Label: MARY KAY TIMEWISE REPAIR VOLU-FIRM DAY CREAM BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream
- NDC Code(s): 51531-0549-3, 51531-0549-7
- Packager: Mary Kay Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 24, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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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
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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 trifuoroacetate, silica, triethanolamine, citric acid, propanediol, caprylyl glycol, decylene glycol, hydroxypropyl cyclodextrin, phenoxyethanol, hexylene glycol, ethylhexylglycerin, 1,2-hexanediol, magnesium chloride, iodopropynyl butylcarbamate
- Other information
- Questions or comments?
- Principal Display Panel - 48 g carton
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INGREDIENTS AND APPEARANCE
MARY KAY TIMEWISE REPAIR VOLU-FIRM DAY CREAM BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51531-0549 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DOCOSANOL (UNII: 9G1OE216XY) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) DIMETHICONE (UNII: 92RU3N3Y1O) 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) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51531-0549-7 1 in 1 CARTON 05/16/2019 1 48 g in 1 JAR; Type 0: Not a Combination Product 2 NDC:51531-0549-3 9 g in 1 TUBE; Type 0: Not a Combination Product 05/16/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 05/16/2019 Labeler - Mary Kay Inc. (049994452) Establishment Name Address ID/FEI Business Operations Englewood Lab Inc. 172198223 manufacture(51531-0549) Establishment Name Address ID/FEI Business Operations Mary Kay Inc. 103978839 manufacture(51531-0549)
