TENDERTONE LIP BALM SPF 12

Dosage form: lipstick
Ingredients: OCTINOXATE 7.5mL in 100mL, OCTISALATE 2mL in 100mL, AVOBENZONE 1.5mL in 100mL
Labeler: MAKEUP ART COSMETICS
NDC Code: 40046-0030

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.

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

TENDERTONE LIP BALM SPF 12 
octinoxate, octisalate, and avobenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
1NDC:40046-0030-11 JAR (JAR) 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/FEIOperations
ELGC Kabushiki Kaisha712808195RELABEL(40046-0030), REPACK(40046-0030)
Establishment
NameAddressID/FEIOperations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)828534516MANUFACTURE(40046-0030), RELABEL(40046-0030), REPACK(40046-0030)
Establishment
NameAddressID/FEIOperations
ARAMIS, INC042918826MANUFACTURE(40046-0030)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER208579636RELABEL(40046-0030), REPACK(40046-0030)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD253616536MANUFACTURE(40046-0030)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD255175580MANUFACTURE(40046-0030)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER COSMETICS, LTD.205952385MANUFACTURE(40046-0030)
Establishment
NameAddressID/FEIOperations
ESTEE LAUDER N.V.370151326MANUFACTURE(40046-0030)
Establishment
NameAddressID/FEIOperations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC809771152MANUFACTURE(40046-0030)
Establishment
NameAddressID/FEIOperations
NORTEC KEYSTONE787336577MANUFACTURE(40046-0030), RELABEL(40046-0030), REPACK(40046-0030)
Establishment
NameAddressID/FEIOperations
NORTHTEC BRISTOL949264774MANUFACTURE(40046-0030), RELABEL(40046-0030), REPACK(40046-0030)
Establishment
NameAddressID/FEIOperations
NORTHTEC KEYSTONE618107429MANUFACTURE(40046-0030), RELABEL(40046-0030), REPACK(40046-0030)
Establishment
NameAddressID/FEIOperations
WHITMAN LABORATORIES, LTD.216866277MANUFACTURE(40046-0030)
Establishment
NameAddressID/FEIOperations
Aveda Corporation071352058MANUFACTURE(40046-0030)

Revised: 01/2012
 
MAKEUP ART COSMETICS

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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