TITANIUM DIOXIDE

Manufacturer: Kosan Kozmetik Sanayi ve Ticaret A.S.
Effective date: 2019-10-18
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 23:01:09

Label at a glance#

Productflormar Delicious Lipstick Stylo Sunscreen Broad Spectrum SPF 15 DS03 Doll Photomontage

Active ingredientTITANIUM DIOXIDE

Label structure8 sections

Dosage and administration

Apply on the center of the lips and blend Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially f...

Contacts and useful links#

Websitewww.flormar.com

WWW.FLORMAR.COM

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titaniuim Dioxide 2%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

Helps prevent sunburn
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Directions

DOSAGE & ADMINISTRATION SECTION

Apply on the center of the lips and blend
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10 a.m. - 2 p.m.
Wear long-sleeved shirts, pants, hats and sunglasses

Other information

SPL UNCLASSIFIED SECTION

Protect this product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

DIISOSTEARYL MALATE, TRIDECYL TRIMELLIATATE, CASTOR (RICINUS COMMUNIS (CASTOR) SEED OIL, POLYETHYLENE, OCTYLDODECANOL,
HYDROGENATED POLYDECENE, PHENYL TRIMETHICONE, MICROCRYSTALLINE WAX, SILICA, MICA, BIS-DIGLYCERYL POLYACYLADIPATE-2, TRIISOSTEARYL CITRATE, CANDELILLA (EUPHORBIA CERIFERA) WAX, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PENTAERTHRITYL TETRABEHENATE, POLYMETHYL METHACRYLATE, POLYBUTENE, SHEA (BUTYROSPERMUM PARKII) BUTTER, COCOA (THEOBROMA CACAO) SEED BUTTER, CAPRYLIC/CAPRIC TRIGLYCERIDE, LAUROYL LYSINE, FRAGRANCE, PEG-8, PENTAERTHRITYL TETRA-DI-T-BUTYL
HYDROXYHDROCINNAMATE, TOCOPHEROL, ORCHID (CYMBIDIUM GRANIFLORUM) FLOWER EXTRACT, ASCORBYL PALMITATE, ASCORBIC ACID, CITRIC ACID, D& C RED NO. 28 ALUMINUM LAKE.

KOSAN KOZMETIK SANAYI VE TICARET A.S.

SPL UNCLASSIFIED SECTION

GEBZE ORGANIZE SANAYI BOLGESI IHSAN DEDE CAD.900.SK NO:133 GEBZE, KOCAELI 41480 TURKEY
MADE IN TURKEY
WWW.FLORMAR.COM
TO REPORT A SERIOUS ADVERSE EVENT
CONTACT [971] 766 – 7350. WITH ULTRA-RICH AND INTENSE COLOR, THIS SPF 15 SUNSCREEN LIPSTICK LEAVES THE LIPS FEELING
COMFORTABLE. EXPERIENCE THIS CREAMY TEXTURE AND HIGH COMFORT. APPLY ON THE CENTER OF THE LIPS AND BLEND.

Product Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

flormar Delicious Lipstick Style Sunscreen Broad Spectrum SPF 15 Net Wt. 0.11 oz (3g)

flormarLipstikc_Outer

flormarLipstikc_Inner

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61722-230-00	2021-01-29	C162847	48780-1	ba0f9c33-3e46-a910-e053-dadaa90a0b85	flormar Delicious Lipstick Stylo Sunscreen Broad Spectrum SPF 15 DS03 Doll Photomontage

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61722-230-00	flormar Delicious Lipstick Stylo Sunscreen Broad Spectrum SPF 15 DS03 Doll Photomontage	1 in 1 BOX	STICK	1		4
61722-230-00	flormar Delicious Lipstick Stylo Sunscreen Broad Spectrum SPF 15 DS03 Doll Photomontage	3 g in 1 TUBE	STICK	3		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61722-230	FLORMAR DELICIOUS LIPSTICK STYLO SUNSCREEN BROAD SPECTRUM SPF 15 DS03 DOLL PHOTOMONTAGE (TITANIUM DIOXIDE) STICK [KOSAN KOZMETIK SANAYI VE TICARET A.S.]	4	Legacy NDC, 2 package rows	20191019_ac7450c7-a3c5-4c7f-ab33-780abd1ecc63.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	2
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	2
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	2
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	2
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	2
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	2
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	2
DIISOSTEARYL MALATE	INACTIVE INGREDIENT	QBS8A3XZGQ	2
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	2
LAUROYL LYSINE	INACTIVE INGREDIENT	113171Q70B	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	2
MICA	INACTIVE INGREDIENT	V8A1AW0880	2
MICROCRYSTALLINE WAX	INACTIVE INGREDIENT	XOF597Q3KY	2
OCTYLDODECANOL	INACTIVE INGREDIENT	461N1O614Y	2
PENTAERYTHRITYL TETRABEHENATE	INACTIVE INGREDIENT	9MNZ044IRY	2
PHENYL TRIMETHICONE	INACTIVE INGREDIENT	DR0K5NOJ4R	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	2
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	2
TRIDECYL TRIMELLITATE	INACTIVE INGREDIENT	FY36J270ES	2
TRIISOSTEARYL CITRATE	INACTIVE INGREDIENT	50XT325OOH	2

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

flormar Delicious Lipstick Stylo Sunscreen Broad Spectrum SPF 15 DS03 Doll Photomontage
TITANIUM DIOXIDE
DIISOSTEARYL MALATE
TRIDECYL TRIMELLITATE
CASTOR OIL
HIGH DENSITY POLYETHYLENE
OCTYLDODECANOL
PHENYL TRIMETHICONE
MICROCRYSTALLINE WAX
SILICON DIOXIDE
MICA
TRIISOSTEARYL CITRATE
CANDELILLA WAX
PENTAERYTHRITYL TETRABEHENATE
SHEA BUTTER
COCOA BUTTER
MEDIUM-CHAIN TRIGLYCERIDES
LAUROYL LYSINE
POLYETHYLENE GLYCOL 400
TOCOPHEROL
ASCORBYL PALMITATE
ASCORBIC ACID
CITRIC ACID MONOHYDRATE
D&C RED NO. 28

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61722-230	61722-230-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIISOSTEARYL MALATE	QBS8A3XZGQ	IACT
TRIDECYL TRIMELLITATE	FY36J270ES	IACT
CASTOR OIL	D5340Y2I9G	IACT
HIGH DENSITY POLYETHYLENE	UG00KM4WR7	IACT
OCTYLDODECANOL	461N1O614Y	IACT
PHENYL TRIMETHICONE	DR0K5NOJ4R	IACT
MICROCRYSTALLINE WAX	XOF597Q3KY	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
MICA	V8A1AW0880	IACT
TRIISOSTEARYL CITRATE	50XT325OOH	IACT
CANDELILLA WAX	WL0328HX19	IACT
PENTAERYTHRITYL TETRABEHENATE	9MNZ044IRY	IACT
SHEA BUTTER	K49155WL9Y	IACT
COCOA BUTTER	512OYT1CRR	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
LAUROYL LYSINE	113171Q70B	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
TOCOPHEROL	R0ZB2556P8	IACT
ASCORBYL PALMITATE	QN83US2B0N	IACT
ASCORBIC ACID	PQ6CK8PD0R	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
D&C RED NO. 28	767IP0Y5NH	IACT
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB

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 5 · 291 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET / ORAL		4 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE / ORAL		13440 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION, SOLUTION / INTRAVENOUS		24186 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SYRUP / ORAL		740 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER / ORAL		840 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET, EXTENDED RELEASE / ORAL	0.64 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	SUPPOSITORY / RECTAL	3 mg		Exact identifier — unii candidate 25 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	SUSPENSION, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	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
CASTOR OIL	CASTOR OIL	D5340Y2I9G	CAPSULE / ORAL	1.04 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	SOLUTION / ORAL		600 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	EMULSION / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 36 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
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION/ DROPS / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii candidate 25 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SWAB / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET / ORAL	914 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	OINTMENT / OPHTHALMIC	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 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
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / ORAL		70200 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAMUSCULAR		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	GRANULE, FOR SUSPENSION / ORAL		128 mg	Exact identifier — unii candidate 16 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, EXTENDED RELEASE / ORAL		17 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / TOPICAL	0.01 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	OINTMENT / TOPICAL		1950 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	CREAM / TOPICAL		160 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / SUBCUTANEOUS		26 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	AEROSOL, FOAM / RECTAL		7 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	AEROSOL, FOAM / TOPICAL	10.87 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SPRAY / TOPICAL		540 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
D&C RED NO. 28	D&C RED NO. 28	767IP0Y5NH	CAPSULE, EXTENDED RELEASE / ORAL	0.2 mg		Exact identifier — unii candidate 11 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
CASTOR OIL	CASTOR OIL	D5340Y2I9G	TABLET / SUBLINGUAL	1.6 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE PARTICLES / ORAL		170 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	INJECTION, SOLUTION / INTRAVENOUS		4 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
CASTOR OIL	CASTOR OIL	D5340Y2I9G	SPRAY / NASAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	2 mg		Exact identifier — unii candidate 25 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	TABLET, DELAYED RELEASE / ORAL		35 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.1 %w/w		Exact identifier — unii candidate 25 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION / INTRAVENOUS		28216 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
OCTYLDODECANOL	OCTYLDODECANOL	461N1O614Y	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 9 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
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUPPOSITORY / RECTAL	0.25 mg/mg		Exact identifier — unii candidate 36 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 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
952f869c-89f8-4958-e053-2995a90a0d5d			ac7450c7-a3c5-4c7f-ab33-780abd1ecc63	2019-10-18	Warnings	Exact identifier spl id: 952f869c-89f8-4958-e053-2995a90a0d5d spl set id: ac7450c7-a3c5-4c7f-ab33-780abd1ecc63

Reported adverse events (FAERS/openFDA)#

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