UltraSensitive Tint

Manufacturer
Dermalogica, Inc. | PakLab | Diamond Wipes
Effective date
2015-11-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:44:08

Label at a glance#

ProductUltraSensitive Tint SPF 30
Active ingredientTitanium Dioxide
Label structure10 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), may decrease the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

apply liberally 15 minutes before sun exposure reapply: at least 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 help decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especiall...

Storage and handling

Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 11.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), may decrease the risk of skin cancer and early skin aging caused by the sun.

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

OTC - DO NOT USE SECTION

Do not use if seal is broken.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • at least 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 help decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats and sunglasses
  • Children under 6 months: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua, Butylene Glycol, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Neopentyl Glycol Diethylhexanoate, Arachidyl Alcohol, PEG-10 Dimethicone, Dimethicone, Behenyl Alcohol, Leuconostoc/Radish Root Ferment Filtrate, Stearyl Dimethicone, Potassium Cetyl Phosphate, Camellia Oleifera Leaf Extract, Avena Sativa (Oat) Kernel Extract, Boerhavia Diffusa Root Extract, Melissa Officinalis Extract, Vitis Vinifera (Grape) Seed Extract, Citrus Medica Limonum (Lemon) Peel Extract, Centella Asiatica Extract, Echinacea Purpurea Extract, Zingiber Officinale (Ginger) Root Extract, Citrus Grandis (Grapefruit) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Thymus Vulgaris (Thyme) Oil, Pelargonium Graveolens Oil, Aniba Rosaeodora (Rosewood) Wood Oil, Citrus Aurantium Dulcis (Orange) Oil, Bisabolol, Tocopherol, Lecithin, Panthenol, Sodium Lactate, Sodium PCA, Sorbitol, Proline, Pentylene Glycol, Hydroxyphenyl Propamidobenzoic Acid, Glycerin, Magnesium Ascorbyl Phosphate, Silica, Arachidyl Glucoside, Cetearyl Alcohol, Ceteareth-20, Sodium DNA, Ascorbyl Tetraisopalmitate, Neopentyl Glycol Diisostearate, Alumina, Methicone, Stearic Acid, Aluminum Hydroxide, Polyglyceryl-2 Dipolyhydroxy Stearate, Polyglyceryl-3 Diiostearate, Xanthan Gum, Magnesium Aluminum Silicate, Carbomer, Disodium EDTA, Sodium Benzoate, Potassium Sorbate, Sodium Hydroxide, Iron Oxides (77491, 77492, 77499).

Other information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun

Questions or comments

OTC - QUESTIONS SECTION

Call toll free
1-800-831-5150 in the US

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dermalogica®

ultra
sensitive
tint

spf
30

broad
spectrum

NPN# 80031341

UltraCalming™

1.7 US Fl. Oz.
50 mL e

Principal Display Panel - 50 mL Tube Carton
Principal Display Panel - 50 mL Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68479-120-002020-01-31C16284748780-19d75b9d0-ac33-f424-e053-dadaa90a57ceUltraSensitive Tint SPF 30
68479-120-022020-01-31C16284748780-19d75b9d0-ac33-f424-e053-dadaa90a57ceUltraSensitive Tint SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68479-120-00UltraSensitive Tint SPF 302 mL in 1 POUCHLOTION22
68479-120-02UltraSensitive Tint SPF 3050 mL in 1 TUBELOTION502
68479-120-02UltraSensitive Tint SPF 301 in 1 CARTONLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68479-120ULTRASENSITIVE TINT SPF 30 (TITANIUM DIOXIDE) LOTION [DERMALOGICA, INC.]2Legacy NDC, 3 package rows20151119_2defa4fa-ca65-4cd1-9ec8-0039360429f7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP2
Titanium DioxideACTIVE MOIETY15FIX9V2JP2
Alkyl (C12-15) BenzoateINACTIVE INGREDIENTA9EJ3J61HQ2
Aluminum HydroxideINACTIVE INGREDIENT5QB0T2IUN02
Aluminum OxideINACTIVE INGREDIENTLMI26O69332
Arachidyl AlcoholINACTIVE INGREDIENT1QR1QRA9BU2
Arachidyl GlucosideINACTIVE INGREDIENT6JVW35JOOJ2
Ascorbyl TetraisopalmitateINACTIVE INGREDIENT47143LT58A2
Boerhavia Diffusa RootINACTIVE INGREDIENTKR0SR09KYL2
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA2
Camellia Oleifera LeafINACTIVE INGREDIENT5077EL0C602
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked)INACTIVE INGREDIENT4Q93RCW27E2
Centella AsiaticaINACTIVE INGREDIENT7M867G6T1U2
Cetostearyl AlcoholINACTIVE INGREDIENT2DMT128M1S2
Citrus Maxima Fruit Rind OilINACTIVE INGREDIENT8U3877WD442
Cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0R2
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O2
DocosanolINACTIVE INGREDIENT9G1OE216XY2
Echinacea PurpureaINACTIVE INGREDIENTQI7G114Y982
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K2
Egg PhospholipidsINACTIVE INGREDIENT1Z74184RGV2
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G6752
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRT2
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F3572
Geranium Oil, Algerian TypeINACTIVE INGREDIENT5Q1I94P4WG2
GingerINACTIVE INGREDIENTC5529G5JPQ2
GlycerinINACTIVE INGREDIENTPDC6A3C0OX2
Hydroxyphenyl Propamidobenzoic AcidINACTIVE INGREDIENT25KRT26H772
Lavender OilINACTIVE INGREDIENTZBP1YXW0H82
Lemon PeelINACTIVE INGREDIENT72O054U6282
Leuconostoc/Radish Root Ferment FiltrateINACTIVE INGREDIENTD2QHA034582
LevomenolINACTIVE INGREDIENT24WE03BX2T2
Magnesium Aluminum SilicateINACTIVE INGREDIENT6M3P64V0NC2
Magnesium Ascorbyl PhosphateINACTIVE INGREDIENT0R822556M52
Medium-Chain TriglyceridesINACTIVE INGREDIENTC9H2L21V7U2
Melissa OfficinalisINACTIVE INGREDIENTYF70189L0N2
Methicone (20 CST)INACTIVE INGREDIENT6777U11MKT2
Neopentyl Glycol DiethylhexanoateINACTIVE INGREDIENTU68ZV6W62C2
Neopentyl Glycol DiisostearateINACTIVE INGREDIENT4M6OQ34JWW2
OatINACTIVE INGREDIENTZ6J799EAJK2
Orange OilINACTIVE INGREDIENTAKN3KSD11B2
PanthenolINACTIVE INGREDIENTWV9CM0O67Z2
PEG-10 Dimethicone (600 CST)INACTIVE INGREDIENT8PR7V1SVM02
Pentylene GlycolINACTIVE INGREDIENT50C1307PZG2
Polyglyceryl-2 DipolyhydroxystearateINACTIVE INGREDIENT9229XJ4V122
Polyglyceryl-3 DiisostearateINACTIVE INGREDIENT46P231IQV82
Polyoxyl 20 Cetostearyl EtherINACTIVE INGREDIENTYRC528SWUY2
Potassium Cetyl PhosphateINACTIVE INGREDIENT03KCY6P7UT2
Potassium SorbateINACTIVE INGREDIENT1VPU26JZZ42
ProlineINACTIVE INGREDIENT9DLQ4CIU6V2
Rosewood OilINACTIVE INGREDIENTF2522O5L7B2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU42
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EU2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I2
Sodium LactateINACTIVE INGREDIENTTU7HW0W0QT2
Sodium Pyrrolidone CarboxylateINACTIVE INGREDIENT469OTG57A22
SorbitolINACTIVE INGREDIENT506T60A25R2
Stearic AcidINACTIVE INGREDIENT4ELV7Z65AP2
Stearyl Dimethicone (400 MPA.S at 50C)INACTIVE INGREDIENTR327X197HY2
Thyme OilINACTIVE INGREDIENT2UK410MY6B2
TocopherolINACTIVE INGREDIENTR0ZB2556P82
Vitis Vinifera SeedINACTIVE INGREDIENTC34U15ICXA2
WaterINACTIVE INGREDIENT059QF0KO0R2
Xanthan GumINACTIVE INGREDIENTTTV12P4NEE2

Products#

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

DailyMed product names page 1 of 2 · 64 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68479-12068479-120-02, 68479-120-00

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 63 matching rows.

Source Document#

Source XML · Source PDF

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 12 · 682 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET / SUBLINGUAL9 mgExact identifier — unii candidate
26 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APIMPLANT / SUBCUTANEOUS1.04 mgExact identifier — unii candidate
26 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii candidate
44 equally ranked IID candidates
Magnesium Aluminum SilicateMAGNESIUM ALUMINUM SILICATE6M3P64V0NCOINTMENT / VAGINAL231 mgExact identifier — unii candidate
17 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, EXTENDED RELEASE / ORAL450 mgExact identifier — unii candidate
49 equally ranked IID candidates
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked)CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EEMULSION / TOPICAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IFILM, SOLUBLE / ORAL11 mgExact identifier — unii candidate
174 equally ranked IID candidates
SorbitolSORBITOL506T60A25RLOTION / TOPICAL10.7 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
26 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
Ferrosoferric OxideFERROSOFERRIC OXIDEXM0M87F357CAPSULE, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
10 equally ranked IID candidates
Magnesium Aluminum SilicateMAGNESIUM ALUMINUM SILICATE6M3P64V0NCTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
17 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / EPIDURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ITABLET / ORAL10 mgExact identifier — unii candidate
174 equally ranked IID candidates
Ferrosoferric OxideFERROSOFERRIC OXIDEXM0M87F357CAPSULE, EXTENDED RELEASE / ORAL1.49 mgExact identifier — unii candidate
10 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISWAB / TOPICAL0.01 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / IONTOPHORESISADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET, COATED / ORAL12.96 mgExact identifier — unii candidate
44 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.4 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRATHECAL176 mgExact identifier — unii candidate
174 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TAMPON / VAGINALNAExact identifier — unii candidate
49 equally ranked IID candidates
Cetostearyl AlcoholCETOSTEARYL ALCOHOL2DMT128M1STABLET, EXTENDED RELEASE / ORAL800 mgExact identifier — unii candidate
9 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Ferric Oxide YellowFERRIC OXIDE YELLOWEX438O2MRTTABLET, FILM COATED / ORAL6 mgExact identifier — unii candidate
20 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSOLUTION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Ferric Oxide YellowFERRIC OXIDE YELLOWEX438O2MRTPOWDER / RESPIRATORY (INHALATION)0.04 mgExact identifier — unii candidate
20 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-ARTERIAL176 mgExact identifier — unii candidate
174 equally ranked IID candidates
Magnesium Aluminum SilicateMAGNESIUM ALUMINUM SILICATE6M3P64V0NCGRANULE, FOR SUSPENSION / ORAL12.5 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSYSTEM / TOPICAL126 mgExact identifier — unii candidate
77 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET / ORAL337.28 mgExact identifier — unii candidate
44 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Potassium SorbatePOTASSIUM SORBATE1VPU26JZZ4SYRUP / ORAL2 mg/1mlExact identifier — unii candidate
19 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRALESIONALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KCREAM / VAGINAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / ORAL2 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
Sodium LactateSODIUM LACTATETU7HW0W0QTINJECTION / INTRAVENOUS54 mgExact identifier — unii candidate
7 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
18 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAMUSCULAR4 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSPRAY / NASAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Cetostearyl AlcoholCETOSTEARYL ALCOHOL2DMT128M1SCREAM / VAGINAL6 mgExact identifier — unii candidate
9 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IPOWDER, FOR SUSPENSION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii candidate
26 equally ranked IID candidates
Potassium SorbatePOTASSIUM SORBATE1VPU26JZZ4EMULSION / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED, EXTENDED RELEASE / ORAL3.6 mgExact identifier — unii candidate
21 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET / SUBLINGUAL50.5 mgExact identifier — unii candidate
44 equally ranked IID candidates
Potassium SorbatePOTASSIUM SORBATE1VPU26JZZ4TABLET, COATED / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii candidate
35 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / INFILTRATION6 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRATUMORADJ PHExact identifier — unii candidate
174 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
03728265-8b8d-43da-87fc-9e48c7fc0f3b2defa4fa-ca65-4cd1-9ec8-0039360429f72015-11-18WarningsExact identifier
spl id: 03728265-8b8d-43da-87fc-9e48c7fc0f3b
spl set id: 2defa4fa-ca65-4cd1-9ec8-0039360429f7

Reported adverse events (FAERS/openFDA)#

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