TENDERTONE LIP BALM SPF 12

Manufacturer: MAKEUP ART COSMETICS | ELGC Kabushiki Kaisha | Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) | ARAMIS, INC | ESTEE LAUDER COSMETICS DISTRIBUTION CENTER | ESTEE LAUDER COSMETICS, LTD | ESTEE LAUDER COSMETICS, LTD. | ESTEE LAUDER N.V. | LEN-RON MANUFACTURING DIVISION OF ARAMIS INC | NORTEC KEYSTONE | NORTHTEC BRISTOL | NORTHTEC KEYSTONE | WHITMAN LABORATORIES, LTD. | Aveda Corporation
Effective date: 2012-01-17
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:30:36

Label at a glance#

ProductTENDERTONE LIP BALM SPF 12

Active ingredientOCTINOXATE, OCTISALATE, AVOBENZONE

Label structure5 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE 7.50%, OCTISALATE 2.00%, AVOBENZONE 1.50%

WARNING

WARNINGS SECTION

OTC - STOP USE SECTION

STOP USE IF IRRITATION OCCURS.

INGREDIENTS

INACTIVE INGREDIENT SECTION

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>

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 6 ML Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAC

TENDERTONE
LIP BALM SPF 12

6 ML/0.2 US FL OZ e

PRINCIPAL DISPLAY PANEL - 6 ML Jar Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
40046-0030-1	2019-11-13	C162847	48780-1	97449f38-c0d1-f6ea-e053-dbdaa90aa703	MAC TENDERTONE LIP BALM SPF 12

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
40046-0030-1	TENDERTONE LIP BALM SPF 12	1 in 1 CARTON	LIPSTICK	1		1
40046-0030-1	TENDERTONE LIP BALM SPF 12	6 mL in 1 JAR	LIPSTICK	6		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
40046-0030	TENDERTONE LIP BALM SPF 12 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) LIPSTICK [MAKEUP ART COSMETICS]	1	Legacy NDC, 2 package rows	20120118_f75ccb8e-9947-4921-9dc7-20816dee7372.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	1
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	1
Alpha-Tocopherol Acetate	INACTIVE INGREDIENT	9E8X80D2L0	1
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	1
Arabica Coffee Bean	INACTIVE INGREDIENT	3SW678MX72	1
Astrocaryum Murumuru Seed Butter	INACTIVE INGREDIENT	12V64UPU6R	1
Bismuth Oxychloride	INACTIVE INGREDIENT	4ZR792I587	1
Black Olive	INACTIVE INGREDIENT	2M6QWV94OC	1
Butylated Hydroxytoluene	INACTIVE INGREDIENT	1P9D0Z171K	1
Caprylyl Glycol	INACTIVE INGREDIENT	00YIU5438U	1
Cholesterol	INACTIVE INGREDIENT	97C5T2UQ7J	1
Cochineal	INACTIVE INGREDIENT	TZ8Z31B35M	1
D&C Red No. 28	INACTIVE INGREDIENT	767IP0Y5NH	1
D&C Red No. 30	INACTIVE INGREDIENT	2S42T2808B	1
D&C Red No. 33	INACTIVE INGREDIENT	9DBA0SBB0L	1
D&C Red No. 6	INACTIVE INGREDIENT	481744AI4O	1
D&C Red No. 7	INACTIVE INGREDIENT	ECW0LZ41X8	1
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
Ethylcelluloses	INACTIVE INGREDIENT	7Z8S9VYZ4B	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C Yellow No. 5	INACTIVE INGREDIENT	I753WB2F1M	1
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	1
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	1
Ferrosoferric Oxide	INACTIVE INGREDIENT	XM0M87F357	1
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	1
Hexylene Glycol	INACTIVE INGREDIENT	KEH0A3F75J	1
Linoleic Acid	INACTIVE INGREDIENT	9KJL21T0QJ	1
Mica	INACTIVE INGREDIENT	V8A1AW0880	1
Octyldodecanol	INACTIVE INGREDIENT	461N1O614Y	1
Oleic Acid	INACTIVE INGREDIENT	2UMI9U37CP	1
Palmitic Acid	INACTIVE INGREDIENT	2V16EO95H1	1
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	1
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	1
Potassium Sulfate	INACTIVE INGREDIENT	1K573LC5TV	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
Stannic Oxide	INACTIVE INGREDIENT	KM7N50LOS6	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1
Wheat Bran	INACTIVE INGREDIENT	6L966A1IMR	1

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

TENDERTONE LIP BALM SPF 12
OCTINOXATE, OCTISALATE, and AVOBENZONE
OCTINOXATE
OCTISALATE
AVOBENZONE
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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
40046-0030	40046-0030-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
AVOBENZONE	G63QQF2NOX	ACTIB
Petrolatum	4T6H12BN9U	IACT
Astrocaryum Murumuru Seed Butter	12V64UPU6R	IACT
Arabica Coffee Bean	3SW678MX72	IACT
Black Olive	2M6QWV94OC	IACT
Wheat Bran	6L966A1IMR	IACT
Alpha-Tocopherol Acetate	9E8X80D2L0	IACT
Water	059QF0KO0R	IACT
Ethylcelluloses	7Z8S9VYZ4B	IACT
Cholesterol	97C5T2UQ7J	IACT
Octyldodecanol	461N1O614Y	IACT
Caprylyl Glycol	00YIU5438U	IACT
Glyceryl Monostearate	230OU9XXE4	IACT
Linoleic Acid	9KJL21T0QJ	IACT
Oleic Acid	2UMI9U37CP	IACT
Palmitic Acid	2V16EO95H1	IACT
Potassium Sulfate	1K573LC5TV	IACT
Silicon Dioxide	ETJ7Z6XBU4	IACT
Aluminum Oxide	LMI26O6933	IACT
Stannic Oxide	KM7N50LOS6	IACT
Hexylene Glycol	KEH0A3F75J	IACT
Butylated Hydroxytoluene	1P9D0Z171K	IACT
Phenoxyethanol	HIE492ZZ3T	IACT
Mica	V8A1AW0880	IACT
Titanium Dioxide	15FIX9V2JP	IACT
Ferric Oxide Red	1K09F3G675	IACT
Ferric Oxide Yellow	EX438O2MRT	IACT
Ferrosoferric Oxide	XM0M87F357	IACT
Bismuth Oxychloride	4ZR792I587	IACT
FD&C Blue No. 1	H3R47K3TBD	IACT
Cochineal	TZ8Z31B35M	IACT
D&C Red No. 6	481744AI4O	IACT
D&C Red No. 7	ECW0LZ41X8	IACT
D&C Red No. 28	767IP0Y5NH	IACT
D&C Red No. 30	2S42T2808B	IACT
D&C Red No. 33	9DBA0SBB0L	IACT
FD&C Yellow No. 5	I753WB2F1M	IACT
D&C Yellow No. 10	35SW5USQ3G	IACT

Source Document#

Source XML

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 7 · 402 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
D&C Red No. 28	D&C RED NO. 28	767IP0Y5NH	POWDER, FOR SUSPENSION / ORAL	0.7 mg/5ml		Exact identifier — unii candidate 11 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / RECTAL		1 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	3.6 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
D&C Red No. 33	D&C RED NO. 33	9DBA0SBB0L	SUSPENSION / ORAL	0.13 mg/5ml		Exact identifier — unii candidate 14 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Hexylene Glycol	HEXYLENE GLYCOL	KEH0A3F75J	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
Cholesterol	CHOLESTEROL	97C5T2UQ7J	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	0.32 %w/v		Exact identifier — unii candidate 10 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE / ORAL	13.75 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CREAM / VAGINAL		51 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Cholesterol	CHOLESTEROL	97C5T2UQ7J	CREAM / VAGINAL	0.3 %w/w		Exact identifier — unii candidate 10 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
D&C Red No. 33	D&C RED NO. 33	9DBA0SBB0L	TABLET / ORAL	0.24 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	DROPS / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
Ferrosoferric Oxide	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	SOLUTION / ORAL		8 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, FILM COATED / ORAL	0.16 mg		Exact identifier — unii candidate 37 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
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
D&C Red No. 28	D&C RED NO. 28	767IP0Y5NH	TABLET / ORAL	NA		Exact identifier — unii candidate 11 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
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
D&C Red No. 33	D&C RED NO. 33	9DBA0SBB0L	SHAMPOO / TOPICAL	NA		Exact identifier — unii candidate 14 equally ranked IID candidates
Palmitic Acid	PALMITIC ACID	2V16EO95H1	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, DELAYED RELEASE / ORAL	1.9 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE / ORAL	26.3 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	SHAMPOO / TOPICAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	POWDER, FOR SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / ORAL		14 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, LIQUID FILLED / ORAL	1.51 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	FILM, SOLUBLE / ORAL	0.06 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
Ferric Oxide Yellow	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, FILM COATED / ORAL		6 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Ferric Oxide Red	FERRIC OXIDE RED	1K09F3G675	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	POWDER / ORAL		48 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET / ORAL	27.53 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
Ferric Oxide Yellow	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, CHEWABLE / ORAL		14 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION, CONCENTRATE / ORAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, CHEWABLE / ORAL	4.5 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	CREAM / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 37 equally ranked IID candidates
D&C Yellow No. 10	D&C YELLOW NO. 10	35SW5USQ3G	GUM, CHEWING / BUCCAL		24 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
Butylated Hydroxytoluene	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / SUBLINGUAL	0.13 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
D&C Red No. 33	D&C RED NO. 33	9DBA0SBB0L	SOLUTION / ORAL		2 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
Titanium Dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 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
55e576e5-b615-429a-90f5-f741d3d48209			f75ccb8e-9947-4921-9dc7-20816dee7372	2012-01-17	Warnings	Exact identifier spl id: 55e576e5-b615-429a-90f5-f741d3d48209 spl set id: f75ccb8e-9947-4921-9dc7-20816dee7372

Reported adverse events (FAERS/openFDA)#

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