TINTED LIP CONDITIONER

Manufacturer: MAKEUP ART COSMETICS | ESTEE LAUDER COSMETICS, LTD | ESTEE LAUDER N.V. | Len-Ron Manufacturing Division of Aramis Inc. | Aramis Inc. | Northtec Bristol | Northtec Keystone | Estee Lauder Pennsylvania Distribution Center 2 | Estee Lauder Cosmetics, Ltd. | Estee Lauder Cosmetics Distribution Center | Estee Lauder Kabushiki Kaisha | Whitman Laboratories Ltd. | Aveda Corporation
Effective date: 2011-09-12
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:29:30

Label at a glance#

ProductTINTED LIP CONDITIONER SPF 15

Active ingredientOCTINOXATE, OCTISALATE

Label structure4 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 5.00%

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: PETROLATUM [] RICINUS COMMUNIS (CASTOR) SEED OIL [] POLYBUTENE [] MICROCRYSTALLINE WAX \CERA MICROCRISTALLINA\CIRE MICROCRISTALLINE [] ETHYLENE/PROPYLENE/STYRENE COPOLYMER [] HYDROGENATED POLYISOBUTENE [] FRAGRANCE (PARFUM) [] SILICA [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] PERSEA GRATISSIMA (AVOCADO) OIL UNSAPONIFIABLES [] TRITICUM VULGARE (WHEAT) GERM OIL [] CHAMOMILLA RECUTITA (MATRICARIA) FLOWER OIL [] ASTROCARYUM MURUMURU BUTTER [] PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL [] TOCOPHERYL ACETATE [] RETINYL PALMITATE [] CHOLESTEROL [] LECITHIN [] SQUALANE [] POLYETHYLENE [] POLYDECENE [] BUTYLENE/ETHYLENE/STYRENE COPOLYMER [] TRIETHOXYCAPRYLYLSILANE [] TETRAHEXYLDECYL ASCORBATE [] SACCHARIN [] VANILLIN [] BHT

WARNINGS SECTION

WARNING: STOP USE IF IRRITATION OCCURS.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL:

MAC

LIP CONDITIONER SPF 15

15 ML/0.5 US FL OZ.

DISTR. BY MAKEUP ART COSMETICS
TORONTO, ONTARIO, CANADA, M5V 1R7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
40046-0049-1	2019-10-29	C162847	48780-1	960f7f55-c8c0-8e05-e053-dbdaa90a074a	5006df08-636d-4633-991b-e2178369edaf

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
40046-0049-1	TINTED LIP CONDITIONERSPF 15	1 in 1 CARTON	GEL	1		1
40046-0049-2	TINTED LIP CONDITIONERSPF 15	15 mL in 1 JAR	GEL	15		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
40046-0049	TINTED LIP CONDITIONER SPF 15 (OCTINOXATE, OCTISALATE) GEL [MAKEUP ART COSMETICS]	1	Legacy NDC, 2 package rows	20110913_5006df08-636d-4633-991b-e2178369edaf.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	1
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	1
ASTROCARYUM MURUMURU SEED BUTTER	INACTIVE INGREDIENT	12V64UPU6R	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	1
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	1
CHOLESTEROL	INACTIVE INGREDIENT	97C5T2UQ7J	1
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	1
MICROCRYSTALLINE WAX	INACTIVE INGREDIENT	XOF597Q3KY	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
POLYISOBUTYLENE (35000 MW)	INACTIVE INGREDIENT	98553S1MHQ	1
SACCHARIN	INACTIVE INGREDIENT	FST467XS7D	1
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
STANNIC OXIDE	INACTIVE INGREDIENT	KM7N50LOS6	1
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	1
WHEAT GERM OIL	INACTIVE INGREDIENT	14C97E680P	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

TINTED LIP CONDITIONER SPF 15
OCTINOXATE, OCTISALATE
OCTINOXATE
OCTISALATE
PETROLATUM
CASTOR OIL
MICROCRYSTALLINE WAX
SILICON DIOXIDE
POLYISOBUTYLENE (35000 MW)
LECITHIN, SOYBEAN
ALMOND OIL
SHEA BUTTER
ASTROCARYUM MURUMURU SEED BUTTER
CHOLESTEROL
WHEAT GERM OIL
HIGH DENSITY POLYETHYLENE
TRIETHOXYCAPRYLYLSILANE
STANNIC OXIDE
SACCHARIN
BUTYLATED HYDROXYTOLUENE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
40046-0049	40046-0049-2, 40046-0049-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
PETROLATUM	4T6H12BN9U	IACT
CASTOR OIL	D5340Y2I9G	IACT
MICROCRYSTALLINE WAX	XOF597Q3KY	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
POLYISOBUTYLENE (35000 MW)	98553S1MHQ	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
ALMOND OIL	66YXD4DKO9	IACT
SHEA BUTTER	K49155WL9Y	IACT
ASTROCARYUM MURUMURU SEED BUTTER	12V64UPU6R	IACT
CHOLESTEROL	97C5T2UQ7J	IACT
WHEAT GERM OIL	14C97E680P	IACT
HIGH DENSITY POLYETHYLENE	UG00KM4WR7	IACT
TRIETHOXYCAPRYLYLSILANE	LDC331P08E	IACT
STANNIC OXIDE	KM7N50LOS6	IACT
SACCHARIN	FST467XS7D	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 172 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	FILM, SOLUBLE / ORAL	0.06 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE, EXTENDED RELEASE / ORAL	0.03 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
MICROCRYSTALLINE WAX	MICROCRYSTALLINE WAX	XOF597Q3KY	GEL / TOPICAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / VAGINAL	0.05 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SHEA BUTTER	SHEA BUTTER	K49155WL9Y	LOTION / TOPICAL		2340 mg	Exact identifier — unii candidate
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET, FILM COATED / ORAL	15.29 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 16 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 16 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	POWDER, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	52 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	INJECTION / INTRAMUSCULAR		885 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
LECITHIN, SOYBEAN	SOYBEAN LECITHIN	1DI56QDM62	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.1 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	CREAM / TOPICAL	54.5 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET / SUBLINGUAL	1.6 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SPRAY / TOPICAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GEL, METERED / TOPICAL		4 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SOLUTION / ORAL	1.8 mg/120ml		Exact identifier — unii candidate 49 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	OINTMENT / TOPICAL	14.9 %w/w		Exact identifier — unii candidate 16 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	PASTE, DENTIFRICE / DENTAL	0.23 %w/w		Exact identifier — unii candidate 16 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	TABLET / ORAL	1.6 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	SOLUTION / ORAL		150 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	SYRUP / ORAL		8 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	JELLY / VAGINAL	42.6 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	GEL / NASAL		429 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	SOLUTION / TOPICAL	1.38 %w/w		Exact identifier — unii candidate 16 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL		7 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
LECITHIN, SOYBEAN	SOYBEAN LECITHIN	1DI56QDM62	TABLET, FILM COATED / ORAL	0.33 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	OINTMENT / TOPICAL	5 %w/w		Exact identifier — unii candidate 10 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	PASTE / DENTAL		60 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	LOTION / TOPICAL		20 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f0d2beaa-423a-4249-9e76-fc10fb872ccb			5006df08-636d-4633-991b-e2178369edaf	2011-09-12	Warnings	Exact identifier spl id: f0d2beaa-423a-4249-9e76-fc10fb872ccb spl set id: 5006df08-636d-4633-991b-e2178369edaf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.