TENDERTONE LIP BALM SPF 12- octinoxate, octisalate and avobenzone lipstick 
MAKEUP ART COSMETICS

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.

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MAC
TENDERTONE
LIP BALM SPF 12

ACTIVE INGREDIENTS

OCTINOXATE 7.50%, OCTISALATE 2.00%, AVOBENZONE 1.50%

WARNING

STOP USE IF IRRITATION OCCURS.

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>

DIST. BY: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7
LONDON W1K 3BQ / MLWC

PRINCIPAL DISPLAY PANEL - 6 ML Jar Carton

MAC

TENDERTONE
LIP BALM SPF 12

6 ML/0.2 US FL OZ e

PRINCIPAL DISPLAY PANEL - 6 ML Jar Carton
TENDERTONE LIP BALM SPF 12 
octinoxate, octisalate, and avobenzone lipstick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0030
Route of Administration TOPICAL DEA Schedule     
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)

Revised: 1/2012
Document Id: 55e576e5-b615-429a-90f5-f741d3d48209
Set id: f75ccb8e-9947-4921-9dc7-20816dee7372
Version: 1
Effective Time: 20120117
 
MAKEUP ART COSMETICS