FDA.reportPublic FDA data

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 138 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC31177bbd-68b0-8b24-e063-6294a90aa8d82025-12-10WarningsExact identifier
application number: M020
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC3117e138-83a1-0931-e063-6394a90abe432025-12-10WarningsExact identifier
application number: M020
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC31188175-a4ca-449f-e063-6394a90a3c052025-12-10WarningsExact identifier
application number: M020
COVEREDZINC OXIDEPotency No. 710 LLC3118c3ed-f0f0-f997-e063-6294a90a53a92025-12-10WarningsExact identifier
application number: M020
COVEREDZINC OXIDEPotency No. 710 LLC3117faeb-1792-1b2e-e063-6294a90a92df2025-12-10WarningsExact identifier
application number: M020
Non-Tinted Mineral Foaming SunscreenTITANIUM DIOXIDE, ZINC OXIDERestore Skin Therapy, LLC364b6af2-a0ed-4a17-e063-6394a90a3a172025-12-10Exact identifier
application number: M020
Morning ReplenishZINC OXIDERestore Skin Therapy, LLC364b26c2-a1bb-9660-e063-6294a90a14d12025-12-10Exact identifier
application number: M020
Glass Skin Sunscreen TintedZINC OXIDEFleur de Lune, LLC34288989-35b8-3aa3-e063-6394a90ac2c42025-12-10Exact identifier
application number: M020
Glass Skin Sunscreen TintedZINC OXIDEFleur de Lune, LLC3418394b-fede-65ce-e063-6394a90ad5f92025-12-10Exact identifier
application number: M020
Glass Skin Sunscreen Non-TintedZINC OXIDEFleur de Lune, LLC341871e5-c170-7560-e063-6394a90a8eee2025-12-10Exact identifier
application number: M020
Glass Skin Sunscreen Non-TintedZINC OXIDEFleur de Lune, LLC3428bdbb-1f18-a29b-e063-6294a90addbc2025-12-10Exact identifier
application number: M020
Sheer Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342b2403-4f4a-3e77-e063-6294a90a4f0a2025-12-10Exact identifier
application number: M020
Sheer Mineral Sunscreen BarTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342b69d5-f0e1-99cd-e063-6294a90abb6e2025-12-10Exact identifier
application number: M020
Sheer Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342c3f42-c17f-f777-e063-6394a90a80582025-12-10Exact identifier
application number: M020
Lip SPFTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396d3fdd-99d8-77e8-e063-6294a90aec2f2025-12-10Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396cae82-7641-e1b2-e063-6394a90a7c072025-12-10Exact identifier
application number: M020
Solar Knight SPF 40 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDEMASCARENAS ENTERPRISES, INC.36c27c91-22ac-205c-e063-6294a90ab3792025-12-10Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396ce15a-06ad-4055-e063-6294a90a27fb2025-12-10Exact identifier
application number: M020
Dermablue Daily ReplenishingZINC OXIDEDermablue, P.C.308da9c9-544e-d5d1-e063-6294a90aa49b2025-12-10WarningsExact identifier
application number: M020
Recoverie Mineral MatteZINC OXIDEClear Day Acne Clinic308f41de-fb14-40f9-e063-6394a90a008f2025-12-10WarningsExact 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