NDC 51531-1606 Mary Kay Timewise Repair Volu-firm Sampler Set

Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone

NDC Product Code 51531-1606

NDC Code: 51531-1606

Proprietary Name: Mary Kay Timewise Repair Volu-firm Sampler Set 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.
    • 51531-1606 - Mary Kay Timewise Repair Volu-firm Sampler Set

NDC 51531-1606-0

Package Description: 1 KIT in 1 PACKAGE * 2 mL in 1 PACKET * 1.7 g in 1 PACKET * .3 g in 1 PACKET * 2 g in 1 PACKET * 1.7 g in 1 PACKET

NDC Product Information

Mary Kay Timewise Repair Volu-firm Sampler Set with NDC 51531-1606 is a a human over the counter drug product labeled by Mary Kay Inc.. The generic name of Mary Kay Timewise Repair Volu-firm Sampler Set is avobenzone, homosalate, octisalate, octocrylene, and oxybenzone. The product's dosage form is kit and is administered via form.

Labeler Name: Mary Kay Inc.

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)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • CETEARETH-25 (UNII: 8FA93U5T67)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
  • DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
  • CALCIUM 2-KETOGLUCONATE (UNII: 8K5SM7SI6Y)
  • HEXYLRESORCINOL (UNII: R9QTB5E82N)
  • 4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ETHYL LINALOOL (UNII: SF2JS9GF5T)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • DECYLENE GLYCOL (UNII: S57M60MI88)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN (UNII: ZFR0T80O4Y)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CENTELLA ASIATICA (UNII: 7M867G6T1U)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • TRIMETHYLBENZENEPROPANOL (UNII: 7S411YY2VY)
  • 2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)
  • MILK THISTLE (UNII: U946SH95EE)
  • .GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • PHENYLISOHEXANOL (UNII: M56178H183)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • CESTRUM LATIFOLIUM LEAF (UNII: O2618B6E88)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE (UNII: 0UBP26S1LG)
  • PREZATIDE (UNII: 39TG2H631E)

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: 08-16-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Mary Kay Timewise Repair Volu-firm Sampler Set Product Label Images

Mary Kay Timewise Repair Volu-firm Sampler Set 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

Inactive Ingredients

WATER, GLYCERIN, POTASSIUM STEARATE, DIPROPYLENE GLYCOL, SORBITOL, POTASSIUM MYRISTATE, MYRISTIC ACID, GLYCERYL STEARATE SE, PEG-60 GLYCERYL ISOSTEARATE, STEARIC ACID, SODIUM METHYL COCOYL TAURATE, PEG-32, POTASSIUM LAURATE, GLYCOL STEARATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, TOCOPHEROL, TRIPEPTIDE-1, CENTELLA ASIATICA FLOWER/LEAF/STEM EXTRACT, PEG-6, BUTYLENE GLYCOL, POLYQUATERNIUM-7, LAURIC ACID, SODIUM CHLORIDE, MALTODEXTRIN, ETHYLENE BRASSYLATE, ETHYL LINALOOL, PEG-4 LAURATE, TRIMETHYLBENZENEPROPANOL, ISOBUTYL METHYL TETRAHYDROPYRANOL, GAMMA-UNDECALACTONE, PHENYLISOHEXANOL, SUBTILISIN, METHYLDIHYDROJASMONATE, LIPASE, TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE, IODOPROPYNYL BUTYLCARBAMATE.

CYCLOPENTASILOXANE, WATER, GLYCERIN, SILICA, PEG-10 DIMETHICONE, POLYMETHYLSILSESQUIOXANE, DIMETHICONE, POLYSILICONE-11, PENTYLENE GLYCOL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, CAPRYLIC/CAPRIC TRIGLYCERIDE, SECALE CEREALE (RYE) SEED EXTRACT, ALPINIA GALANGA LEAF EXTRACT, SCHISANDRA CHINENSIS FRUIT EXTRACT, CENTELLA ASIATICA MERISTEM CELL CULTURE, PISUM SATIVUM (PEA) EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER/LEAF/STEM EXTRACT, ALTEROMONAS FERMENT FILTRATE, CAMELLIA SINENSIS LEAF EXTRACT, PRUNUS PERSICA (PEACH) FRUIT EXTRACT, TOCOPHEROL, TRIPEPTIDE-1, SORBITOL, BUTYLENE GLYCOL, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, POLYSORBATE 40, MENTHYL LACTATE, ROSE EXTRACT, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, VANILLA PLANIFOLIA FRUIT EXTRACT, JASMINUM OFFICINALE (JASMINE) FLOWER/LEAF EXTRACT, FUCUS VESICULOSUS EXTRACT, PASSIFLORA EDULIS FRUIT EXTRACT, PRUNUS ARMENIACA (APRICOT) FRUIT EXTRACT, MENTHA PIPERITA (PEPPERMINT) EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, SANTALUM ALBUM (SANDALWOOD) WOOD EXTRACT, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT EXTRACT, CANANGA ODORATA FLOWER EXTRACT, RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT, CORIANDRUM SATIVUM (CORIANDER) FRUIT/LEAF EXTRACT, CUPRESSUS SEMPERVIRENS LEAF/STEM EXTRACT, CUCUMIS MELO CANTALUPENSIS FRUIT EXTRACT, SODIUM CHLORIDE, CYCLOHEXASILOXANE, DISODIUM EDTA, TRIETHANOLAMINE, DIHYDROXY METHYLCHROMONE, SODIUM CITRATE, XANTHAN GUM, TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE, HYDROXYPROPYL CYCLODEXTRIN, ALCOHOL, PHENOXYETHANOL, CAPRYLYL GLYCOL, IODOPROPYNYL BUTYLCARBAMATE, CHLORPHENESIN, TIN OXIDE, MICA, TITANIUM DIOXIDE.

Water, butylene glycol, glycerin, cetearyl alcohol, behenyl alcohol, dicaprylyl carbonate, ammonium acryloyldimethyltaurate/VP copolymer, dimethicone, ceteareth-25, pentylene glycol, tripeptide-1, tocopheryl acetate, hexylresorcinol, sodium PCA, centella asiatica meristem cell culture, silybum marianum fruit extract, cestrum latifolium leaf extract, calcium ketogluconate, 4-t-butylcyclohexanol, disodium ethylene dicocamide PEG-15 disulfate, bisabolol, xanthan gum, methyldihydrojasmonate, ethylene brassylate, ethyl linalool, disodium EDTA, trimethylbenzenepropanol, isobutyl methyl tetrahydropyranol, gamma-undecalactone, phenylisohexanol, sodium benzoate, tetradecyl aminobutyroylvalylaminobutyric urea trifluoroacetate, silica, triethanolamine, citric acid, propanediol, caprylyl glycol, decylene glycol,  hydroxypropyl cyclodextrin, phenoxyethanol, hexylene glycol, ethylhexylglycerin, 1,2-hexanediol, iodopropynyl butylcarbamate.

Volu-Firm Day Cream Sunscreen Broad-Spectrum Spf 30 0.06 Oz. Net Wt. / 1.7 G

Drug Facts

Active Ingredients

Avobenzone 3%Homosalate 9%Octisalate 4.5%Octocrylene 4%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 below 32 F / 0 C

Ingredients:

WATER, GLYCERIN, HYDROGENATED POLYDECENE, CYCLOPENTASILOXANE, CETEARYL ALCOHOL, DIPROPYLENE GLYCOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, GLYCERYL STEARATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ISOCETYL STEARATE, RETINOL, PUNICA GRANATUM FRUIT EXTRACT, CODIUM TOMENTOSUM EXTRACT, TRIPEPTIDE-1, CENTELLA ASIATICA MERISTEM CELL CULTURE, CINNAMOMUM CASSIA BARK EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, BUTYLENE GLYCOL, POLYGLYCERYL-2 TRIISOSTEARATE, PEG-100 STEARATE, POLYMETHYL METHACRYLATE, CETEARYL GLUCOSIDE, DIMETHICONE, TRICAPRYLIN, TRIETHANOLAMINE, DISODIUM EDTA, CARBOMER, HYDROXYPROPYL CYCLODEXTRIN, CYCLOHEXASILOXANE, XANTHAN GUM, TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE, CAPRYLYL GLYCOL, PHENOXYETHANOL, IODOPROPYNYL BUTYLCARBAMATE, CHLORPHENESIN, BHT.

WATER, GLYCERIN, PETROLATUM, MINERAL OIL, HYDROGENATED POLYDECENE, CETYL ESTERS, BIS-DIGLYCERYL POLYACYLADIPATE-2, BUTYLENE GLYCOL, HYDROGENATED POLYISOBUTENE, SORBITAN OLIVATE, CETEARYL OLIVATE, HEXYLDECANOL, CETYL PALMITATE, TETRAHEXYLDECYL ASCORBATE, MAGNOLIA GRANDIFLORA BARK EXTRACT, CENTELLA ASIATICA EXTRACT, BISABOLOL, HESPERIDIN METHYL CHALCONE, PISUM SATIVUM (PEA) EXTRACT, CITRUS GRANDIS (GRAPEFRUIT) PEEL EXTRACT, MAGNOLIA BIONDII FLOWER EXTRACT, TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE, CENTELLA ASIATICA MERISTEM CELL CULTURE, DIPEPTIDE-2, PALMITOYL TETRAPEPTIDE-7, TRIPEPTIDE-1, BRASSICA CAMPESTRIS (RAPESEED) STEROLS, TOCOPHERYL ACETATE, STEARETH-20, STEARIC ACID, PROPYLENE GLYCOL, CETYLHYDROXYPROLINE PALMITAMIDE, SORBITAN PALMITATE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CETEARYL ALCOHOL, CETEARETH-20, TRIETHANOLAMINE, DISODIUM EDTA, SILICA, ETHYLENE/METHACRYLATE COPOLYMER, ISOPROPYL TITANIUM TRIISOSTEARATE, HYDROXYPROPYL CYCLODEXTRIN, SODIUM CITRATE, POTASSIUM BENZOATE, CHLORHEXIDINE DIGLUCONATE, PHENOXYETHANOL, DIAZOLIDINYL UREA, IODOPROPYNYL BUTYLCARBAMATE.

* Please review the disclaimer below.