Label: MKMEN ADVANCED FACIAL HYDRATOR SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
- NDC Code(s): 51531-0288-3
- 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 October 11, 2022
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
-
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, glycereth-26, dimethicone, glycerin, C12-15 alkyl benzoate, phenethyl benzoate, styrene/acrylates copolymer, trisiloxane, polyester-7, benzyl alcohol, butylene glycol, polymethylsilsesquioxane, ethylene/acrylic acid copolymer, betaine, glyceryl stearate, dimethicone, PEG-100 stearate, neopentyl glycol diheptanoate, butyrospermum parkii (shea) butter, squalane, dipropylene glycol dibenzoate, panthenol, allantoin, tocopheryl acetate, arachidyl alcohol, methyl trimethicone, dimethyl capramide, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, acrylates/dimethicone copolymer, pentylene glycol, behenyl alcohol, potassium cetyl phosphate, hydrogenated palm glycerides, arachidyl glucoside, PPG-15 stearyl ether benzoate, C9-15 alkyl phosphate, polysorbate 60, hydrogenated lecithin, sodium PCA, lauramine oxide, disodium EDTA, triethanolamine, xanthan gum, sorbitan isostearate, sorbic acid, methylparaben, caprylyl glycol, phenoxyethanol, methyldihydrojasmonate, ethylene brassylate, ethyl linalool, trimethylbenzenepropanol, isobutyl methyl tetrahydropyranol, ammonium hydroxide, gamma-undecalactone, phenylisohexanol, BHT
- Other information
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- Principal Display Panel - 88 mL carton
-
INGREDIENTS AND APPEARANCE
MKMEN ADVANCED FACIAL HYDRATOR SUNSCREEN SPF 30
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51531-0288 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) TRISILOXANE (UNII: 9G1ZW13R0G) GLYCERETH-26 (UNII: NNE56F2N14) GLYCERIN (UNII: PDC6A3C0OX) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) PHENETHYL BENZOATE (UNII: 0C143929GK) POLYESTER-7 (UNII: 0841698D2F) BENZYL ALCOHOL (UNII: LKG8494WBH) BETAINE (UNII: 3SCV180C9W) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DIMETHICONE (UNII: 92RU3N3Y1O) PEG-100 STEARATE (UNII: YD01N1999R) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) PHENOXYETHANOL (UNII: HIE492ZZ3T) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) METHYL TRIMETHICONE (UNII: S73ZQI0GXM) DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ) SQUALANE (UNII: GW89575KF9) SHEA BUTTER (UNII: K49155WL9Y) PENTYLENE GLYCOL (UNII: 50C1307PZG) DOCOSANOL (UNII: 9G1OE216XY) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) XANTHAN GUM (UNII: TTV12P4NEE) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) EDETATE DISODIUM (UNII: 7FLD91C86K) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) METHYLPARABEN (UNII: A2I8C7HI9T) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M) POLYSORBATE 60 (UNII: CAL22UVI4M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PANTHENOL (UNII: WV9CM0O67Z) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) SORBIC ACID (UNII: X045WJ989B) ALLANTOIN (UNII: 344S277G0Z) METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) TROLAMINE (UNII: 9O3K93S3TK) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD) ETHYL LINALOOL (UNII: SF2JS9GF5T) TRIMETHYLBENZENEPROPANOL (UNII: 7S411YY2VY) 2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F) AMMONIA (UNII: 5138Q19F1X) .GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL) PHENYLISOHEXANOL (UNII: M56178H183) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51531-0288-3 1 in 1 CARTON 05/16/2013 1 88 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 05/16/2013 Labeler - Mary Kay Inc. (049994452) Establishment Name Address ID/FEI Business Operations Mary Kay Inc. 103978839 manufacture(51531-0288)
