PREP PLUS PRIME BB BEAUTY BALM COMPACT

Manufacturer: MAKEUP ART COSMETICS | ESTEE LAUDER COMPANY, THE | ESTEE LAUDER COSMETICS, LTD | ESTEE LAUDER COSMETICS, LTD. | ESTEE LAUDER N.V. | LEN-RON MANUFACTURING DIVISION OF ARAMIS INC | NORTHTEC INC | PADC 1 | WHITMAN LABORATORIES, LTD.
Effective date: 2018-12-20
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 00:38:59

Label at a glance#

ProductPREP PLUS PRIME BB BEAUTY BALM COMPACT BROAD SPECTRUM SPF 30

Active ingredientOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE

Label structure9 sections

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure reapply every two 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, ...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients	Purpose
Octinoxate 7.50%	Sunscreen
Octisalate 5.00%	Sunscreen
Titanium Dioxide 9.80%	Sunscreen
Zinc Oxide 6.30%	Sunscreen

Use

INDICATIONS & USAGE SECTION

helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

apply liberally 15 minutes before sun exposure
reapply every two 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 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-sleezed shirts, pants, hats and sunglasses
children under 6 months of age: ask a doctor

inactive ingredients

INACTIVE INGREDIENT SECTION

octyldodecyl neopentanoate, neopentyl glycol diheptanoate, polyethylene, butyloctyl salicylate, hdi/trimethylol hexyllactone crosspolymer, beeswax\cera alba\cire d'abeille, phenyl trimethicone, c12-15 alkyl benzoate, silica, polybutene, alumina, tocopherol, tocopheryl acetate, glycyrrhiza glabra (licorice) root extract, astrocaryum murumuru seed butter, santalum album seed extract, glycine soja (soybean) oil, elaeis guineensis (palm) oil, euphorbia cerifera (candelilla) wax\candelilla cera\cire de candelilla, hydrogenated cottonseed oil, sodium hyaluronate, squalene, cetyl dimethicone, phytosterols, tocotrienols, ethylhexyl palmitate, triethyl citrate, caprylyl methicone, bis-diglyceryl polyacyladipate-2, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-6 polyricinoleate, caprylyl glycol, butylene glycol, nylon-12, disteardimonium hectorite, triethoxycaprylylsilane, vp/eicosene copolymer, synthetic beeswax, allyl methacrylates crosspolymer, silica dimethyl silylate, lauric acid, isopropyl titanium triisostearate, dipentaerythrityl tri-polyhydroxystearate [+/- mica, titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499)] <iln39107>

Other information

STORAGE AND HANDLING SECTION

protect the product in this container from excessive heat and direct sun

SPL UNCLASSIFIED SECTION

DIST. BY/PAR: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7

PRINCIPAL DISPLAY PANEL - 8g Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

M•A•C
PREP+PRIME

BB
BEAUTY BALM
COMPACT SPF 30
BROAD SPECTRUM SPF 30

NET WT. / 8g / 0.28 US OZ e

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	1
.alpha.-tocopherol acetate	INACTIVE INGREDIENT	9E8X80D2L0	1
alkyl (c12-15) benzoate	INACTIVE INGREDIENT	A9EJ3J61HQ	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	1
astrocaryum murumuru seed butter	INACTIVE INGREDIENT	12V64UPU6R	1
butylene glycol	INACTIVE INGREDIENT	3XUS85K0RA	1
butyloctyl salicylate	INACTIVE INGREDIENT	2EH13UN8D3	1
candelilla wax	INACTIVE INGREDIENT	WL0328HX19	1
caprylyl glycol	INACTIVE INGREDIENT	00YIU5438U	1
caprylyl trisiloxane	INACTIVE INGREDIENT	Q95M2P1KJL	1
ethylhexyl palmitate	INACTIVE INGREDIENT	2865993309	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	1
glycyrrhiza glabra	INACTIVE INGREDIENT	2788Z9758H	1
high density polyethylene	INACTIVE INGREDIENT	UG00KM4WR7	1
hyaluronate sodium	INACTIVE INGREDIENT	YSE9PPT4TH	1
hydrogenated cottonseed oil	INACTIVE INGREDIENT	Z82Y2C65EA	1
isopropyl titanium triisostearate	INACTIVE INGREDIENT	949E3KBJ1I	1
lauric acid	INACTIVE INGREDIENT	1160N9NU9U	1
mica	INACTIVE INGREDIENT	V8A1AW0880	1
neopentyl glycol diheptanoate	INACTIVE INGREDIENT	5LKW3C543X	1
nylon-12	INACTIVE INGREDIENT	446U8J075B	1
octyldodecyl neopentanoate	INACTIVE INGREDIENT	X8725R883T	1
palm oil	INACTIVE INGREDIENT	5QUO05548Z	1
phenyl trimethicone	INACTIVE INGREDIENT	DR0K5NOJ4R	1
santalum album seed	INACTIVE INGREDIENT	7RZT0U509Y	1
silica dimethyl silylate	INACTIVE INGREDIENT	EU2PSP0G0W	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
soybean oil	INACTIVE INGREDIENT	241ATL177A	1
squalene	INACTIVE INGREDIENT	7QWM220FJH	1
tocopherol	INACTIVE INGREDIENT	R0ZB2556P8	1
tocotrienols	INACTIVE INGREDIENT	KP2MW85SSQ	1
triethoxycaprylylsilane	INACTIVE INGREDIENT	LDC331P08E	1
triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	1
yellow wax	INACTIVE INGREDIENT	2ZA36H0S2V	1

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

PREP PLUS PRIME BB BEAUTY BALM COMPACT BROAD SPECTRUM SPF 30
OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, and ZINC OXIDE
OCTINOXATE
OCTISALATE
TITANIUM DIOXIDE
ZINC OXIDE
octyldodecyl neopentanoate
neopentyl glycol diheptanoate
high density polyethylene
butyloctyl salicylate
yellow wax
phenyl trimethicone
alkyl (c12-15) benzoate
silicon dioxide
aluminum oxide
tocopherol
.alpha.-tocopherol acetate
glycyrrhiza glabra
astrocaryum murumuru seed butter
santalum album seed
soybean oil
palm oil
candelilla wax
hydrogenated cottonseed oil
hyaluronate sodium
squalene
tocotrienols
ethylhexyl palmitate
triethyl citrate
caprylyl trisiloxane
caprylyl glycol
butylene glycol
nylon-12
triethoxycaprylylsilane
silica dimethyl silylate
lauric acid
isopropyl titanium triisostearate
mica
ferric oxide red
ferric oxide yellow

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
40046-0062	40046-0062-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB
octyldodecyl neopentanoate	X8725R883T	IACT
neopentyl glycol diheptanoate	5LKW3C543X	IACT
high density polyethylene	UG00KM4WR7	IACT
butyloctyl salicylate	2EH13UN8D3	IACT
yellow wax	2ZA36H0S2V	IACT
phenyl trimethicone	DR0K5NOJ4R	IACT
alkyl (c12-15) benzoate	A9EJ3J61HQ	IACT
silicon dioxide	ETJ7Z6XBU4	IACT
aluminum oxide	LMI26O6933	IACT
tocopherol	R0ZB2556P8	IACT
.alpha.-tocopherol acetate	9E8X80D2L0	IACT
glycyrrhiza glabra	2788Z9758H	IACT
astrocaryum murumuru seed butter	12V64UPU6R	IACT
santalum album seed	7RZT0U509Y	IACT
soybean oil	241ATL177A	IACT
palm oil	5QUO05548Z	IACT
candelilla wax	WL0328HX19	IACT
hydrogenated cottonseed oil	Z82Y2C65EA	IACT
hyaluronate sodium	YSE9PPT4TH	IACT
squalene	7QWM220FJH	IACT
tocotrienols	KP2MW85SSQ	IACT
ethylhexyl palmitate	2865993309	IACT
triethyl citrate	8Z96QXD6UM	IACT
caprylyl trisiloxane	Q95M2P1KJL	IACT
caprylyl glycol	00YIU5438U	IACT
butylene glycol	3XUS85K0RA	IACT
nylon-12	446U8J075B	IACT
triethoxycaprylylsilane	LDC331P08E	IACT
silica dimethyl silylate	EU2PSP0G0W	IACT
lauric acid	1160N9NU9U	IACT
isopropyl titanium triisostearate	949E3KBJ1I	IACT
mica	V8A1AW0880	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 4 · 189 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	PASTE / DENTAL		60 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	TABLET / BUCCAL	0.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	LOTION / TOPICAL	NA		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
yellow wax	YELLOW WAX	2ZA36H0S2V	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
candelilla wax	CANDELILLA WAX	WL0328HX19	TABLET, EXTENDED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
yellow wax	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	DROPS / ORAL	NA		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
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET, EXTENDED RELEASE / ORAL	0.64 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	CAPSULE, COATED / ORAL	0.12 mg		Exact identifier — unii candidate 21 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
yellow wax	YELLOW WAX	2ZA36H0S2V	TABLET / ORAL	3.22 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
butylene glycol	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TOPICAL		1400 mg	Exact identifier — unii candidate 2 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
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, COATED / ORAL		176 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
triethyl citrate	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, COATED, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 19 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
ferrosoferric oxide	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE / ORAL		11 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
palm oil	PALM OIL	5QUO05548Z	SOAP / TOPICAL	NA		Exact identifier — unii candidate
ferric oxide yellow	FERRIC OXIDE YELLOW	EX438O2MRT	GRANULE, FOR SUSPENSION / ORAL		11 mg	Exact identifier — unii candidate 20 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
silica dimethyl silylate	SILICA DIMETHYL SILYLATE	EU2PSP0G0W	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 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
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SUSPENSION / ORAL		2553 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	CAPSULE, EXTENDED RELEASE / ORAL	4.53 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	0.15 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
soybean oil	SOYBEAN OIL	241ATL177A	CAPSULE / ORAL		1318 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ferrosoferric oxide	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
triethyl citrate	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, ORALLY DISINTEGRATING / ORAL		17 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
ferric oxide yellow	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
triethyl citrate	TRIETHYL CITRATE	8Z96QXD6UM	TABLET / ORAL		52 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 49 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
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
triethyl citrate	TRIETHYL CITRATE	8Z96QXD6UM	GRANULE, FOR SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ferrosoferric oxide	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, COATED / ORAL	0.11 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
triethyl citrate	TRIETHYL CITRATE	8Z96QXD6UM	SUSPENSION / ORAL		71 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ferric oxide yellow	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
soybean oil	SOYBEAN OIL	241ATL177A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 7 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	TABLET, FILM COATED / ORAL		3 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	SYSTEM / TRANSDERMAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
high density polyethylene	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	CAPSULE / ORAL	10 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
triethyl citrate	TRIETHYL CITRATE	8Z96QXD6UM	SUSPENSION, EXTENDED RELEASE / ORAL		5 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
triethyl citrate	TRIETHYL CITRATE	8Z96QXD6UM	CAPSULE, EXTENDED RELEASE / ORAL		129 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
silica dimethyl silylate	SILICA DIMETHYL SILYLATE	EU2PSP0G0W	CREAM / VAGINAL		50 mg	Exact identifier — unii candidate 7 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
triethyl citrate	TRIETHYL CITRATE	8Z96QXD6UM	TABLET, EXTENDED RELEASE / ORAL		160 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ferric oxide red	FERRIC OXIDE RED	1K09F3G675	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 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
4957f46b-bde3-4fe4-9d70-d69be51733f8			9ca46ef6-d607-4f0c-b129-63a362cc32c8	2018-12-20	Warnings	Exact identifier spl set id: 9ca46ef6-d607-4f0c-b129-63a362cc32c8

Reported adverse events (FAERS/openFDA)#

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