RxNorm Names

Review RxNorm Normal Forms

TENDERTONE LIP BALM SPF 12 (octinoxate, octisalate, and avobenzone) lipstick
[MAKEUP ART COSMETICS]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=f75ccb8e-9947-4921-9dc7-20816dee7372

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not final

NOTE: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 Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

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 (OCTINOXATE)	OCTINOXATE	7.5 mL in 100 mL
OCTISALATE (OCTISALATE)	OCTISALATE	2 mL in 100 mL
AVOBENZONE (AVOBENZONE)	AVOBENZONE	1.5 mL in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description
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: 01/2012

Document Id: 55e576e5-b615-429a-90f5-f741d3d48209

Set id: f75ccb8e-9947-4921-9dc7-20816dee7372

Version: 1

Effective Time: 20120117

MAKEUP ART COSMETICS

Daily Med

Current Medication Information

Options