CLINIQUE SPF 50 face cream

Manufacturer: CLINIQUE LABORATORIES INC. | 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: 2011-10-12
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:29:50

Label at a glance#

ProductSPF 50 with SOLAR SMART

Active ingredientoxybenzone, octisalate, homosalate, avobenzone, octocrylene

Label structure6 sections

Label contents#

Full prescribing information#

TO USE

DOSAGE & ADMINISTRATION SECTION

Apply liberally before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply frequently, and after towel drying, swimming or perspiring.

WARNING

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash or irritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help right away.

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

OXYBENZONE 5.0%, OCTISALATE 5.0%, HOMOSALATE 5.0%, AVOBENZONE 3.0%, OCTOCRYLENE 2.7%.

INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER • METHYL TRIMETHICONE • BUTYLENE GLYCOL • BUTYLOCTYL SALICYLATE • NEOPENTYL GLYCOL DIHEPTANOATE • BUTYROSPERMUM PARKII (SHEA BUTTER) • PEG-100 STEARATE • SILICA • DI-PENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • DIMETHICONE • GLYCERYL STEARATE • LAURDIMONIUM HYDROXYPROPYL HYDROLYZED SOY PROTEIN • ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT • PERILLA OCYMOIDES LEAF EXTRACT • PLANKTON EXTRACT • CAFFEINE • POTASSIUM CETYL PHOSPHATE • SUCROSE • STYRENE/ACRYLATES COPOLYMER • C30-38 OLEFIN/ISOPROPYL MALEATE/MA COPOLYMER • CETYL ALCOHOL • VP/EICOSENE COPOLYMER • ETHYLHEXYLGLYCERIN • AMMONIUM ACRYLOYLDIMETHYL TAURATE/VP COPOLYMER • PEG-8 LAURATE • SODIUM RNA • LECITHIN • PROPYL GALLATE • ARGININE FERULATE • TOCOPHERYL ACETATE • CAPRYLYL GLYCOL • ASCORBYL TOCOPHERYL MALEATE • STEARIC ACID • XANTHAN GUM • HEXYLENE GLYCOL • NORDIHYDROGUAIARETIC ACID • DISODIUM EDTA • PHENOXYETHANOL • MICA • SODIUM DEHYDROACETATE [ILN37123]

SPL UNCLASSIFIED SECTION

CLINIQUE LABS., DIST.
NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLINIQUE
SPF
50
with
SolarSmart

UVA UVB
advanced
protection

face cream

1.7 FL.OZ.
50 ml e

PRINCIPAL DISPLAY PANEL - 50 ml Bottle 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
49527-717-01	2020-01-31	C162847	48780-1	9d75b9d0-05c5-f424-e053-dadaa90a57ce	CLINIQUE SPF 50 face cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49527-717-01	SPF 50 with SOLAR SMART	50 mL in 1 BOTTLE	CREAM	50		1
49527-717-01	SPF 50 with SOLAR SMART	1 in 1 CARTON	CREAM	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49527-717	SPF 50 (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]	1	Legacy NDC, 2 package rows	20111021_e0f986c0-2be3-47ae-aef8-a8a3f14e9cee.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
avobenzone	ACTIVE INGREDIENT	G63QQF2NOX	1
homosalate	ACTIVE INGREDIENT	V06SV4M95S	1
octisalate	ACTIVE INGREDIENT	4X49Y0596W	1
octocrylene	ACTIVE INGREDIENT	5A68WGF6WM	1
oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	1
avobenzone	ACTIVE MOIETY	G63QQF2NOX	1
homosalate	ACTIVE MOIETY	V06SV4M95S	1
octisalate	ACTIVE MOIETY	4X49Y0596W	1
octocrylene	ACTIVE MOIETY	5A68WGF6WM	1
oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	1
alpha-tocopherol acetate	INACTIVE INGREDIENT	9E8X80D2L0	1
butylene glycol	INACTIVE INGREDIENT	3XUS85K0RA	1
butyloctyl salicylate	INACTIVE INGREDIENT	2EH13UN8D3	1
caffeine	INACTIVE INGREDIENT	3G6A5W338E	1
caprylyl glycol	INACTIVE INGREDIENT	00YIU5438U	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	1
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	1
ethylhexylglycerin	INACTIVE INGREDIENT	147D247K3P	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	1
hexylene glycol	INACTIVE INGREDIENT	KEH0A3F75J	1
masoprocol	INACTIVE INGREDIENT	7BO8G1BYQU	1
methyl trimethicone	INACTIVE INGREDIENT	S73ZQI0GXM	1
mica	INACTIVE INGREDIENT	V8A1AW0880	1
neopentyl glycol diheptanoate	INACTIVE INGREDIENT	5LKW3C543X	1
peg-100 stearate	INACTIVE INGREDIENT	YD01N1999R	1
peg-8 laurate	INACTIVE INGREDIENT	762O8IWA10	1
perilla frutescens leaf	INACTIVE INGREDIENT	T4L5881Y68	1
phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	1
potassium cetyl phosphate	INACTIVE INGREDIENT	03KCY6P7UT	1
propyl gallate	INACTIVE INGREDIENT	8D4SNN7V92	1
rosemary	INACTIVE INGREDIENT	IJ67X351P9	1
shea butter	INACTIVE INGREDIENT	K49155WL9Y	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
sodium dehydroacetate	INACTIVE INGREDIENT	8W46YN971G	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	1
sucrose	INACTIVE INGREDIENT	C151H8M554	1
water	INACTIVE INGREDIENT	059QF0KO0R	1
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	1

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

SPF 50 with SOLAR SMART
oxybenzone, octisalate, homosalate, avobenzone, and octocrylene
oxybenzone
octisalate
homosalate
avobenzone
octocrylene
water
methyl trimethicone
butylene glycol
butyloctyl salicylate
neopentyl glycol diheptanoate
shea butter
peg-100 stearate
silicon dioxide
dimethicone
glyceryl monostearate
rosemary
perilla frutescens leaf
caffeine
potassium cetyl phosphate
sucrose
cetyl alcohol
ethylhexylglycerin
peg-8 laurate
propyl gallate
alpha-tocopherol acetate
caprylyl glycol
stearic acid
xanthan gum
hexylene glycol
masoprocol
edetate disodium
phenoxyethanol
mica
sodium dehydroacetate

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49527-717	49527-717-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
oxybenzone	95OOS7VE0Y	ACTIB
octisalate	4X49Y0596W	ACTIB
homosalate	V06SV4M95S	ACTIB
avobenzone	G63QQF2NOX	ACTIB
octocrylene	5A68WGF6WM	ACTIB
water	059QF0KO0R	IACT
methyl trimethicone	S73ZQI0GXM	IACT
butylene glycol	3XUS85K0RA	IACT
butyloctyl salicylate	2EH13UN8D3	IACT
neopentyl glycol diheptanoate	5LKW3C543X	IACT
shea butter	K49155WL9Y	IACT
peg-100 stearate	YD01N1999R	IACT
silicon dioxide	ETJ7Z6XBU4	IACT
dimethicone	92RU3N3Y1O	IACT
glyceryl monostearate	230OU9XXE4	IACT
rosemary	IJ67X351P9	IACT
perilla frutescens leaf	T4L5881Y68	IACT
caffeine	3G6A5W338E	IACT
potassium cetyl phosphate	03KCY6P7UT	IACT
sucrose	C151H8M554	IACT
cetyl alcohol	936JST6JCN	IACT
ethylhexylglycerin	147D247K3P	IACT
peg-8 laurate	762O8IWA10	IACT
propyl gallate	8D4SNN7V92	IACT
alpha-tocopherol acetate	9E8X80D2L0	IACT
caprylyl glycol	00YIU5438U	IACT
stearic acid	4ELV7Z65AP	IACT
xanthan gum	TTV12P4NEE	IACT
hexylene glycol	KEH0A3F75J	IACT
masoprocol	7BO8G1BYQU	IACT
edetate disodium	7FLD91C86K	IACT
phenoxyethanol	HIE492ZZ3T	IACT
mica	V8A1AW0880	IACT
sodium dehydroacetate	8W46YN971G	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 6 · 303 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
edetate disodium	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / RECTAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, EXTENDED RELEASE / TRANSDERMAL	49 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	POWDER, FOR SUSPENSION / ORAL	1203 mg/5ml		Exact identifier — unii candidate 26 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	AEROSOL, FOAM / TOPICAL	0.27 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	CREAM / VAGINAL		1088 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
butylene glycol	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TRANSDERMAL	8.12 mg		Exact identifier — unii candidate 2 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, EXTENDED RELEASE / ORAL		200 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	DROPS / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	ENEMA / RECTAL		150 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	DROPS / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SYSTEM / IONTOPHORESIS	0.1 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
peg-100 stearate	PEG-100 MONOSTEARATE	YD01N1999R	CREAM / VAGINAL		100 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRACARDIAC		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 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
edetate disodium	EDETATE DISODIUM	7FLD91C86K	TABLET / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	CAPSULE / ORAL		90 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, EFFERVESCENT / ORAL		32 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	AEROSOL, FOAM / TOPICAL	8 %w/w		Exact identifier — unii candidate 26 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
xanthan gum	XANTHAN GUM	TTV12P4NEE	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.6 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / SOFT TISSUE	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	SUPPOSITORY / RECTAL	35 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, DELAYED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / OPHTHALMIC	0.06 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	INJECTION / INTRAVENOUS		1950 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
hexylene glycol	HEXYLENE GLYCOL	KEH0A3F75J	SOLUTION / TOPICAL	0.3 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED / ORAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	GRANULE / ORAL	NA		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
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
shea butter	SHEA BUTTER	K49155WL9Y	LOTION / TOPICAL		2340 mg	Exact identifier — unii candidate

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
ed67f891-45eb-4ce2-a39e-91d71ec741a8			e0f986c0-2be3-47ae-aef8-a8a3f14e9cee	2011-10-12	Warnings	Exact identifier spl id: ed67f891-45eb-4ce2-a39e-91d71ec741a8 spl set id: e0f986c0-2be3-47ae-aef8-a8a3f14e9cee

Reported adverse events (FAERS/openFDA)#

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