SMASHBOX

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: 2011-05-27
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:28:07

Label at a glance#

ProductSMASHBOX CAMERA READY 5 IN 1 BEAUTY BALM SPF 35

Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE

Label structure5 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 4.00% [] OXYBENZONE 2.50% [] TITANIUM DIOXIDE 1.10%

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: WATER [] DIMETHICONE [] BUTYLENE GLYCOL [] PHENYL TRIMETHICONE [] PENTYLENE GLYCOL [] GLYCERYL STEARATE [] BEHENYL ALCOHOL [] TRIOCTYLDODECYL CITRATE [] POLYMETHYLSILSESQUIOXANE [] OCTYLDODECYL STEAROYL STEARATE [] PEG-40 STEARATE [] POLYGLYCERYL-10 PENTASTEARATE [] AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] HORDEUM VULGARE (BARLEY) EXTRACT [] CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT [] LAMINARIA SACCHARINA EXTRACT [] PYRUS MALUS (APPLE) FRUIT EXTRACT [] SCUTELLARIA BAICALENSIS ROOT EXTRACT [] POLYQUATERNIUM-51 [] ACETYL HEXAPEPTIDE-8 [] TREHALOSE [] ORYZANOL [] OCTYLDODECYL NEOPENTANOATE [] UREA [] POLYGLYCERYL-6 POLYRICINOLEATE [] PROPYLENE GLYCOL LAURATE [] GLYCYRRHETINIC ACID [] TOCOPHERYL ACETATE [] SUCROSE [] GLYCERIN [] SODIUM STEAROYL LACTYLATE [] CAFFEINE [] LINOLEIC ACID [] CHOLESTEROL [] LECITHIN [] SQUALANE [] SODIUM PCA [] ISOPROPYL TITANIUM TRIISOSTEARATE [] PROPYLENE GLYCOL STEARATE [] STEARIC ACID [] POLYSORBATE 20 [] SORBITAN LAURATE [] XANTHAN GUM [] ALUMINUM HYDROXIDE [] SODIUM HYALURONATE [] SILICA [] DISODIUM EDTA [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] SODIUM DEHYDROACETATE [] CHLORPHENESIN [] PHENOXYETHANOL [] [+/- TITANIUM DIOXIDE (CI 77891) [] ZINC OXIDE (CI 77947) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] MICA

WARNINGS SECTION

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL:

SMASHBOX CAMERA READY

5 IN 1

BEAUTY BALM

SPF 35

1.0 FL OZ/ 30 ML

MAKE-UP ART COSMETICS, DISTRIBUTOR
Smashbox Beauty Cosmetics Inc.

made in canada

folding carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
40046-0043-1	2019-10-29	C162847	48780-1	960f7f55-cc4a-8e05-e053-dbdaa90a074a	8bb7d802-f1b3-4adc-ba94-515c73261632

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
40046-0043-1	SMASHBOX CAMERA READY 5 IN 1 BEAUTY BALM SPF 35	1 in 1 CARTON	LIQUID	1		1
40046-0043-2	SMASHBOX CAMERA READY 5 IN 1 BEAUTY BALM SPF 35	30 mL in 1 TUBE	LIQUID	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
40046-0043	SMASHBOX (OCTINOXLATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE) LIQUID [MAKEUP ART COSMETICS]	1	Legacy NDC, 2 package rows	20110531_8bb7d802-f1b3-4adc-ba94-515c73261632.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	1
ACETYL HEXAPEPTIDE-3	INACTIVE INGREDIENT	L4EL31FWIL	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	1
APPLE	INACTIVE INGREDIENT	B423VGH5S9	1
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	1
CAFFEINE	INACTIVE INGREDIENT	3G6A5W338E	1
CHLORPHENESIN	INACTIVE INGREDIENT	I670DAL4SZ	1
CHOLESTEROL	INACTIVE INGREDIENT	97C5T2UQ7J	1
CUCUMBER	INACTIVE INGREDIENT	YY7C30VXJT	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
DOCOSANOL	INACTIVE INGREDIENT	9G1OE216XY	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
GAMMA ORYZANOL	INACTIVE INGREDIENT	SST9XCL51M	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	1
LINOLEIC ACID	INACTIVE INGREDIENT	9KJL21T0QJ	1
MICA	INACTIVE INGREDIENT	V8A1AW0880	1
OCTYLDODECYL NEOPENTANOATE	INACTIVE INGREDIENT	X8725R883T	1
OCTYLDODECYL STEAROYL STEARATE	INACTIVE INGREDIENT	3D47Q6D93C	1
PEG-40 STEARATE	INACTIVE INGREDIENT	ECU18C66Q7	1
PENTYLENE GLYCOL	INACTIVE INGREDIENT	50C1307PZG	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
PHENYL TRIMETHICONE	INACTIVE INGREDIENT	DR0K5NOJ4R	1
POLYMETHYLSILSESQUIOXANE (11 MICRONS)	INACTIVE INGREDIENT	Z570VEV8XK	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	1
PROPYLENE GLYCOL MONOLAURATE	INACTIVE INGREDIENT	M4AW13H75T	1
PROPYLENE GLYCOL MONOSTEARATE	INACTIVE INGREDIENT	F76354LMGR	1
SACCHARINA LATISSIMA	INACTIVE INGREDIENT	RTR3OGP8ET	1
SCUTELLARIA BAICALENSIS ROOT	INACTIVE INGREDIENT	7J95K7ID2S	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM DEHYDROACETATE	INACTIVE INGREDIENT	8W46YN971G	1
SODIUM PYRROLIDONE CARBOXYLATE	INACTIVE INGREDIENT	469OTG57A2	1
SORBITAN MONOLAURATE	INACTIVE INGREDIENT	6W9PS8B71J	1
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	1
TREHALOSE	INACTIVE INGREDIENT	B8WCK70T7I	1
UREA	INACTIVE INGREDIENT	8W8T17847W	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1
WHEAT GERM	INACTIVE INGREDIENT	YR3G369F5A	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	1

Products#

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

DailyMed product names page 1 of 2 · 49 matching rows.

SMASHBOX CAMERA READY 5 IN 1 BEAUTY BALM SPF 35
OCTINOXlATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
OCTINOXATE
OCTISALATE
OXYBENZONE
TITANIUM DIOXIDE
WATER
DIMETHICONE
BUTYLENE GLYCOL
PHENYL TRIMETHICONE
PENTYLENE GLYCOL
GLYCERYL MONOSTEARATE
DOCOSANOL
POLYMETHYLSILSESQUIOXANE (11 MICRONS)
OCTYLDODECYL STEAROYL STEARATE
PEG-40 STEARATE
WHEAT GERM
CUCUMBER
SACCHARINA LATISSIMA
APPLE
SCUTELLARIA BAICALENSIS ROOT
ACETYL HEXAPEPTIDE-3
TREHALOSE
GAMMA ORYZANOL
OCTYLDODECYL NEOPENTANOATE
UREA
PROPYLENE GLYCOL MONOLAURATE
ALPHA-TOCOPHEROL ACETATE
SUCROSE
GLYCERIN
CAFFEINE
LINOLEIC ACID
CHOLESTEROL
LECITHIN, SOYBEAN
SQUALANE
SODIUM PYRROLIDONE CARBOXYLATE
PROPYLENE GLYCOL MONOSTEARATE
STEARIC ACID
POLYSORBATE 20
SORBITAN MONOLAURATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
40046-0043	40046-0043-2, 40046-0043-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 47 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
WATER	059QF0KO0R	IACT
DIMETHICONE	92RU3N3Y1O	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
PHENYL TRIMETHICONE	DR0K5NOJ4R	IACT
PENTYLENE GLYCOL	50C1307PZG	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
DOCOSANOL	9G1OE216XY	IACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)	Z570VEV8XK	IACT
OCTYLDODECYL STEAROYL STEARATE	3D47Q6D93C	IACT
PEG-40 STEARATE	ECU18C66Q7	IACT
WHEAT GERM	YR3G369F5A	IACT
CUCUMBER	YY7C30VXJT	IACT
SACCHARINA LATISSIMA	RTR3OGP8ET	IACT
APPLE	B423VGH5S9	IACT
SCUTELLARIA BAICALENSIS ROOT	7J95K7ID2S	IACT
ACETYL HEXAPEPTIDE-3	L4EL31FWIL	IACT
TREHALOSE	B8WCK70T7I	IACT
GAMMA ORYZANOL	SST9XCL51M	IACT
OCTYLDODECYL NEOPENTANOATE	X8725R883T	IACT
UREA	8W8T17847W	IACT
PROPYLENE GLYCOL MONOLAURATE	M4AW13H75T	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
SUCROSE	C151H8M554	IACT
GLYCERIN	PDC6A3C0OX	IACT
CAFFEINE	3G6A5W338E	IACT
LINOLEIC ACID	9KJL21T0QJ	IACT
CHOLESTEROL	97C5T2UQ7J	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
SQUALANE	GW89575KF9	IACT
SODIUM PYRROLIDONE CARBOXYLATE	469OTG57A2	IACT
PROPYLENE GLYCOL MONOSTEARATE	F76354LMGR	IACT
STEARIC ACID	4ELV7Z65AP	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
SORBITAN MONOLAURATE	6W9PS8B71J	IACT
XANTHAN GUM	TTV12P4NEE	IACT
ALUMINUM HYDROXIDE	5QB0T2IUN0	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 · 370 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRADERMAL	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	LOZENGE / ORAL		1264 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SOLUTION / RECTAL	35.42 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	SOAP / TOPICAL	6 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, EXTENDED RELEASE / ORAL		529 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE / ORAL		254 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE / ORAL	13.75 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
DOCOSANOL	DOCOSANOL	9G1OE216XY	AEROSOL, FOAM / TOPICAL	1.1 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CREAM / TOPICAL		108 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
HYALURONATE SODIUM	HYALURONATE SODIUM	YSE9PPT4TH	LOTION / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SORBITAN MONOLAURATE	SORBITAN MONOLAURATE	6W9PS8B71J	SPRAY, METERED / NASAL		1 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, CHEWABLE / ORAL		2 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SUSPENSION / ORAL		600 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SORBITAN MONOLAURATE	SORBITAN MONOLAURATE	6W9PS8B71J	CREAM / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, LIQUID FILLED / ORAL		185 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CHOLESTEROL	CHOLESTEROL	97C5T2UQ7J	INJECTABLE, LIPOSOMAL / INTRAVENOUS		437 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	TABLET / ORAL		17 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
HYALURONATE SODIUM	HYALURONATE SODIUM	YSE9PPT4TH	INJECTION, SUSPENSION / INTRAVITREAL		23 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
LECITHIN, SOYBEAN	SOYBEAN LECITHIN	1DI56QDM62	CAPSULE / ORAL	20 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SORBITAN MONOLAURATE	SORBITAN MONOLAURATE	6W9PS8B71J	TABLET, FILM COATED / ORAL		800 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 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
ALUMINUM HYDROXIDE	ALUMINUM HYDROXIDE	5QB0T2IUN0	TABLET / ORAL	50 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, FILM COATED / ORAL	0.08 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	GEL / TOPICAL	5 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
CAFFEINE	CAFFEINE	3G6A5W338E	SOLUTION / OPHTHALMIC	2 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER / ORAL	275 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
CAFFEINE	CAFFEINE	3G6A5W338E	GRANULE / ORAL	NA		Exact identifier — unii candidate 3 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SORBITAN MONOLAURATE	SORBITAN MONOLAURATE	6W9PS8B71J	SUSPENSION / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 12 equally ranked IID candidates
SORBITAN MONOLAURATE	SORBITAN MONOLAURATE	6W9PS8B71J	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		15 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, EXTENDED RELEASE / ORAL		528 mg	Exact identifier — unii candidate 29 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
91e3d67c-7165-4b28-9971-eea8e344c183			8bb7d802-f1b3-4adc-ba94-515c73261632	2011-05-27	Warnings	Exact identifier spl id: 91e3d67c-7165-4b28-9971-eea8e344c183 spl set id: 8bb7d802-f1b3-4adc-ba94-515c73261632

Reported adverse events (FAERS/openFDA)#

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