Mary Kay Timewise Miracle Set 3d Sampler (combo To Oily Skin)
Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone
Mary Kay Inc.
Human Otc Drug
NDC 51531-5607Mary Kay Timewise Miracle Set 3d Sampler (combo To Oily Skin) also known as Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone is a human otc drug labeled by 'Mary Kay Inc.'. National Drug Code (NDC) number for Mary Kay Timewise Miracle Set 3d Sampler (combo To Oily Skin) is 51531-5607. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Mary Kay Timewise Miracle Set 3d Sampler (combo To Oily Skin) drug includes . The currest status of Mary Kay Timewise Miracle Set 3d Sampler (combo To Oily Skin) drug is Active.
Drug Information:
| Drug NDC: | 51531-5607 |
| 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: | Mary Kay Timewise Miracle Set 3d Sampler (combo To Oily Skin) |
| 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, Homosalate, Octisalate, Octocrylene, And Oxybenzone |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Mary Kay 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: | 16 May, 2018 |
| 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: | M020 |
| 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: | Mary Kay 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: | |
| 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 |
|---|
| 51531-5607-0 | 1 KIT in 1 CARTON (51531-5607-0) * 3 g in 1 PACKET * 1.7 g in 1 TUBE * .5 g in 1 TUBE * 1.7 g in 1 PACKET | 16 May, 2018 | N/A | Yes |
| 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:
Mary kay timewise miracle set 3d sampler (combo to oily skin) avobenzone, homosalate, octisalate, octocrylene, and oxybenzone timewise age minimize 3d day cream spf 30 broad spectrum sunscreen (combo to oily skin) avobenzone, homosalate, octisalate, octocrylene, oxybenzone water glycerin dicaprylyl carbonate dimethicone ammonium acryloyldimethyltaurate/vp copolymer cetostearyl alcohol ceteareth-25 niacinamide prickly pear fruit saccharomyces cerevisiae .alpha.-tocopherol acetate resveratrol sucrose palmitate levomenol silicon dioxide disodium ethylene dicocamide peg-15 disulfate hydroxypropyl .alpha.-cyclodextrin glyceryl monolinoleate diethylene glycol monoethyl ether methyl dihydrojasmonate (synthetic) ethylene brassylate tetramethyl acetyloctahydronaphthalenes ethyl linalool 2-isobutyl-4-methyltetrahydropyran-4-ol 3-(3,4-methylenedioxyphenyl)-2-methylpropanal phenylisohexanol trimethylbenzenepropanol methyl benzodioxepinone trolamine sodium benzoate edetate disodium caprylhydroxamic acid phenoxyethanol ethylhexylglycerin propanediol caprylyl glycol iodopropynyl butylcarbamate avobenzone avobenzone homosalate homosalate octisalate octisalate octocrylene octocrylene oxybenzone oxybenzone timewise age minimize 3d 4-in-1 cleanser (combo to oily skin) water triethanolamine lauryl sulfate butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw) propanediol cocamidopropyl betaine trolamine ppg-2 hydroxyethyl coco/isostearamide carnauba wax niacinamide glycerin resveratrol powdered cellulose lactose, unspecified form hypromellose, unspecified hydroxypropyl .alpha.-cyclodextrin citric acid monohydrate sodium chloride methyl dihydrojasmonate (synthetic) ethylene brassylate ethyl linalool tetramethyl acetyloctahydronaphthalenes 2-isobutyl-4-methyltetrahydropyran-4-ol 3-(3,4-methylenedioxyphenyl)-2-methylpropanal phenylisohexanol trimethylbenzenepropanol methyl benzodioxepinone edetate disodium iodopropynyl butylcarbamate magnesium chloride magnesium nitrate methylisothiazolinone methylchloroisothiazolinone talc d&c red no. 30 ultramarine blue timewise age minimize 3d night cream (combo to oily skin) water glycerin isohexadecane butylene glycol aluminum starch octenylsuccinate isocetyl stearate cetyl alcohol cetyl esters wax caprylyl trisiloxane niacinamide cetostearyl alcohol glyceryl monostearate resveratrol arachidyl glucoside sodium acryloyldimethyltaurate-acrylamide copolymer (1:1; 90000-150000 mpa.s) medium-chain triglycerides stearic acid .alpha.-tocopherol acetate panthenol sucrose palmitate peg-100 stearate arachidyl alcohol carbomer copolymer type a (allyl pentaerythritol crosslinked) dimethicone docosanol xanthan gum polysorbate 80 hydroxypropyl .alpha.-cyclodextrin glyceryl monolinoleate diethylene glycol monoethyl ether methyl dihydrojasmonate (synthetic) ethylene brassylate tetramethyl acetyloctahydronaphthalenes ethyl linalool 2-isobutyl-4-methyltetrahydropyran-4-ol 3-(3,4-methylenedioxyphenyl)-2-methylpropanal phenylisohexanol trimethylbenzenepropanol methyl benzodioxepinone trolamine edetate disodium phenoxyethanol 1,2-hexanediol hydroxyacetophenone caprylyl glycol iodopropynyl butylcarbamate titanium dioxide steareth-10 steareth-20 timewise age minimize 3d eye cream water cetyl alcohol glycerin alkyl (c12-15) benzoate stearic acid glyceryl monostearate peg-100 stearate 1,2-hexanediol niacinamide fucus vesiculosus panthenol resveratrol .alpha.-tocopherol acetate glycyrrhizinate dipotassium xanthan gum hexylene glycol dimethicone poly(methyl methacrylate; 450000 mw) tricaprylin ethylhexyl palmitate silicon dioxide hydroxypropyl .alpha.-cyclodextrin trolamine edetate disodium benzyl alcohol caprylyl glycol iodopropynyl butylcarbamate mica titanium 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 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 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 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 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 - combo/oily sample packettes mary kay timewise age minimize 3d 4-in-1 cleanser .1 oz. net wt. / 3 g mary kay timewise age minimize 3d day cream spf 30 broad-spectrum sunscreen .06 oz. net wt. / 1.7 g / 1,7 g mary kay timewise age minimize 3d night cream .06 oz. net wt. / 1.7 g / 1,7 g mary kay timewise age minimize 3d eye cream .01 oz. net wt. / 0.5 g / 0,5 g image of sample packettes
Further Questions:
Questions? call toll-free 1-800-627-9529