Dynamic Skin Recovery Spf 50
Avobenzone And Octinoxate
Dermalogica, Inc.
Human Otc Drug
NDC 68479-318Dynamic Skin Recovery Spf 50 also known as Avobenzone And Octinoxate is a human otc drug labeled by 'Dermalogica, Inc.'. National Drug Code (NDC) number for Dynamic Skin Recovery Spf 50 is 68479-318. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Dynamic Skin Recovery Spf 50 drug includes Avobenzone - 30 mg/mL Octinoxate - 75 mg/mL . The currest status of Dynamic Skin Recovery Spf 50 drug is Active.
Drug Information:
| Drug NDC: | 68479-318 |
| 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: | Dynamic Skin Recovery Spf 50 |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Dynamic Skin Recovery |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | SPF 50 |
| 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: | Avobenzone And Octinoxate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dermalogica, Inc. |
| 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: | AVOBENZONE - 30 mg/mL
OCTINOXATE - 75 mg/mL
|
| 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 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: | 09 Dec, 2013 |
| 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: | Dermalogica, 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. |
| UNII: | G63QQF2NOX
4Y5P7MUD51
|
| 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 |
|---|
| 68479-318-00 | 2 mL in 1 POUCH (68479-318-00) | 09 Dec, 2013 | N/A | No |
| 68479-318-01 | 1 BOTTLE in 1 CARTON (68479-318-01) / 12 mL in 1 BOTTLE | 09 Dec, 2013 | N/A | No |
| 68479-318-02 | 1 BOTTLE in 1 CARTON (68479-318-02) / 50 mL in 1 BOTTLE | 09 Dec, 2013 | N/A | No |
| 68479-318-03 | 1 BOTTLE in 1 CARTON (68479-318-03) / 100 mL in 1 BOTTLE | 09 Dec, 2013 | N/A | No |
| 68479-318-04 | 118 mL in 1 BOTTLE (68479-318-04) | 09 Dec, 2013 | 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:
Dynamic skin recovery spf 50 avobenzone and octinoxate avobenzone avobenzone octinoxate octinoxate water butylene glycol carthamus tinctorius seed oleosomes alkyl (c12-15) benzoate cyclomethicone 5 glycerin green tea leaf dimethicone dimethyl capramide phenoxyethanol polysorbate 80 hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%) cetostearyl alcohol squalane dimethicone/vinyl dimethicone crosspolymer (soft particle) lecithin, soybean titanium dioxide galactoarabinan sunflower oil stearic acid edetate disodium anhydrous gluconic acid glycyrrhizinate dipotassium ethylhexylglycerin polysorbate 60 aminomethylpropanol rosewood oil polyoxyl 20 cetostearyl ether 1,2-hexanediol 1-dehydro-7.alpha.-methyltestosterone sodium benzoate clove oil urea glucosamine hydrochloride lemon oil, cold pressed pelargonium graveolens flower oil laminaria digitata saccharomyces cerevisiae rosa x alba flower oil palmitoyl tripeptide-5 tocopherol decyl glucoside butylated hydroxytoluene medium-chain triglycerides lemon peel hyaluronate sodium cupressus sempervirens leaf oil palmarosa oil methylparaben cymbopogon schoenanthus oil eucalyptus oil rosa x damascena flower oil soy protein linalool, (+/-)- eugenol limonene, (+)- .beta.-citronellol, (r)- geraniol
Indications and Usage:
Uses helps prevent sunburn. if used as directed with other sun protection measures (see directions ), helps decrease 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 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 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 30 minutes before sun exposure reapply at least every two 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 help decrease this risk, regularly use a sunscreen with a broad spectrum spf 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-sleeve shirts, pants, hats and sunglasses do not use on infants under 6 months old.
Stop Use:
Stop use and ask a doctor if rash occurs.
Package Label Principal Display Panel:
Principal display panel - 12 ml bottle carton hydrating, firming age defense dynamic skin recovery spf 50 high protection uva uvb broad spectrum dermalogica skin care by the international dermal institute age smart 0.4 us fl oz / 12 ml e principal display panel - 12 ml bottle carton
Further Questions:
Questions or comments call toll free 1-800-831-5150 in the us.