FDA.reportPublic FDA data

Green Tea Antioxidant Broad Spectrum SPF 30 PAplusplusplus

Manufacturer
H2O Plus LLC
Effective date
2015-02-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:41:59

Label at a glance#

ProductGreen Tea Antioxidant Broad Spectrum SPF 30 PAplusplusplus
Active ingredientOxybenzone, Octisalate, Avobenzone
Label structure9 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

Dosage and administration

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

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 IngredientsPurpose
Oxybenzone 6.0%Sunscreen
Octisalate 5.0%Sunscreen
Avobenzone 3.0%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

Warnings

WARNINGS SECTION

  • For external use only

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs

When using this product

OTC - WHEN USING SECTION

  • Keep out of eyes, Rinse with water to remove.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • For Sunscreen use
  • Apply liberally 15 minutes before sun exposure
  • Use water resistance sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months: Ask a doctor

Sun Protection Measures

SPL UNCLASSIFIED SECTION

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 am-2 pm
  • Wear long-sleeved shirts, pants, and sunglasses

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau, Ethylhexyl Isononanoate, Butylene Glycol, Glyceryl Stearate, C12-15 Alkyl Benzoate, Pentylene Glycol, Triisononanoin, Diethylhexyl 2,6-Naphthalate, Cera Alba/ Beeswax/Cire d'abeille, Sodium Dihydroxycetyl Phosphate, Polyglyceryl-3 Caprate, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Camellia Sinensis Leaf Extract, Faex/Yeast Extract/Extrait de levure, Fucus Vesiculosus Extract, Ilex Paraguariensis Leaf Extract, Panax Ginseng Root Extract, Tilia Cordata Wood Extract, Magnesium Ascorbyl Phosphate, Tocopherol, Biotin, Calcium Pantothenate, Carbomer, Citric Acid, Disodium EDTA, Glycerin, Glycogen, Hydrogenated Palm Glycerides, Hydrolyzed Wheat Protein, Lecithin, Mannitol, Maris Sal/Sea Salt/Sel Marin, Propylene Glycol, Thermus Thermophillus Ferment, Triethanolamine, Xanthan Gum, Chlorphenesin, Methylparaben, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate (090-00330-002)

Other information

STORAGE AND HANDLING SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by:
H2O Plus, L.L.C. Chicago, IL 60607

PRINCIPAL DISPLAY PANEL - 38 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

h2o+®

marine DEFENSE

Anti-aging environmental
protection

GREEN TEA
ANTIOXIDANT LOTION
BROAD SPECTRUM
SPF 30 PA+++

Nourishes and protects
against free-radical
damage

38 mL / 1.3 U.S. Fl oz e

Principal Display Panel - 38 mL Bottle Carton
Principal Display Panel - 38 mL Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65903-330-012020-01-31C16284748780-19d75b9cf-f08c-f424-e053-dadaa90a57ceGreen Tea Antioxidant Broad Spectrum SPF 30 PA+++

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65903-330-01Green Tea Antioxidant Broad Spectrum SPF 30 PAplusplusplus38 mL in 1 BOTTLE, PUMPLOTION381
65903-330-01Green Tea Antioxidant Broad Spectrum SPF 30 PAplusplusplus1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65903-330GREEN TEA ANTIOXIDANT BROAD SPECTRUM SPF 30 PAPLUSPLUSPLUS (OXYBENZONE, OCTISALATE, AND AVOBENZONE) LOTION [H2O PLUS LLC]1Legacy NDC, 2 package rows20150317_920c26fe-dbae-478f-948e-d68bc90a4ef5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX1
OctisalateACTIVE INGREDIENT4X49Y0596W1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
AvobenzoneACTIVE MOIETYG63QQF2NOX1
OctisalateACTIVE MOIETY4X49Y0596W1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
Alkyl (C12-15) BenzoateINACTIVE INGREDIENTA9EJ3J61HQ1
Asian GinsengINACTIVE INGREDIENTCUQ3A77YXI1
BiotinINACTIVE INGREDIENT6SO6U10H041
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA1
Calcium PantothenateINACTIVE INGREDIENT568ET80C3D1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27E1
ChlorphenesinINACTIVE INGREDIENTI670DAL4SZ1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QP1
DIETHYLHEXYL 2,6-NAPHTHALATEINACTIVE INGREDIENTI0DQJ7YGXM1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K1
ETHYLHEXYL ISONONANOATEINACTIVE INGREDIENTI6KB4GE3K41
Fucus VesiculosusINACTIVE INGREDIENT535G2ABX9M1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE41
GlycogenINACTIVE INGREDIENT309GSC92U11
Green Tea LeafINACTIVE INGREDIENTW2ZU1RY8B01
Horse ChestnutINACTIVE INGREDIENT3C18L6RJAZ1
Hydrogenated Palm GlyceridesINACTIVE INGREDIENTYCZ8EM144Q1
Ilex Paraguariensis LeafINACTIVE INGREDIENT1Q953B4O4F1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM621
Magnesium Ascorbyl PhosphateINACTIVE INGREDIENT0R822556M51
MannitolINACTIVE INGREDIENT3OWL53L36A1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T1
Pentylene GlycolINACTIVE INGREDIENT50C1307PZG1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
Potassium SorbateINACTIVE INGREDIENT1VPU26JZZ41
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
Sea SaltINACTIVE INGREDIENT87GE52P74G1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EU1
Sodium Dihydroxycetyl PhosphateINACTIVE INGREDIENTYWI33EV5951
THERMUS THERMOPHILUS LYSATEINACTIVE INGREDIENT775R6924941
Tilia Cordata WoodINACTIVE INGREDIENT674MYE89IE1
TocopherolINACTIVE INGREDIENTR0ZB2556P81
TriisononanoinINACTIVE INGREDIENTXF4K22WN6T1
TrolamineINACTIVE INGREDIENT9O3K93S3TK1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEE1
YeastINACTIVE INGREDIENT3NY3SM6B8U1
Yellow WaxINACTIVE INGREDIENT2ZA36H0S2V1

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65903-33065903-330-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
Oxybenzone95OOS7VE0YACTIB
Octisalate4X49Y0596WACTIB
AvobenzoneG63QQF2NOXACTIB
ETHYLHEXYL ISONONANOATEI6KB4GE3K4IACT
Butylene Glycol3XUS85K0RAIACT
Glyceryl Monostearate230OU9XXE4IACT
Alkyl (C12-15) BenzoateA9EJ3J61HQIACT
Pentylene Glycol50C1307PZGIACT
TriisononanoinXF4K22WN6TIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
Yellow Wax2ZA36H0S2VIACT
Sodium Dihydroxycetyl PhosphateYWI33EV595IACT
Tilia Cordata Wood674MYE89IEIACT
Horse Chestnut3C18L6RJAZIACT
Green Tea LeafW2ZU1RY8B0IACT
Yeast3NY3SM6B8UIACT
Fucus Vesiculosus535G2ABX9MIACT
Ilex Paraguariensis Leaf1Q953B4O4FIACT
Asian GinsengCUQ3A77YXIIACT
Magnesium Ascorbyl Phosphate0R822556M5IACT
TocopherolR0ZB2556P8IACT
Biotin6SO6U10H04IACT
Calcium Pantothenate568ET80C3DIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
Citric Acid Monohydrate2968PHW8QPIACT
Edetate Disodium7FLD91C86KIACT
GlycerinPDC6A3C0OXIACT
Glycogen309GSC92U1IACT
Hydrogenated Palm GlyceridesYCZ8EM144QIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
Mannitol3OWL53L36AIACT
Sea Salt87GE52P74GIACT
Propylene Glycol6DC9Q167V3IACT
THERMUS THERMOPHILUS LYSATE775R692494IACT
Trolamine9O3K93S3TKIACT
Xanthan GumTTV12P4NEEIACT
ChlorphenesinI670DAL4SZIACT
MethylparabenA2I8C7HI9TIACT
PhenoxyethanolHIE492ZZ3TIACT
Potassium Sorbate1VPU26JZZ4IACT

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 11 · 629 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
MannitolMANNITOL3OWL53L36APOWDER / RESPIRATORY (INHALATION)6 mgExact identifier — unii candidate
65 equally ranked IID candidates
LECITHIN, SOYBEANSOYBEAN LECITHIN1DI56QDM62TABLET, EXTENDED RELEASE / ORAL20 mgExact identifier — unii candidate
7 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR38 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ATABLET, CHEWABLE / ORAL3726 mgExact identifier — unii candidate
65 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KEMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4LOTION / TOPICAL177 mgExact identifier — unii candidate
21 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSYSTEM / TOPICAL126 mgExact identifier — unii candidate
77 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESUSPENSION / ORAL360 mgExact identifier — unii candidate
29 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETABLET / ORAL56 mgExact identifier — unii candidate
29 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TDROPS / AURICULAR (OTIC)0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SOFT TISSUE0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii candidate
9 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAVENOUS7 mgExact identifier — unii candidate
77 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
81 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KGEL / VAGINAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii candidate
35 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, EXTENDED RELEASE / ORAL32.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ATABLET, ORALLY DISINTEGRATING / SUBLINGUAL10.25 mgExact identifier — unii candidate
65 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / INTRAVENOUS0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRACARDIAC2 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii candidate
81 equally ranked IID candidates
MannitolMANNITOL3OWL53L36AINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS35 mgExact identifier — unii candidate
65 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / TOPICAL3.27 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / SOFT TISSUE1 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KLIQUID / NASAL2 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ATABLET / BUCCAL360 mgExact identifier — unii candidate
65 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KCREAM / VAGINAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSOLUTION / NASAL100 mg/100mlExact identifier — unii candidate
77 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii candidate
79 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / IONTOPHORESIS0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
Yellow WaxYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TOINTMENT / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KGEL / OPHTHALMIC396 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / SOFT TISSUE0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
29 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUINJECTION / INTRAVENOUS864 mgExact identifier — unii candidate
35 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSPRAY, METERED / NASAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EOINTMENT, AUGMENTED / TOPICAL23 mgExact identifier — unii candidate
9 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii candidate
77 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
MannitolMANNITOL3OWL53L36ASUSPENSION/ DROPS / OPHTHALMIC3.3 %w/vExact identifier — unii candidate
65 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE, EXTENDED RELEASE / ORAL101 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPFILM / SUBLINGUAL10 mgExact identifier — unii candidate
88 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSOLUTION / INTRAVENOUS0.05 %w/vExact identifier — unii candidate
77 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
8d25de87-7bb0-4114-b07e-787f95a29969920c26fe-dbae-478f-948e-d68bc90a4ef52015-02-26WarningsExact identifier
spl id: 8d25de87-7bb0-4114-b07e-787f95a29969
spl set id: 920c26fe-dbae-478f-948e-d68bc90a4ef5

Reported adverse events (FAERS/openFDA)#

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