Obagi 360
Avobenzone, Octinoxate, Octisalate, Oxybenzone
Omp, Inc.
Human Otc Drug
NDC 62032-580Obagi 360 also known as Avobenzone, Octinoxate, Octisalate, Oxybenzone is a human otc drug labeled by 'Omp, Inc.'. National Drug Code (NDC) number for Obagi 360 is 62032-580. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Obagi 360 drug includes . The currest status of Obagi 360 drug is Active.
Drug Information:
| Drug NDC: | 62032-580 |
| 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 360 |
| 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: | Avobenzone, Octinoxate, Octisalate, Oxybenzone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Omp, Inc. |
| 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: | 08 Sep, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 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: | OMP, Inc.
|
| 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. |
| UPC: | 0362032580883
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 62032-580-88 | 1 KIT in 1 CARTON (62032-580-88) * 150 mL in 1 TUBE * 28 g in 1 TUBE * 75 g in 1 TUBE | 08 Sep, 2015 | 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:
Obagi 360 avobenzone, octinoxate, octisalate, oxybenzone obagi hydrafactor broad spectrum spf 30 sunscreen avobenzone avobenzone octinoxate octinoxate octisalate octisalate oxybenzone oxybenzone carbomer copolymer type a (allyl pentaerythritol crosslinked) butyloctyl salicylate alkyl (c12-15) benzoate caesalpinia spinosa resin caprylyl glycol carbomer homopolymer type c (allyl pentaerythritol crosslinked) icodextrin edetate disodium eperua falcata bark ethylhexylglycerin glycerin hexylene glycol phenoxyethanol polysorbate 20 hyaluronate sodium sodium hydroxide sorbitan monooleate .alpha.-tocopherol acetate ubidecarenone water obagi retinol 0.5 retinol cream water medium-chain triglycerides cyclomethicone 5 butylene glycol stearic acid shea butter polysorbate 60 stearyl alcohol glycerin retinol polysorbate 20 dimethicone safflower oil calendula officinalis flower camellia oleifera leaf green tea leaf chamomile .alpha.-tocopherol acetate ascorbic acid hyaluronate sodium cyclomethicone 6 sorbitol butylated hydroxytoluene glycyrrhizinate dipotassium edetate disodium caprylyl glycol ethylhexylglycerin hexylene glycol phenoxyethanol obagi exfoliating cleanser cleanser water decyl glucoside glycerin sodium cocoyl isethionate cocamidopropyl betaine sodium lauroamphoacetate sodium methyl cocoyl taurate carbomer interpolymer type a (allyl sucrose crosslinked) phenoxyethanol caprylyl glycol sodium pyrrolidone carboxylate panthenol sodium hydroxide chlorphenesin ethylhexylglycerin hexylene glycol edetate disodium hyaluronate sodium papain 1,2-hexanediol
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 avoid getting into eyes. for external use only. keep out of reach of children.
Warnings when using this product, you may experience mild redness, peeling, or skin irritation. these are normal, temporary indications the product is working. if irritation occurs, limit use to every other night, or as tolerated. when skin has adjusted, revert to daily use. do not use if you are pregnant, lactating, planning to become pregnant, taking prescription acne medication, have compromised skin such as flaring dermatitis, or are undergoing skin peeling treatments. daily use of a broad spectrum sunscreen with an spf of 30 or higher is highly recommended. avoid getting into eyes. if contact occurs, rinse thoroughly with water. for external use only. keep out of reach of children.
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.
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 children under 6 months: ask a doctor 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
Package Label Principal Display Panel:
Principal display panel - kit carton obagi 360 exfoliating cleanser hydrafactor spf 30 retinol 0.5 obagi® medical obagi 360 - kit carton
Further Questions:
Questions or comments? 1.800.636.7546 mondayfriday 9 a.m.4 p.m. pacific time