi Nu-derm Fx System Normal - Dry |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Skin Transformation Complexion Brightening System |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Homosalate, Octisalate, And Zinc Oxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Obagi Cosmeceuticals Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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: | UNAPPROVED DRUG OTHER |
| 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: | 02 Dec, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 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. |
| Listing Expiration Date: | 31 Dec, 2024 |
| 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: | Obagi Cosmeceuticals LLC
|
| 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: | |
| 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 |
|---|
| 62032-539-07 | 1 KIT in 1 CARTON (62032-539-07) * 48 g in 1 BOTTLE, PLASTIC * 85 g in 1 TUBE * 57 g in 1 BOTTLE, PLASTIC * 198 mL in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC * 198 mL in 1 BOTTLE, PLASTIC | 02 Dec, 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:
Active ingredients purpose homosalate 10% sunscreen octisalate 5% sunscreen zinc oxide 16.5% sunscreen
Product Elements:
Obagi nu-derm fx system normal - dry skin transformation complexion brightening system homosalate, octisalate, and zinc oxide nu-derm gentle cleanser water glycerin phenoxyethanol methylparaben propylparaben butylparaben ethylparaben isobutylparaben carbomer interpolymer type a (allyl sucrose crosslinked) sodium lauroyl oat amino acids cocamidopropyl betaine sodium laureth-3 sulfate aloe vera leaf glycereth-7 panthenol diethylene glycol monoethyl ether trolamine sage fd&c yellow no. 5 apricot kernel oil oleyl lactate borago officinalis seed nu-derm toner water glycerin hamamelis virginiana top water sodium pyrrolidone carboxylate dmdm hydantoin iodopropynyl butylcarbamate potassium alum panthenol sage calendula officinalis flower polysorbate 80 allantoin aloe vera leaf fd&c blue no. 1 borago officinalis seed nu-derm clear fx skin brightening water arbutin cetyl alcohol glycerin sodium lauryl sulfate stearyl alcohol .alpha.-tocopherol acetate ascorbic acid sodium metabisulfite butylated hydroxytoluene lactic acid, unspecified form edetate disodium anhydrous butylparaben methylparaben propylparaben nu-derm exfoderm skin smoothing water glycerin methylparaben propylparaben polysorbate 60 cetostearyl alcohol steareth-20 canola oil isohexadecane magnesium aluminum silicate cetyl alcohol fytic acid glyceryl monostearate peg-100 stearate dimethicone peg-150 stearate phenoxyethanol butylparaben ethylparaben isobutylparaben potassium cetyl phosphate xanthan gum .alpha.-tocopherol acetate glycereth-7 diethylene glycol monoethyl ether bis-diglyceryl polyacyladipate-2 sodium hydroxide nu-derm hydrate facial moisturizer water glycerin medium-chain triglycerides sodium hydroxide caesalpinia spinosa resin shea butter dimethicone/vinyl dimethicone crosspolymer (soft particle) cyclomethicone 5 cetyl alcohol saccharide isomerate dimethicone tocopherol laureth-12 phenoxyethanol ethylhexylglycerin stearic acid avocado oil soy sterol caprylyl glycol levomenol hexylene glycol tetrahydrodiferuloylmethane panthenol mangifera indica seed butter sodium stearoyl glutamate carbomer homopolymer, unspecified type allantoin glyceryl monostearate nu-derm blend fx skin brightener and blending water glycerin cetyl alcohol arbutin ppg-2 myristyl ether propionate sodium lauryl sulfate trolamine salicylate .alpha.-tocopherol acetate ascorbic acid lactic acid, unspecified form phenyl trimethicone sodium metabisulfite butylated hydroxytoluene edetate disodium anhydrous methylparaben propylparaben nu-derm sun shield broad spectrum spf 50 matte sunscreen homosalate, octisalate, and zinc oxide homosalate homosalate octisalate octisalate zinc oxide zinc oxide water glycerin hydroxyacetophenone xanthan gum sodium chloride sodium hydroxide octyldodecyl neopentanoate triethoxycaprylylsilane c15-19 alkane disteardimonium hectorite polyglyceryl-2 isostearate sorbitan olivate dimethicone 1,2-hexanediol caprylyl glycol edetate disodium candelilla wax yellow wax polymethylsilsesquioxane (4.5 microns) silicon dioxide
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 stop use and ask a doctor if rash occurs when using this product keep out of eyes. rinse with water to remove. keep out of reach of children. if 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 stop use and ask a doctor if rash occurs when using this product keep out of eyes. rinse with water to remove. keep out of reach of children. if 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 use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours 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.â2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months: ask a doctor
Stop Use:
Stop use and ask a doctor if rash occurs
Package Label Principal Display Panel:
Principal display panel - kit carton obagi ® medical obagi nu-derm fx⢠system normal dry skin transformation kit complexion brightening system principal display panel - kit carton
Further Questions:
Questions or comments? 1.800.636.7546 mondayâfriday 9 a.m.â4 p.m. pacific time