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Product NDC Code | 51531-1614 | ||||
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Drug Name | Mary kay timewise repair volu-firm the go set |
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Type | Brand | ||||
Dosage Form | KIT | ||||
Application Number | M020 | ||||
Labeler Name | Mary Kay Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Avobenzone 3% Homosalate 9% Octisalate 4.5% Octocrylene 4% Oxybenzone 4.5% Purpose Sunscreen
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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, SODIUM BENZOATE, MAGNESIUM CHLORIDE.
Inactive ingredients 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, CYCLODEXTRIN, MALODEXTRIN, ALTEROMONAS FERMENT FILTRATE, MAGNESIUM CHLORIDE.
Inactive ingredients 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, magnesium chloride.
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, MAGNESIUM CHLORIDE.
INGREDIENTS: 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, MAGNESIUM CHLORIDE.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Mary Kay TimeWise Repair Volu-Firm The Go Set Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone TimeWise Repair Volu-Firm Day Cream SPF 30 Broad Spectrum Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone WATER GLYCERIN DIMETHICONE BUTYLENE GLYCOL CETOSTEARYL ALCOHOL DOCOSANOL DICAPRYLYL CARBONATE AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER CETEARETH-25 PENTYLENE GLYCOL PHENOXYETHANOL METHYL DIHYDROJASMONATE (SYNTHETIC) DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE CALCIUM 2-KETOGLUCONATE HEXYLRESORCINOL 4-TERT-BUTYLCYCLOHEXANOL SILICON DIOXIDE ETHYLENE BRASSYLATE CAPRYLYL GLYCOL EDETATE DISODIUM ETHYL LINALOOL TROLAMINE LEVOMENOL DECYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN 1,2-HEXANEDIOL CENTELLA ASIATICA ETHYLHEXYLGLYCERIN HEXYLENE GLYCOL SODIUM PYRROLIDONE CARBOXYLATE TRIMETHYLBENZENEPROPANOL 2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL MILK THISTLE .GAMMA.-UNDECALACTONE CITRIC ACID MONOHYDRATE PHENYLISOHEXANOL PROPANEDIOL IODOPROPYNYL BUTYLCARBAMATE CESTRUM LATIFOLIUM LEAF XANTHAN GUM SODIUM BENZOATE TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE PREZATIDE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE OXYBENZONE OXYBENZONE MAGNESIUM CHLORIDE TimeWise Repair Volu-Firm Foaming Cleanser WATER GLYCERIN POTASSIUM STEARATE DIPROPYLENE GLYCOL SORBITOL POTASSIUM MYRISTATE MYRISTIC ACID GLYCERYL STEARATE SE PEG-60 GLYCERYL ISOSTEARATE STEARIC ACID SODIUM METHYL COCOYL TAURATE POLYETHYLENE GLYCOL 1600 POTASSIUM LAURATE GLYCOL STEARATE POLYETHYLENE GLYCOL 300 METHYL DIHYDROJASMONATE (SYNTHETIC) BUTYLENE GLYCOL POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) LAURIC ACID SODIUM CHLORIDE MALTODEXTRIN PEG-4 LAURATE ETHYLENE BRASSYLATE ETHYL LINALOOL TRIMETHYLBENZENEPROPANOL 2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL .GAMMA.-UNDECALACTONE IODOPROPYNYL BUTYLCARBAMATE PHENYLISOHEXANOL SUNFLOWER OIL SUBTILISIN TOCOPHEROL CENTELLA ASIATICA FLOWERING TOP PANCRELIPASE LIPASE TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE PREZATIDE SODIUM BENZOATE MAGNESIUM CHLORIDE TimeWise Repair Volu-Firm Lifting Serum MALTODEXTRIN MAGNESIUM CHLORIDE WATER CYCLOMETHICONE 5 GLYCERIN SILICON DIOXIDE HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER PEG-10 DIMETHICONE (600 CST) DIMETHICONE PENTYLENE GLYCOL POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) PHENOXYETHANOL AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER TITANIUM DIOXIDE BUTYLENE GLYCOL POLYSORBATE 40 SORBITOL MICA CAPRYLYL GLYCOL CHLORPHENESIN SCHISANDRA CHINENSIS FRUIT MEDIUM-CHAIN TRIGLYCERIDES MENTHYL LACTATE, (-)- HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN SODIUM CHLORIDE RYE ALPINIA GALANGA LEAF CENTELLA ASIATICA CYCLOMETHICONE 6 EDETATE DISODIUM TROLAMINE 5,7-DIHYDROXY-2-METHYLCHROMONE PEA LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP SODIUM CITRATE STANNIC OXIDE IODOPROPYNYL BUTYLCARBAMATE XANTHAN GUM ALCOHOL GREEN TEA LEAF MENTHA PIPERITA APRICOT PEACH TOCOPHEROL CANANGA ODORATA FLOWER BERGAMOT OIL CORIANDER CANTALOUPE CUCUMBER CUPRESSUS SEMPERVIRENS LEAFY TWIG FUCUS VESICULOSUS JASMINUM OFFICINALE FLOWER PASSIFLORA EDULIS FRUIT APPLE ROSA CANINA FLOWER ROSEMARY RASPBERRY SANDALWOOD VANILLA TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE PREZATIDE CYCLODEXTRINS ALTEROMONAS MACLEODII POLYSACCHARIDES TimeWise Repair Volu-Firm Night Treatment with Retinol MAGNESIUM CHLORIDE WATER GLYCERIN HYDROGENATED POLYDECENE (550 MW) CYCLOMETHICONE 5 CETOSTEARYL ALCOHOL DIPROPYLENE GLYCOL SHEA BUTTER GLYCERYL MONOSTEARATE MEDIUM-CHAIN TRIGLYCERIDES ISOCETYL STEARATE BUTYLENE GLYCOL POLYGLYCERYL-2 TRIISOSTEARATE PHENOXYETHANOL PEG-100 STEARATE POLY(METHYL METHACRYLATE; 450000 MW) CETEARYL GLUCOSIDE DIMETHICONE TRICAPRYLIN CHLORPHENESIN TROLAMINE CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) EDETATE DISODIUM BUTYLATED HYDROXYTOLUENE HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN RETINOL CENTELLA ASIATICA CYCLOMETHICONE 6 POMEGRANATE CODIUM TOMENTOSUM CHINESE CINNAMON GLYCYRRHIZA GLABRA IODOPROPYNYL BUTYLCARBAMATE CAPRYLYL GLYCOL XANTHAN GUM TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE PREZATIDE TimeWise Repair Volu-Firm Eye Renewal Cream MAGNESIUM CHLORIDE WATER GLYCERIN MINERAL OIL PETROLATUM HYDROGENATED POLYDECENE (550 MW) CETYL ESTERS WAX BIS-DIGLYCERYL POLYACYLADIPATE-2 BUTYLENE GLYCOL HYDROGENATED POLYBUTENE (1300 MW) SORBITAN OLIVATE CETEARYL OLIVATE HEXYLDECANOL CETYL PALMITATE CETOSTEARYL ALCOHOL SORBITAN MONOPALMITATE TETRAHEXYLDECYL ASCORBATE SILICON DIOXIDE POLYOXYL 20 CETOSTEARYL ETHER DIAZOLIDINYL UREA .ALPHA.-TOCOPHEROL ACETATE TROLAMINE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) LEVOMENOL CENTELLA ASIATICA PROPYLENE GLYCOL HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN MAGNOLIA GRANDIFLORA BARK CETYLHYDROXYPROLINE PALMITAMIDE EDETATE DISODIUM HESPERIDIN METHYLCHALCONE STEARETH-20 STEARIC ACID PEA RAPESEED STEROL PHENOXYETHANOL CITRUS MAXIMA FRUIT RIND ISOPROPYL TITANIUM TRIISOSTEARATE SODIUM CITRATE IODOPROPYNYL BUTYLCARBAMATE CHLORHEXIDINE GLUCONATE MAGNOLIA BIONDII FLOWER VALYLTRYPTOPHAN POTASSIUM BENZOATE PALMITOYL TETRAPEPTIDE-7 PREZATIDE TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel - The Go Set carton Mary Kay TimeWise Repair Volu-Firm The Go Set FOR THE ADVANCED SIGNS OF AGING this set contains: Volu-Firm Foaming Cleanser 0.5 OZ. NET WT. / 14 g Volu-Firm Lifting Serum 0.25 FL. OZ. / 8 ml Volu-Firm Day Cream Sunscreen Broad-Spectrum SPF 30 0.3 OZ. NET WT. / 9 g Volu-Firm Night Treatment with Retinol 10.3 OZ. NET WT. / 9 g Volu-Firm Eye Renewal Cream 0.1 OZ. NET WT. / 3 g image of the Go Set carton
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged or broken skin
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? Call toll free 1-800-627-9529
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if rash occurs
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product keep out of eyes. Rinse with water to remove.
Storage and handling
Information about safe storage and handling of the drug product.Other information protect this product from excessive heat and direct sun store below 32 F / 0 C
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API