AVOBENZONE, OCTINOXATE, OCTISALATE

Manufacturer: Laura Geller Beauty, LLC | MANA Products, Inc.
Effective date: 2014-03-10
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:38:40

Label at a glance#

ProductLAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER MEDIUM

Active ingredientAVOBENZONE, OCTINOXATE, OCTISALATE

Label structure8 sections

Indications and uses

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.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. 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, especi...

Storage and handling

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

Label contents#

Full prescribing information#

LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER MEDIUM

SPL UNCLASSIFIED SECTION

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.00%
Octinoxate 7.50%
Octisalate 5.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

USES

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

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure.
Use a water resistant sunscreen if swimming or sweating.
Reapply at least every 2 hours.
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.
Children under 6 months of age: Ask a doctor.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Mica, Octyldodecyl Neopentanoate, Butylene Glycol, Cyclopentsiloxane, Titanium Dioxide (CI 77891), Dimethicone, Camellia Sinensis Leaf Extract, Ginkgo Biloba Leaf Extract, Aloe Barbadensis Leaf Extract, Hamamelis Virginia (Witch Hazel) Water, Centella Asiatica Extract, Lens Esculenta (Lentil) Seed Extract, Dimethiconol, Glyceryl Acrylate/Acrylic Acid Copolymer, PEG/PPG-18 Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 1,2-Hexandiol, Decylene Glycol, Sodium Hydroxide, Disodium EDTA, Phenoxyethanol, Iron Oxides (CI 77491, CI 77492, CI 77499).

Other Information

STORAGE AND HANDLING SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call Laura Gellar Beauty, LLC, 1 (800) MAKE UP4

LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER MEDIUM 59ml (51389-202-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51389-202-00	2020-01-31	C162847	48780-1	9d75b9d0-faa8-f424-e053-dadaa90a57ce	LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER MEDIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51389-202-00	LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER MEDIUM	1 in 1 PACKAGE	CREAM	1		2
51389-202-00	LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER MEDIUM	59 mL in 1 TUBE	CREAM	59		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51389-202	LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER MEDIUM (AVOBENZONE, OCTINOXATE, OCTISALATE) CREAM [LAURA GELLER BEAUTY, LLC]	2	Legacy NDC, 2 package rows	20140310_799d919c-9c42-4f09-8450-47da4cd4bc10.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	2
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	2
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	2
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	2
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	2
1,2-HEXANEDIOL	INACTIVE INGREDIENT	TR046Y3K1G	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	2
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	2
CENTELLA ASIATICA	INACTIVE INGREDIENT	7M867G6T1U	2
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	2
DECYLENE GLYCOL	INACTIVE INGREDIENT	S57M60MI88	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	2
GINKGO	INACTIVE INGREDIENT	19FUJ2C58T	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	2
HAMAMELIS VIRGINIANA TOP WATER	INACTIVE INGREDIENT	NT00Y05A2V	2
LENTIL	INACTIVE INGREDIENT	6O38V6B52O	2
MICA	INACTIVE INGREDIENT	V8A1AW0880	2
OCTYLDODECYL NEOPENTANOATE	INACTIVE INGREDIENT	X8725R883T	2
PEG/PPG-18/18 DIMETHICONE	INACTIVE INGREDIENT	9H0AO7T794	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER MEDIUM
AVOBENZONE, OCTINOXATE, OCTISALATE
AVOBENZONE
OCTINOXATE
OCTISALATE
WATER
GLYCERIN
MICA
OCTYLDODECYL NEOPENTANOATE
BUTYLENE GLYCOL
CYCLOMETHICONE 5
TITANIUM DIOXIDE
DIMETHICONE
GREEN TEA LEAF
GINKGO
ALOE VERA LEAF
HAMAMELIS VIRGINIANA TOP WATER
CENTELLA ASIATICA
LENTIL
PEG/PPG-18/18 DIMETHICONE
1,2-HEXANEDIOL
DECYLENE GLYCOL
SODIUM HYDROXIDE
EDETATE DISODIUM
PHENOXYETHANOL
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51389-202	51389-202-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AVOBENZONE	G63QQF2NOX	ACTIB
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
MICA	V8A1AW0880	IACT
OCTYLDODECYL NEOPENTANOATE	X8725R883T	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
CYCLOMETHICONE 5	0THT5PCI0R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
DIMETHICONE	92RU3N3Y1O	IACT
GREEN TEA LEAF	W2ZU1RY8B0	IACT
GINKGO	19FUJ2C58T	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
HAMAMELIS VIRGINIANA TOP WATER	NT00Y05A2V	IACT
CENTELLA ASIATICA	7M867G6T1U	IACT
LENTIL	6O38V6B52O	IACT
PEG/PPG-18/18 DIMETHICONE	9H0AO7T794	IACT
1,2-HEXANEDIOL	TR046Y3K1G	IACT
DECYLENE GLYCOL	S57M60MI88	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
FERROSOFERRIC OXIDE	XM0M87F357	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 8 · 430 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SWAB / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / NASAL	100 mg/100ml		Exact identifier — unii candidate 77 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 20 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
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	SUSPENSION, EXTENDED RELEASE / ORAL	2.7 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAVENOUS	2.78 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL / TRANSDERMAL		472 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / PERIODONTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	EMULSION / INTRAVENOUS	2.2 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SHAMPOO / TOPICAL		3 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL		232 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 20 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
GLYCERIN	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	POWDER / RESPIRATORY (INHALATION)	0.04 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, DELAYED RELEASE / ORAL		14 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / ORAL		24 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / RESPIRATORY (INHALATION)	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	5.4 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR	0.35 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / ORAL	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, DELAYED RELEASE / ORAL	0.25 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SUBMUCOSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	EMULSION / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / SUBCUTANEOUS	1 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / URETHRAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION, CONCENTRATE / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CREAM, AUGMENTED / TOPICAL		6 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	136.55 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / URETERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, DELAYED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, EXTENDED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, EMULSION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, DELAYED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii candidate 75 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
7b64863e-d932-482a-8379-2bd94644bac1			799d919c-9c42-4f09-8450-47da4cd4bc10	2014-03-10	Warnings	Exact identifier spl id: 7b64863e-d932-482a-8379-2bd94644bac1 spl set id: 799d919c-9c42-4f09-8450-47da4cd4bc10

Reported adverse events (FAERS/openFDA)#

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