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 30 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SP-FFC3-L0TN Barrier Protection Hydrating Mineral Face Sunscreen	BARRIER PROTECTION HYDRATING MINERAL FACE SUNSCREEN	Epic Etailers, LLC (DBA: Beauty by Earth)	5078479e-a196-7e4d-e063-6394a90ab266	2026-05-19	Warnings	Exact identifier application number: M020
InvisibleMatteBarrierDefenseCeramideSunscreenSerumSPF30SP-FSRM-N0TT	INVISIBLE MATTE BARRIER DEFENSE CERAMIDE SUNSCREEN SERUM SPF 30	Epic Etailers, LLC (DBA: Beauty by Earth)	50790945-f359-07c8-e063-6294a90a5af9	2026-05-19	Warnings	Exact identifier application number: M020
Sun Bum Amazon 8 OZ SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum	522fc8a4-ce9f-8be8-e063-6294a90aebf0	2026-05-19	Warnings	Exact identifier application number: M020
Timesavvy Hybrid Sheer Sun Serum Broad Spectrum SPF 50	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	PROBETTER USA INC.	66624df4-cb6c-4cfb-bbbe-9f885f2ad778	2026-05-18	Warnings	Exact identifier application number: M020
Hampton Sun SPF 50	AVOBENZONE 3.00 % OCTISALATE 5.00 % HOMOSALATE 10.00 %	S&C Hampton Sun LLC	4df050f9-1185-4ee4-a0cd-84ba9d254e58	2026-05-18		Exact identifier application number: M020
Hampton Sun SPF 70 Kids	AVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENE	S&C Hampton Sun LLC	7c976082-3265-4c0b-9985-277d27988895	2026-05-18	Warnings	Exact identifier application number: M020
Evereden Kids Cooling Mineral Sunstick SPF30	ZINC OXIDE	Eden Brands Inc.	521afa81-737f-81d4-e063-6394a90ad307	2026-05-18	Warnings	Exact identifier application number: M020
cle de peau BEAUTE RESTORATIVE DAY SUPREME	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Shiseido Americas Corporation	157e52c5-f6fa-430b-bbb8-86b7c0868ad3	2026-05-18	Warnings	Exact identifier application number: M020
cle de peau BEAUTE SKIN BEAUTY ENHANCER	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	Shiseido Americas Corporation	bc6230f1-dba2-4418-b48c-c5e67aebd1bd	2026-05-18	Warnings	Exact identifier application number: M020
Hampton Sun SPF 30 SILK BODY	AVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENE	S&C Hampton Sun LLC	ed0c184d-473a-4c4c-b6ec-e1d79ad58460	2026-05-18	Warnings	Exact identifier application number: M020
Sheer Defense Tinted SPF 46	ZINC OXIDE, OCTINOXATE	Private Label Skin Care	017265e9-31e6-43ce-9432-cb88f471c496	2026-05-18	Warnings	Exact identifier application number: M020
Aveeno Daily Moisturizing Face Sunscreen Broad Spectrum SPF30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	51d59378-df72-e438-e063-6294a90a97f1	2026-05-15	Warnings	Exact identifier application number: M020
Natural Sense SPF 50 Sunscreen	SUNSCREEN	Dr. Natural LLC	49a2430e-c15b-4610-e063-6294a90ac520	2026-05-15	Warnings	Exact identifier application number: M020
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUM	TITANIUM DIOXIDE AND ZINC OXIDE	LOreal USA Products Inc.	23cc5ff4-f842-4e3e-ac5c-23dbaf7d3914	2026-05-15	Warnings	Exact identifier application number: M020
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUM	TITANIUM DIOXIDE AND ZINC OXIDE	SICOS ET CIE	c688f8e6-2cd2-40db-b03f-90fd74c2d89c	2026-05-15	Warnings	Exact identifier application number: M020
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	7df9dbd2-7db9-4961-819d-e93d14a065c3	2026-05-15	Warnings	Exact identifier application number: M020
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	20efd5fa-3077-4fd4-82d0-ddca946e4528	2026-05-15	Warnings	Exact identifier application number: M020
Target Up and Up Ultra Light Dry-Touch SPF 70 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	51de3d0b-2721-92d3-e063-6394a90a18bb	2026-05-15	Warnings	Exact identifier application number: M020
MELAO Hydrating Lightweight Sunscreen	OCTOCRYLENE,HOMOSALATE,ETHYLHEXYL SALICYLATE,PHENYLBENZIMIDAZOLE SULFONIC ACID,BUTYL METHOXYDIBENZOYLMETHANE,TITANIUM DIOXIDE	Guangdong Aimu Biological Technology Co., Ltd	51c353cb-94c4-e110-e063-6394a90a497e	2026-05-14	Warnings	Exact identifier application number: M020
Hampton Sun SPF 8 Bronze Sunscreen	HOMOSALATE 7.5%, OCTISALATE 5.00%, AVOBENZONE 3.00%	S&C Hampton Sun LLC	7cf4d943-be6e-4e38-8891-1e0b22af5536	2026-05-14	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