Impact Melanoma SPF 30

Product NDC
76348-598
Requested package NDC
76348-598-01
11-digit product format
763480598
Labeler code
76348
Product ID
76348-598_303ba855-5a04-602e-e063-6394a90adcb0
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
RENU LABORATORIES, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-17
Substance
ZINC OXIDE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
Active strength
17.5; 70; 10; 12.5 g/1000g; g/1000g; g/1000g; g/1000g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Impact Melanoma SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE17.5 g/1000g
OCTINOXATE70 g/1000g
OCTISALATE10 g/1000g
TITANIUM DIOXIDE12.5 g/1000g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f953302e-f712-129a-e053-6294a90ab9a8Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-598-012025-03-13C16284748780-12cef2736-85b3-d83d-e063-dadaa90ab31fImpact Melanoma SPF 30
76348-598-012025-01-30C16284748780-12cef2736-85b3-d83d-e063-dadaa90ab31fImpact Melanoma SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-598-01Impact Melanoma SPF 301000 g in 1 JUGLOTION10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-598IMPACT MELANOMA SPF 30 (ZINC OXIDE) LOTION [RENU LABORATORIES, LLC]2Current NDC, 1 package rows20250316_f953302e-f712-129a-e053-6294a90ab9a8.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 210 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rodan and Fields Reverse Brightening Defense Broad Spectrum SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERodan & Fields Beauty, LLCafa2d42e-b54d-4843-b313-0c44fe5c5d522025-06-06WarningsExact identifier
application number: M020
1000 Roses CC Color Plus Correct Sheer Tan SPF 30ZINC OXIDEAndalou naturals9314e4fc-ba3e-480e-a005-b8928130ed702025-06-06WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc Face Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC3169bf3b-a5a8-4c3e-a182-9f24f8ade3ac2025-06-05WarningsExact identifier
application number: M020
Body Glove Sunscreen SPF 30ZINC OXIDE, TITANIUM DIOXIDESCUBASCREEN LLC1d7a960c-4387-44dc-8d4e-881e21a8ae2e2025-06-05WarningsExact identifier
application number: M020
Vacation Classic Mini Whip SPF 30 Broad Spectrum SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEVacation Inc.36d65cb2-c2e7-06d7-e063-6394a90a38222025-06-05WarningsExact identifier
application number: M020
Vacation Classic Whip SPF 50 Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEVacation Inc.36d747fb-b973-5611-e063-6394a90ac6612025-06-05WarningsExact identifier
application number: M020
Non Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d7c8b3-554f-78d9-e063-6394a90a80f32025-06-05Exact identifier
application number: M020
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d80422-943f-3aba-e063-6294a90afb592025-06-05Exact identifier
application number: M020
Mineral Creme SPF 50 Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesf8e178d6-058c-462a-8e59-6721f28ad0402025-06-05WarningsExact identifier
application number: M020
Mineral Tinted SPF 30 Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesadcd6881-fa25-4312-95e5-5b47102aa6b92025-06-05WarningsExact identifier
application number: M020
Mineral Moisture Defense SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences05ad73f3-a4e8-4f78-8212-3e8e3bda988c2025-06-05WarningsExact identifier
application number: M020
Solar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences6ce602bb-c1f4-43c1-ae61-0f05d7952db32025-06-05WarningsExact identifier
application number: M020
Solar stick Tinted SPF 40 Tinted Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesb8f08778-7e5e-4341-9a24-1ce57c6525c72025-06-05WarningsExact identifier
application number: M020
Quick Dry Body Broad Spectrum SPF40 Sunscreen UVA-UVB Sunscreen with SolSci-XAVOBENZONE, OCTISALATE, AND OCTOCRYLENEMDSolarSciences812caa99-1e1e-4ab8-9f9a-fb3384c684dd2025-06-05WarningsExact identifier
application number: M020
MD Daily Perfecting Moisturizer SPF 30. SPF 30 Broad Spectrum Sunscreen UVA-UVBAVOBENZONE, OCTOCRYLENE, AND OCTISALATEMDSolarSciencesba918886-d277-487a-be3b-bbe3e24343ad2025-06-05WarningsExact identifier
application number: M020
Gleam plus Glow SPF 50. SPF 50 Broad Spectrum Sunscreen UVA-UVB Sheer Glow TintAVOBENZONE, OCTISALATE, AND OCTOCRYLENEMDSolarSciences3e392af6-1401-4a2f-9ba4-e43f0fd0fca12025-06-05WarningsExact identifier
application number: M020
Tint plus Tone SPF 50. SPF 50 Broad Spectrum Sunscreen Sheer Tinted MoisturizerAVOBENZONE, OCTISALATE, AND OCTOCRYLENEMDSolarSciences51bd8962-e85a-4964-9337-2ded6b7d8ac82025-06-05WarningsExact identifier
application number: M020
Hydrating Sheer Lip Balm SPF 30 -Crystal Broad Spectrum SPF 30 UVA-UVB SunscreenAVOBENZONE, OCTISALATE, AND HOMOSALATEMDSolarSciences0f23441c-2399-4a72-9f0a-420d25db78af2025-06-05WarningsExact identifier
application number: M020
Vacation Classic Whip SPF 30 Broad Spectrum SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEVacation Inc.36da165b-bc68-24ff-e063-6294a90a304f2025-06-05WarningsExact identifier
application number: M020
Nemah SPF 30 Mineral C/S Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDENemah, Inc.36da2d94-fa90-b145-e063-6394a90a58542025-06-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76348-598-01763480598011000 g in 1 JUG (76348-598-01) 1000 g2023-04-17NoNoCurrent