NDC 51531-5607 Mary Kay Timewise Miracle Set 3d Sampler (combo To Oily Skin)

Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone

NDC Product Code 51531-5607

NDC CODE: 51531-5607

Proprietary Name: Mary Kay Timewise Miracle Set 3d Sampler (combo To Oily Skin) What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 51531 - Mary Kay Inc.
    • 51531-5607 - Mary Kay Timewise Miracle Set 3d Sampler (combo To Oily Skin)

NDC 51531-5607-0

Package Description: 1 KIT in 1 CARTON * 3 g in 1 PACKET * 1.7 g in 1 TUBE * .5 g in 1 TUBE * 1.7 g in 1 PACKET

NDC Product Information

Mary Kay Timewise Miracle Set 3d Sampler (combo To Oily Skin) with NDC 51531-5607 is a a human over the counter drug product labeled by Mary Kay Inc.. The generic name of Mary Kay Timewise Miracle Set 3d Sampler (combo To Oily Skin) is avobenzone, homosalate, octisalate, octocrylene, and oxybenzone. The product's dosage form is kit and is administered via form.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETEARETH-25 (UNII: 8FA93U5T67)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • PRICKLY PEAR FRUIT (UNII: 18V8PAQ629)
  • SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • RESVERATROL (UNII: Q369O8926L)
  • SUCROSE PALMITATE (UNII: 3OSQ643ZK5)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
  • HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN (UNII: ZFR0T80O4Y)
  • GLYCERYL MONOLINOLEATE (UNII: 4763AXI84L)
  • DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
  • METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
  • ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
  • TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)
  • ETHYL LINALOOL (UNII: SF2JS9GF5T)
  • 2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)
  • 3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)
  • PHENYLISOHEXANOL (UNII: M56178H183)
  • TRIMETHYLBENZENEPROPANOL (UNII: 7S411YY2VY)
  • METHYL BENZODIOXEPINONE (UNII: 0NQ136C313)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mary Kay Inc.
Labeler Code: 51531
FDA Application Number: part352 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 05-16-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Mary Kay Timewise Miracle Set 3d Sampler (combo To Oily Skin) Product Label Images

Mary Kay Timewise Miracle Set 3d Sampler (combo To Oily Skin) Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Age Minimize 3D Day Cream Spf 30 Broad-Spectrum Sunscreen

Drug Facts

Active Ingredients

Avobenzone 3%Homosalate 9%Octisalate 4.5%Octocrylene 3%Oxybenzone 4.5%

Purpose

Sunscreen

Uses

  • Helps prevent sunburnif 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

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.

Directions

  • Apply liberally 15 minutes before sun exposureuse a water resistant sunscreen if swimming or sweatingreapply at least every 2 hoursSun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease thisrisk, 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 sunglasseschildren under 6 months: Ask a doctor

Other Information

  • Protect this product from excessive heat and direct sunstore above 32° F / 0° C

Inactive Ingredients

Water/eau, glycerin, dicaprylyl carbonate, dimethicone, ammonium acryloyldimethyltaurate/VP copolymer, cetearyl alcohol, ceteareth-25,  niacinamide, opuntia ficus-indica fruit extract, saccharomyces cerevisiae extract, tocopheryl acetate, oligopeptide-1, resveratrol, sucrose palmitate, bisabolol, silica, disodium ethylene dicocamide PEG-15 disulfate, hydroxypropyl cyclodextrin, glyceryl linoleate, ethoxydiglycol, methyldihydrojasmonate, ethylene brassylate, tetramethyl acetyloctahydronaphthalenes, ethyl linalool, isobutyl methyl tetrahydropyranol,methylenedioxyphenyl methylpropanal, phenylisohexanol, trimethylbenzenepropanol, methyl benzodioxepinone, triethanolamine, sodium benzoate, disodium EDTA, caprylhydroxamic acid, phenoxyethanol, ethylhexylglycerin, propanediol, caprylyl glycol, iodopropynyl butylcarbamate.

Questions?

Call toll-free 1-800-627-9529

* Please review the disclaimer below.