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 date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76348-598-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76348-598-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76348-598-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76348-598-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`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
Ingredient	Strength
ZINC OXIDE	17.5 g/1000g
OCTINOXATE	70 g/1000g
OCTISALATE	10 g/1000g
TITANIUM DIOXIDE	12.5 g/1000g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
15FIX9V2JP	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f953302e-f712-129a-e053-6294a90ab9a8	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76348-598-01	2025-03-13	C162847	48780-1	2cef2736-85b3-d83d-e063-dadaa90ab31f	Impact Melanoma SPF 30
76348-598-01	2025-01-30	C162847	48780-1	2cef2736-85b3-d83d-e063-dadaa90ab31f	Impact Melanoma SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76348-598-01	Impact Melanoma SPF 30	1000 g in 1 JUG	LOTION	1000		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76348-598	IMPACT MELANOMA SPF 30 (ZINC OXIDE) LOTION [RENU LABORATORIES, LLC]	2	Current NDC, 1 package rows	20250316_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 322 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
YOU-V SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	YouV, LLC	290cd617-aa90-4f10-8a1d-d8954b927004	2023-11-11	Warnings	Exact identifier application number: M020
BEAST SPIT and POLISH FACE SPF-20	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Small Batch Beauty, LLC	27e5244b-4b69-4dec-9dd5-ba8b71b171b2	2023-11-11	Warnings	Exact identifier application number: M020
SEVEN MINERALS Skin Friendly SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Seven Minerals NA LLC	bd60cf89-e0e9-48ad-b174-1ecf72557d9c	2023-11-11	Warnings	Exact identifier application number: M020
OUTER REEF Reef Safe (WR) Broad Spectrum SPF 30	TITANIUM DIOXIDE	Coral Reef Park Co., Inc.	743f3d23-0f5c-4724-9f69-411c109506e1	2023-11-11	Warnings	Exact identifier application number: M020
SEVEN MINERALS Skin Friendly SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Seven Minerals NA LLC	6d6b5b2a-210a-4606-9cdb-f6eec10f37e8	2023-11-11	Warnings	Exact identifier application number: M020
KISS MY FACE SPF-50 Baby Mineral Sunscreen	ZINC OXIDE	WINDMILL HEALTH PRODUCTS LLC	ac66ad82-a01f-4e44-92a7-b5ab5bd30922	2023-11-11	Warnings	Exact identifier application number: M020
KISS MY FACE SPF-50 Daily Mineral Sunscreen	ZINC OXIDE	WINDMILL HEALTH PRODUCTS LLC	1745dc35-648e-4315-a285-c99ebeef4f6a	2023-11-11	Warnings	Exact identifier application number: M020
KISS MY FACE SPF-50 Face Factor Mineral Sunscreen	ZINC OXIDE	WINDMILL HEALTH PRODUCTS LLC	edc2c1e7-e1a8-4b49-96df-8a94eb6a242a	2023-11-11	Warnings	Exact identifier application number: M020
ONCODERM Rx Mineral Sunscreen SPF-30	TITANIUM DIOXIDE, ZINC OXIDE	Oncoderm, LLC	9f16e832-067c-4ae8-bd7d-6f0dc0ad6fae	2023-11-11	Warnings	Exact identifier application number: M020
SEAWEED BATH CO. SPF 50 SPORT	OCTOCRYLENE, ZINC OXIDE, OCTISALATE	The Seaweed Bath Co.	f01516bf-8aed-4402-a3f9-ef11c54d46b3	2023-11-11	Warnings	Exact identifier application number: M020
SEAWEED BATH CO. SPF-30	OCTOCRYLENE, ZINC OXIDE, OCTISALATE	The Seaweed Bath Co.	4df55434-fb9a-442d-82cf-16a4957f0a2a	2023-11-11	Warnings	Exact identifier application number: M020
PROJECT REEF Mineral Sunscreen SPF-30	ZINC OXIDE	Project Reef LLC	b7de9ec2-6db1-4c89-b734-15c4bd5c3251	2023-11-11	Warnings	Exact identifier application number: M020
SEAWEED BATH CO Cooling Mist SPF-60 Sport	HOMOSALATE, OCTISALATE, ZINC OXIDE	The Seaweed Bath Co.	98ccbb70-6e1a-4e92-a095-cbc4be12fcbf	2023-11-11	Warnings	Exact identifier application number: M020
PROJECT REEF Mineral Sunscreen SPF-50	ZINC OXIDE, TITANIUM DIOXIDE	Project Reef LLC	87b9170c-956e-4aa2-9416-da00cca81b58	2023-11-11	Warnings	Exact identifier application number: M020
YOUTH CORRIDOR Soothe and Defend SPF-30	OCTOCRYLENE, OCTISALATE, ZINC OXIDE	Youth Corridor	5c0873ff-8e76-48de-919d-f69794c4bd37	2023-11-11	Warnings	Exact identifier application number: M020
ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50)	HOMOSALATE, OCTINOXATE, OCTISALATE, ZINC OXIDE	ZITSTICKA, Inc	32164318-7a7e-40b2-99da-8246c99fdbd3	2023-11-11	Warnings	Exact identifier application number: M020
SUNNY Q Broad Spectrum SPF-30	ZINC OXIDE	Sunny Q Sunscreen LLC	593870fa-425c-401c-ac26-f63f4ce0298f	2023-11-11	Warnings	Exact identifier application number: M020
BRICKELL Daily Defense Face Moisturizer SPF-20	OCTISALATE, ZINC OXIDE	BRICKELL BRANDS LLC	44806b83-9220-4d34-806d-20cf0a47186e	2023-11-11	Warnings	Exact identifier application number: M020
BRICKELL Element Defense Moisturizer SPF-45	OCTOCRYLENE, OCTISALATE, ZINC OXIDE	BRICKELL BRANDS LLC	94be278a-3773-469b-8e40-3242d1072a3d	2023-11-11	Warnings	Exact identifier application number: M020
I KNOW Very Necessary Broad Spectrum SPF-40 Moisturizing Cream	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Thirty7 LLC	6ff00b6e-1cc7-4cc4-842b-4e379f75e454	2023-11-11	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76348-598-01	76348059801	1000 g in 1 JUG (76348-598-01)	1000 g	2023-04-17	No	No	Current