TENDERTONE LIP BALM SPF 12- octinoxate, octisalate, and avobenzone lipstick
TENDERTONE LIP BALM SPF 12 by
Drug Labeling and Warnings
TENDERTONE LIP BALM SPF 12 by is a Otc medication manufactured, distributed, or labeled by MAKEUP ART COSMETICS, ELGC Kabushiki Kaisha, Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ARAMIS, INC, ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTEC KEYSTONE, NORTHTEC BRISTOL, NORTHTEC KEYSTONE, WHITMAN LABORATORIES, LTD., Aveda Corporation. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- ACTIVE INGREDIENTS
- WARNING
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INGREDIENTS
PETROLATUM, HYDROGENATED POLYISOBUTENE, ETHYLENE/PROPYLENE/STYRENE COPOLYMER, ASTROCARYUM MURUMURU SEED BUTTER, COFFEA ARABICA (COFFEE) SEED EXTRACT, OLEA EUROPAEA (OLIVE) FRUIT EXTRACT, TRITICUM VULGARE (WHEAT BRAN) EXTRACT, TOCOPHERYL ACETATE, WATER, HYDROXYETHYLCELLULOSE, ETHYLCELLULOSE, CHOLESTEROL, PENTAERYTHRITYL ADIPATE/CAPRATE/CAPRYLATE/HEPTANOATE, HYDROGENATED DILINOLEYL ALCOHOL, OCTYLDODECANOL, CAPRYLYL GLYCOL, GLYCERYL STEARATE, LINOLEIC ACID, OLEIC ACID, PALMITIC ACID, POTASSIUM SULFATE, SILICA, CALCIUM SODIUM BOROSILICATE, CALCIUM ALUMINUM BOROSILICATE, ALUMINA, TIN OXIDE, HEXYLENE GLYCOL, BUTYLENE/ETHYLENE/STYRENE COPOLYMER, FRAGRANCE, BHT, PHENOXYETHANOL [+/- MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), BISMUTH OXYCHLORIDE (CI 77163), BLUE 1 (CI 42090), BLUE 1 LAKE (CI 42090), CARMINE (CI 75470), RED 6 (CI 15850), RED 7 (CI 15850), RED 7 LAKE (CI 15850), RED 28 LAKE (CI 45410), RED 30 (CI 73360), RED 33 (CI 17200), YELLOW 5 LAKE (CI 19140), YELLOW 10 (CI 47005), YELLOW 10 LAKE (CI 47005)] <ILN33874>
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 6 ML Jar Carton
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INGREDIENTS AND APPEARANCE
TENDERTONE LIP BALM SPF 12
octinoxate, octisalate, and avobenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 40046-0030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2 mL in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 mL in 100 mL Inactive Ingredients Ingredient Name Strength Petrolatum (UNII: 4T6H12BN9U) Astrocaryum Murumuru Seed Butter (UNII: 12V64UPU6R) Arabica Coffee Bean (UNII: 3SW678MX72) Black Olive (UNII: 2M6QWV94OC) Wheat Bran (UNII: 6L966A1IMR) Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0) Water (UNII: 059QF0KO0R) Ethylcelluloses (UNII: 7Z8S9VYZ4B) Cholesterol (UNII: 97C5T2UQ7J) Octyldodecanol (UNII: 461N1O614Y) Caprylyl Glycol (UNII: 00YIU5438U) Glyceryl Monostearate (UNII: 230OU9XXE4) Linoleic Acid (UNII: 9KJL21T0QJ) Oleic Acid (UNII: 2UMI9U37CP) Palmitic Acid (UNII: 2V16EO95H1) Potassium Sulfate (UNII: 1K573LC5TV) Silicon Dioxide (UNII: ETJ7Z6XBU4) Aluminum Oxide (UNII: LMI26O6933) Stannic Oxide (UNII: KM7N50LOS6) Hexylene Glycol (UNII: KEH0A3F75J) Butylated Hydroxytoluene (UNII: 1P9D0Z171K) Phenoxyethanol (UNII: HIE492ZZ3T) Mica (UNII: V8A1AW0880) Titanium Dioxide (UNII: 15FIX9V2JP) Ferric Oxide Red (UNII: 1K09F3G675) Ferric Oxide Yellow (UNII: EX438O2MRT) Ferrosoferric Oxide (UNII: XM0M87F357) Bismuth Oxychloride (UNII: 4ZR792I587) FD&C Blue No. 1 (UNII: H3R47K3TBD) Cochineal (UNII: TZ8Z31B35M) D&C Red No. 6 (UNII: 481744AI4O) D&C Red No. 7 (UNII: ECW0LZ41X8) D&C Red No. 28 (UNII: 767IP0Y5NH) D&C Red No. 30 (UNII: 2S42T2808B) D&C Red No. 33 (UNII: 9DBA0SBB0L) FD&C Yellow No. 5 (UNII: I753WB2F1M) D&C Yellow No. 10 (UNII: 35SW5USQ3G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 40046-0030-1 1 in 1 CARTON 1 6 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 01/01/2007 Labeler - MAKEUP ART COSMETICS (010597206) Establishment Name Address ID/FEI Business Operations ELGC Kabushiki Kaisha 712808195 RELABEL(40046-0030) , REPACK(40046-0030) Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) 828534516 MANUFACTURE(40046-0030) , RELABEL(40046-0030) , REPACK(40046-0030) Establishment Name Address ID/FEI Business Operations ARAMIS, INC 042918826 MANUFACTURE(40046-0030) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS DISTRIBUTION CENTER 208579636 RELABEL(40046-0030) , REPACK(40046-0030) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 253616536 MANUFACTURE(40046-0030) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 255175580 MANUFACTURE(40046-0030) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD. 205952385 MANUFACTURE(40046-0030) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 MANUFACTURE(40046-0030) Establishment Name Address ID/FEI Business Operations LEN-RON MANUFACTURING DIVISION OF ARAMIS INC 809771152 MANUFACTURE(40046-0030) Establishment Name Address ID/FEI Business Operations NORTEC KEYSTONE 787336577 MANUFACTURE(40046-0030) , RELABEL(40046-0030) , REPACK(40046-0030) Establishment Name Address ID/FEI Business Operations NORTHTEC BRISTOL 949264774 MANUFACTURE(40046-0030) , RELABEL(40046-0030) , REPACK(40046-0030) Establishment Name Address ID/FEI Business Operations NORTHTEC KEYSTONE 618107429 MANUFACTURE(40046-0030) , RELABEL(40046-0030) , REPACK(40046-0030) Establishment Name Address ID/FEI Business Operations WHITMAN LABORATORIES, LTD. 216866277 MANUFACTURE(40046-0030) Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 MANUFACTURE(40046-0030)
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