Label: TENDERTONE LIP BALM SPF 12- octinoxate, octisalate, and avobenzone lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 40046-0030-1 - Packager: MAKEUP ART COSMETICS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 January 17, 2012
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- 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)
