FDA.reportPublic FDA data

NDC 67938-2076-2 - PRO TRIPLE PROTECTION FACTOR FACE AND BODY BROAD SPECTRUM SPF 30 SUNSCREEN

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
67938-2076
Requested NDC
67938-2076-2
Package NDCs from labels
67938-2076-2, 67938-2076-1
Manufacturer
ELIZABETH ARDEN, INC
Effective date
2017-02-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OCTINOXATE - ELIZABETH ARDEN, INCELIZABETH ARDEN, INC2017-02-01HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67938-2076-12020-09-27C16284748780-1ab0e2407-2bde-f274-e053-dbdaa90a6471Drug Facts
67938-2076-12020-09-25C16284748780-1ab0e2407-2bde-f274-e053-dbdaa90a6471Drug Facts
67938-2076-12020-07-22C16284748780-1ab0e2407-2bde-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67938-2076-1PRO TRIPLE PROTECTION FACTOR FACE AND BODY BROAD SPECTRUM SPF 30 SUNSCREEN1 in 1 BOXLOTION11
67938-2076-2PRO TRIPLE PROTECTION FACTOR FACE AND BODY BROAD SPECTRUM SPF 30 SUNSCREEN120 mL in 1 BOTTLELOTION1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67938-2076PRO TRIPLE PROTECTION FACTOR FACE AND BODY BROAD SPECTRUM SPF 30 SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE, OCTOCRYLENE, AVOBENZONE) LOTION [ELIZABETH ARDEN, INC]1Legacy NDC, 2 package rows20170302_e4ec1f6d-8440-43f7-9263-ee969901d09d.zip

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 8 of 238 · 4,752 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AVOBENZONE, HOMOSALATE, OCTISALATEAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC58636012-7e29-7206-e063-6394a90a83e92026-08-06Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
AVOBENZONE, HOMOSALATE, OCTISALATEAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC5864275d-a480-06f8-e063-6394a90aecab2026-08-06Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5864881c-c495-1f32-e063-6294a90a13042026-08-06Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC58653d79-8fff-f319-e063-6294a90af7a32026-08-06Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATETopco Associates LLC5865f0e5-14b2-c4bf-e063-6294a90a47102026-08-06Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
NHLMA Skin Defense SunscreenBROAD SPECTRUM SPF 30NATIONAL HAIR LOSS LLC56326ae0-387f-ad08-e063-6294a90acc4f2026-08-06WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
ROROBELL WAWA Kids Tooth Natural Green Grape FlavorHYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEROROBELL586b499d-23bf-0116-e063-6394a90aa7d42026-08-06WarningsExact identifier
unii: 9E8X80D2L0
AMAZON EXTRA STRENGTHSIMETHICONEAMAZON.COM SERVICES LLC705489ce-ac7c-44a8-8298-ead19824582e2026-08-06WarningsExact identifier
unii: 92RU3N3Y1O
Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30AVOBENZONE, HOMOSALATE, OCTOCRYLENEKenvue Brands LLC129ae274-0094-be5e-e063-6394a90a98012026-08-05WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Leader Kids Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH 110, LLC. DBA LEADER3636693a-ba81-5d49-e063-6394a90a30062026-08-05WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Gencare-Gas ReliefSIMETHICONE 180 MGPIONEER LIFE SCIENCES, LLCb7f2d5db-c1b7-4c01-8ee6-017e4b9f14252026-08-04WarningsExact identifier
unii: 92RU3N3Y1O
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: 9E8X80D2L0
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 5A68WGF6WM
unii: 4X49Y0596W
ROROBELL WAWA Gum Care ToothHYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEROROBELL582204ef-b784-0d95-e063-6394a90a38d22026-08-03WarningsExact identifier
unii: 9E8X80D2L0
Manyo Air Light Moisturizing Sunscreen SPF 50ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENEManyo Factory Corp.86761577-a32c-41a2-a2e3-b339b14937012026-08-03WarningsExact identifier
unii: 5A68WGF6WM
unii: 4X49Y0596W
SimethiconeSIMETHICONEAphena Pharma Solutions - Tennessee, LLCda0cc98e-1692-405a-ab81-420d6f9df6de2026-07-31WarningsExact identifier
unii: 92RU3N3Y1O
AMBI SKINCARE Even and Clear Daily Facial Moisturizer SPF 30OCTISALATE, OCTOCRYLENE, AVOBENZONEAMBI Enterprises LLC99bbe9a2-bb57-4a33-b339-1649d4b319c82026-07-31WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
AMBI Even and Clear Facial Moisturizer SPF-30AVOBENZONE, OCTISALATE, OCTOCRYLENEAMBI Enterprises LLC4701c0ba-4ceb-4d66-9f99-515ce33b46482026-07-31WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Continuous Correction CreamHOMOSALATE 10% OCTISALATE 4.9% OCTOCRYLENE 4%Baxter of California, LLC14b05c8c-0398-2973-e063-6394a90a8a862026-07-31WarningsExact identifier
unii: 5A68WGF6WM
unii: 4X49Y0596W

Reported adverse events (FAERS/openFDA)#

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