Impact Melanoma SPF 30

Product NDC
76348-598
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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76348-598-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76348-598-01UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76348-598-01UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76348-598-01UExcluded 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 196 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEAruba Aloe Balm NV6a398dad-2fb9-4cdb-86c5-2a392b88f29b2025-08-13WarningsExact identifier
application number: M020
SM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 40ZINC OXIDEALL THE RAJE, LLC9ffbd53b-1295-42b4-9cd5-18cbb75921d02025-08-13WarningsExact identifier
application number: M020
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 02 Umber, BistreZINC OXIDEPower Beauty Co.2e6eac42-0b70-44ea-e063-6294a90a49f82025-08-13WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE/OCTOCRYLENE/OXYBENZONEEdgewell Personal Care Brands LLC3c414e9b-6c3e-2c8d-e063-6394a90af4a62025-08-13WarningsExact identifier
application number: M020
Earth Mama Baby Mineral Sunscreen SPF 40ZINC OXIDEEleeo Brands LLC3c443347-0134-8c87-e063-6294a90a80462025-08-13WarningsExact identifier
application number: M020
Earth Mama Baby Face Mineral Sunscreen Stick SPF 40ZINC OXIDEEleeo Brands LLC3a22f0b9-2d6d-6230-e063-6294a90adf312025-08-13WarningsExact identifier
application number: M020
Earth Mama Lady Face Tinted Mineral Sunscreen Stick SPF 40ZINC OXIDEEleeo Brands LLC3c4567d6-879e-f995-e063-6394a90a319f2025-08-13WarningsExact identifier
application number: M020
Silk ScreenTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c457455-b9b1-546b-e063-6294a90a41f62025-08-13WarningsExact identifier
application number: M020
Earth Mama Tinted Mineral Sunscreen SPF 40ZINC OXIDEEleeo Brands LLC3c455d29-df4e-f4d5-e063-6394a90a97ba2025-08-13WarningsExact identifier
application number: M020
Baby Bum Mineral 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3c470ff8-37d6-a729-e063-6294a90aa5252025-08-13WarningsExact identifier
application number: M020
Sun Bum 50 Mineral Sunscreen 1 OZZINC OXIDESun Bum, LLC3c483d04-8942-5269-e063-6294a90a38812025-08-13WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE/OCTOCRYLENE/OXYBENZONEEdgewell Personal Care Brands LLC3c49c623-47c6-4dc9-e063-6294a90a00962025-08-13WarningsExact identifier
application number: M020
100% MINERAL SUNSCREEN100% MINERAL SUNSCREENGuangzhou Pallas Cosmetics Co.,Ltd.3c4a3b41-9183-3835-e063-6394a90aea612025-08-13WarningsExact identifier
application number: M020
ERBORIAN CC CREME Color Correcting SPF 25 FAIROCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L4443d4e6-bdc9-4547-9189-e94e9e0bdd2d2025-08-12WarningsExact identifier
application number: M020
ERBORIAN CC Red Correct Color Correcting SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&La6cd16cc-5fe3-41b5-b724-83e469cd4d5e2025-08-12WarningsExact identifier
application number: M020
ERBORIAN CC CREME Color Correcting SPF 25 BRONZEOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L4aa12cf0-0c48-4b40-9c9a-bd50523cce8a2025-08-12WarningsExact identifier
application number: M020
ERBORIAN CC CREME Color Correcting SPF 25 MEDIUMOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L5bdaa149-47aa-40ac-b17a-ea6d290998622025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1dda967c-2d69-8948-e063-6294a90ad2a42025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 15mL with wild Rosella SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD24e9a9b8-41ba-123a-e063-6394a90a73cb2025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1dd9fe59-9e40-fd06-e063-6394a90a4ca22025-08-12WarningsExact 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