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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:40046-0030
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE2 mL  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE1.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Petrolatum 
Astrocaryum Murumuru Seed Butter 
Arabica Coffee Bean 
Black Olive 
Wheat Bran 
Alpha-Tocopherol Acetate 
Water 
Ethylcelluloses 
Cholesterol 
Octyldodecanol 
Caprylyl Glycol 
Glyceryl Monostearate 
Linoleic Acid 
Oleic Acid 
Palmitic Acid 
Potassium Sulfate 
Silicon Dioxide 
Aluminum Oxide 
Stannic Oxide 
Hexylene Glycol 
Butylated Hydroxytoluene 
Phenoxyethanol 
Mica 
Titanium Dioxide 
Ferric Oxide Red 
Ferric Oxide Yellow 
Ferrosoferric Oxide 
Bismuth Oxychloride 
FD&C Blue No. 1 
Cochineal 
D&C Red No. 6 
D&C Red No. 7 
D&C Red No. 28 
D&C Red No. 30 
D&C Red No. 33 
FD&C Yellow No. 5 
D&C Yellow No. 10 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40046-0030-11 in 1 CARTON
16 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/2007
Labeler - MAKEUP ART COSMETICS (010597206)
Establishment
NameAddressID/FEIBusiness Operations
ELGC Kabushiki Kaisha712808195RELABEL(40046-0030), REPACK(40046-0030)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(40046-0030), RELABEL(40046-0030), REPACK(40046-0030)
Establishment
NameAddressID/FEIBusiness Operations
ARAMIS, INC042918826MANUFACTURE(40046-0030)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636RELABEL(40046-0030), REPACK(40046-0030)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(40046-0030)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(40046-0030)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(40046-0030)
Establishment
NameAddressID/FEIBusiness Operations
ESTEE LAUDER N.V.370151326MANUFACTURE(40046-0030)
Establishment
NameAddressID/FEIBusiness Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(40046-0030)
Establishment
NameAddressID/FEIBusiness Operations
NORTEC KEYSTONE787336577MANUFACTURE(40046-0030), RELABEL(40046-0030), REPACK(40046-0030)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC BRISTOL949264774MANUFACTURE(40046-0030), RELABEL(40046-0030), REPACK(40046-0030)
Establishment
NameAddressID/FEIBusiness Operations
NORTHTEC KEYSTONE618107429MANUFACTURE(40046-0030), RELABEL(40046-0030), REPACK(40046-0030)
Establishment
NameAddressID/FEIBusiness Operations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(40046-0030)
Establishment
NameAddressID/FEIBusiness Operations
Aveda Corporation071352058MANUFACTURE(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