Obagi Medical Back To Basics (including Obagi Medical Professional-c Serum 15)
Homosalate, Octisalate, And Zinc Oxide
Obagi Cosmeceuticals Llc
Human Otc Drug
NDC 62032-694Obagi Medical Back To Basics (including Obagi Medical Professional-c Serum 15) 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 Medical Back To Basics (including Obagi Medical Professional-c Serum 15) is 62032-694. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Obagi Medical Back To Basics (including Obagi Medical Professional-c Serum 15) drug includes . The currest status of Obagi Medical Back To Basics (including Obagi Medical Professional-c Serum 15) drug is Active.
Drug Information:
| Drug NDC: | 62032-694 |
| 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 Medical Back To Basics (including Obagi Medical Professional-c Serum 15) |
| 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: | 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: | OTC MONOGRAPH 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: | 01 Apr, 2022 |
| 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. |
| 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: | 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 |
|---|
| 62032-694-02 | 1 BAG in 1 CARTON (62032-694-02) / 1 KIT in 1 BAG * 1 BOTTLE, DROPPER in 1 CARTON / 30 mL in 1 BOTTLE, DROPPER * 1 TUBE in 1 CARTON / 30 mL in 1 TUBE * 28 g in 1 TUBE * 59 mL in 1 BOTTLE, PLASTIC * 60 mL in 1 BOTTLE, PLASTIC | 01 Apr, 2022 | 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 medical back to basics (including obagi medical professional-c serum 15) homosalate, octisalate, and zinc oxide obagi nu-derm foaming .alpha.-amylcinnamaldehyde acetyl hexamethyl tetralin medicago sativa whole aloe vera leaf borago officinalis seed butylparaben butylphenyl methylpropional chamomile cocamidopropyl betaine d&c red no. 33 dihydromyrcenol dioscorea villosa tuber ethylparaben fd&c yellow no. 5 geranyl acetate glycerin hexyl salicylate hydroxyisohexyl 3-cyclohexene carboxaldehyde isobutylparaben isomethyl-.alpha.-ionone limonene, (+)- linalool, (+/-)- methylparaben phenoxyethanol phenylethyl alcohol propylparaben quillaja saponaria bark smilax aristolochiifolia root sodium chloride sodium laureth-3 sulfate sodium lauroyl oat amino acids water xanthan gum yucca schidigera root obagi nu-derm toner .alpha.-amylcinnamaldehyde acetyl hexamethyl tetralin allantoin aloe vera leaf borago officinalis seed butylphenyl methylpropional calendula officinalis flower dihydromyrcenol dioscorea villosa tuber dmdm hydantoin fd&c blue no. 1 geranyl acetate glycerin hamamelis virginiana top water hexyl salicylate hydroxyisohexyl 3-cyclohexene carboxaldehyde iodopropynyl butylcarbamate isomethyl-.alpha.-ionone limonene, (+)- linalool, (+/-)- panthenol phenylethyl alcohol polysorbate 80 potassium alum quillaja saponaria bark sage smilax aristolochiifolia root sodium pyrrolidone carboxylate water yucca schidigera root obagi medical professional-c serum 15 alcohol ascorbic acid ascorbyl glucoside evernia prunastri grapefruit peel octoxynol-9 propylene glycol pseudevernia furfuracea water obagi medical retinol .alpha.-tocopherol acetate allyl methacrylate/glycol dimethacrylate crosspolymer ascorbic acid butylated hydroxytoluene butylene glycol caprylyl glycol carbomer homopolymer, unspecified type chamomile cyclomethicone 5 cyclomethicone 6 dimethicone dimethicone/vinyl dimethicone crosspolymer (soft particle) edetate disodium ethylhexylglycerin glycerin glyceryl monostearate glycyrrhizinate dipotassium hexylene glycol hyaluronate sodium hypericum perforatum flower jojoba oil levomenol malva sylvestris flower medium-chain triglycerides phenoxyethanol polysorbate 20 polysorbate 60 propylene glycol retinol sage sambucus nigra flower shea butter sorbitol stearic acid stearyl alcohol trolamine ubidecarenone water obagi medical sun shield broad spectrum spf 50 matte suncreen homosalate, octisalate, and zinc oxide homosalate homosalate octisalate octisalate zinc oxide zinc oxide 1,2-hexanediol c15-19 alkane candelilla wax caprylyl glycol dimethicone disteardimonium hectorite edetate disodium anhydrous glycerin hydroxyacetophenone octyldodecyl neopentanoate polyglyceryl-2 isostearate polyglyceryl-6 polyricinoleate polyhydroxystearic acid (2300 mw) polymethylsilsesquioxane (4.5 microns) silicon dioxide sodium chloride sodium hydroxide sorbitan olivate triethoxycaprylylsilane water xanthan gum yellow wax
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 back to basics obagi ® medical principal display panel - kit carton
Further Questions:
Questions or comments? 1.800.636.7546 mondayâfriday 9 a.m.â4 p.m. pst