FDA.reportPublic FDA data

NDC 67938-2082-2 - PRO TRIPLE PROTECTION FACTOR LIP BALM 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
67938-2082
Requested NDC
67938-2082-2
Package NDCs from labels
67938-2082-2, 67938-2082-1
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, OCTISALATE, AVOBENZONE, ZINC OXIDE - ELIZABETH ARDEN, INCELIZABETH ARDEN, INC2017-02-01HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67938-2082-12020-09-27C16284748780-1ab0e2407-2e08-f274-e053-dbdaa90a647150ad0b74-826f-4222-b347-98413d9484bd
67938-2082-12020-09-25C16284748780-1ab0e2407-2e08-f274-e053-dbdaa90a647150ad0b74-826f-4222-b347-98413d9484bd
67938-2082-12020-07-22C16284748780-1ab0e2407-2e08-f274-e053-dbdaa90a647150ad0b74-826f-4222-b347-98413d9484bd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67938-2082-1PRO TRIPLE PROTECTION FACTOR LIP BALM BROAD SPECTRUM SPF 30 SUNSCREEN1 in 1 BOXLOTION11
67938-2082-2PRO TRIPLE PROTECTION FACTOR LIP BALM BROAD SPECTRUM SPF 30 SUNSCREEN14.2 g in 1 BOTTLELOTION14.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67938-2082PRO TRIPLE PROTECTION FACTOR LIP BALM BROAD SPECTRUM SPF 30 SUNSCREEN (OCTINOXATE, OCTISALATE, AVOBENZONE, ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC]1Legacy NDC, 2 package rows20170209_50ad0b74-826f-4222-b347-98413d9484bd.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 6 of 406 · 8,116 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAWAIIAN TROPICAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC5990fe66-4fa2-06aa-e063-6294a90a52612026-08-21WarningsExact identifier
unii: G63QQF2NOX
Hawaiian TropicAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC5991466a-e729-16b7-e063-6394a90a11ff2026-08-21WarningsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela163f388e-849d-4b7e-93c1-9045d77a9ec22026-08-21WarningsExact identifier
unii: SOI2LOH54Z
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP0073de92-585d-e01a-e063-6394a90a2ec22026-08-21WarningsExact identifier
unii: SOI2LOH54Z
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC597b78df-83cb-1b21-e063-6294a90a56a82026-08-20Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
Sunski Base Camp Face and Body Sunscreen SPF 45HOMOSALATE, OCTISALATE, AVOBENZONEStewart Charley Ventures, LLC2fc45f85-a6f8-4893-8b34-4db5e39cb6152026-08-20WarningsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: SOI2LOH54Z
SunscreenBROAD SPECTRUM SPF 30Concierge Choice LLC5980055b-493e-4763-e063-6294a90a570f2026-08-20WarningsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
ClaraVieZINC OXIDEGentell LLC596abd98-17d7-2a22-e063-6294a90af57d2026-08-19WarningsExact identifier
unii: SOI2LOH54Z
ClaravieLANOLINGentell LLC596c1b73-e34d-c97d-e063-6394a90ada1b2026-08-19WarningsExact identifier
unii: 7EV65EAW6H
Lip Balm SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENESkin Script, LLC20c5fde7-ee8f-4b74-e063-6394a90a93ec2026-08-19WarningsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
unii: 4Y5P7MUD51
ClaraVieMENTHOL, ZINC OXIDEGentell LLC596c467f-a056-ea78-e063-6394a90a79f22026-08-19WarningsExact identifier
unii: SOI2LOH54Z
Aloe UP .5OZ SPF 50 MINERAL SunscreenZINC OXIDE 14.69%Aloe Care International, LLC6ad80af3-78cd-4211-a5f2-68531aae264a2026-08-19WarningsExact identifier
unii: SOI2LOH54Z
Utu Broad Spectrum SPF 50 Tinted Sunscreen-StickZINC OXIDEUtu Co596e17d3-3064-1cda-e063-6294a90af9632026-08-19WarningsExact identifier
unii: SOI2LOH54Z
ClaraVieLANOLINGentell LLC596fe32d-be34-0635-e063-6394a90a2fc02026-08-19WarningsExact identifier
unii: 7EV65EAW6H
Mineral sunscreenMINERAL SUNSCREENGuangzhou Origin Beauty Cosmetics Co., Ltd.59713657-a7ef-1aee-e063-6394a90a326e2026-08-19WarningsExact identifier
unii: SOI2LOH54Z
The Naked Bee SPF 50 Mineral SunscreenZINC OXIDE 14.69%The Naked Beef820a9be-c94d-4fd5-b202-2dda5746a82a2026-08-18WarningsExact identifier
unii: SOI2LOH54Z
The Naked Bee SPF 50 Mineral SunscreenZINC OXIDE 20%The Naked Bee7dd2b1cd-e229-4eeb-8122-46fde5af10912026-08-18WarningsExact identifier
unii: SOI2LOH54Z
MedprideZINC OXIDEShield Line LLCe2689cae-e347-4c0b-825b-6281a0b7c2f12026-08-18WarningsExact identifier
unii: SOI2LOH54Z
Sun Zapper - Baby pure zinc sunscreen SPF30ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED3ee52faa-64a8-4bdf-e063-6294a90a65cf2026-08-17WarningsExact identifier
unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

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