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 44 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRUST MD SPF30 STEM CELL FACEOCTINOXATE OCTISALATE HOMOSALATE AVOBENZONE TITANIUM DIOXIDEGuangzhou Yapheon Health Industry Co., Ltd.4f2ca12c-bc6f-61b8-e063-6294a90a0d7e2026-04-11WarningsExact identifier
application number: M020
MIDHA Rice Daily Moisture Sun CreamAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMIDHA Cosmetic Co.,Ltd.4b394107-7830-c2c6-e063-6294a90a07d92026-04-10WarningsExact identifier
application number: M020
Abib Dewy tinted sunscreen Glow tube DeepOCTISALATE, OCTOCRYLENE, ZINC OXIDEFOURCOMPANY CO., LTD.4f15d5ba-6396-56bf-e063-6394a90adb062026-04-10WarningsExact identifier
application number: M020
Abib Dewy tinted sunscreen Glow tube LightOCTISALATE, OCTOCRYLENE, ZINC OXIDEFOURCOMPANY CO., LTD.4f165895-aa84-e215-e063-6394a90a62562026-04-10WarningsExact identifier
application number: M020
Abib Dewy tinted sunscreen Glow tube MediumOCTISALATE, OCTOCRYLENE, ZINC OXIDEFOURCOMPANY CO., LTD.4f16b8a4-4279-5f79-e063-6294a90a353d2026-04-10WarningsExact identifier
application number: M020
Sheer Touch Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLCf5ca0416-548c-4be0-a69e-c7e1b52aba952026-04-10Warnings, Adverse reactionsExact identifier
application number: M020
LASPA TINTED MATTE SUNSCREEN SPF 20 LIGHTZINC OXIDEThe Green Cricket Incc56fd135-f46a-51ce-e053-2a95a90ab7b32026-04-10WarningsExact identifier
application number: M020
CorTex SunX 50 ThickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Products Incf67a6c6c-c314-1c9d-e053-2a95a90a7f1a2026-04-10WarningsExact identifier
application number: M020
Nu Skin 180 Degree UV Block Hydrator SPF 18OCTINOXATE AND ZINC OXIDENSE Products, Inc.b9635e59-bb08-4167-b7ba-54c3fc7125892026-04-09WarningsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEThe Kroger Co.79c6fe2a-34c2-44cc-81bc-796c4463d2a62026-04-09Warnings, Adverse reactionsExact identifier
application number: M020
Arizona Sun ProductsSurfblok Lip Balm SPF 15LIP BALMArizona Sun Products11fdbae5-84ec-7b1d-e063-6294a90a28782026-04-09WarningsExact identifier
application number: M020
Arizona Sun Prickly Pear Lip Balm SPF 15SUNSCREEN LIP BALMArizona Sun Products11e9cb25-6ff8-a121-e063-6394a90a849e2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen SPF 8SUNSCREENArizona Sun Products11e8b612-29be-47ed-e063-6394a90ab9e72026-04-09WarningsExact identifier
application number: M020
Arizona Sun ProductsSurfblok Lip Balm SPF 15LIP BALMArizona Sun Products11fdcfd0-8b24-7efc-e063-6294a90af7fa2026-04-09WarningsExact identifier
application number: M020
Arizona Sun SPF 45 Cycleblok SunscreenSUNSCREENArizona Sun Products11e71a84-12d1-2d4f-e063-6294a90adcd62026-04-09WarningsExact identifier
application number: M020
Arizona Sun SPF 45 Bikerblok SunscreenSUNSCREENArizona Sun Products11e6eafd-f967-b748-e063-6394a90aabfd2026-04-09WarningsExact identifier
application number: M020
YSE Beauty Skin Glow Primer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMSS Beauty LLC6a318e27-14e5-488e-ac19-010f69cb743d2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen Kids Water Resistant SPF 30SUNSCREENArizona Sun Products116ed17c-3b38-5e96-e063-6294a90a42462026-04-09WarningsExact identifier
application number: M020
Arizona Sun SPF 45 Surfblok SunscreenSUNSCREENArizona Sun Products11e76815-9316-555d-e063-6294a90aeb812026-04-09WarningsExact identifier
application number: M020
Arizona Sun Moisturizer SPF 3MOISTURIZERArizona Sun Products1171af26-3040-552c-e063-6294a90ae2202026-04-09WarningsExact 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