NeoStrata Enlighten Skin Brightener

Product NDC: 58414-0019
11-digit product format: 584140019
Labeler code: 58414
Product ID: 58414-0019_59e15d1b-73fa-37e9-e063-6394a90a5d62
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate, Octisalate, and Avobenzone
Dosage form: CREAM
Route: TOPICAL
Labeler: NeoStrata Company Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-12-01
Substance: OCTINOXATE; OCTISALATE; AVOBENZONE
Active strength: 75; 50; 30 mg/g; mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
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
2025-01-11 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	58414-0019-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	58414-0019-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	58414-0019-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	58414-0019-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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: NeoStrata Enlighten Skin Brightener
Brand name suffix: with Sunscreen Broad Spectrum SPF 35
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	75 mg/g
OCTISALATE	50 mg/g
AVOBENZONE	30 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
G63QQF2NOX	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
ed495f18-2f8e-4991-b797-82e9f6fc7acb	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2022-03-08	NeoStrata ® Enlighten Skin Brightener with Sunscreen Broad Spectrum SPF 35
2022-03-08	NeoStrata ® Enlighten Skin Brightener with Sunscreen Broad Spectrum SPF 35
2020-01-31	NeoStrata ® Enlighten Skin Brightener with Sunscreen Broad Spectrum SPF 35
2020-01-31	NeoStrata ® Enlighten Skin Brightener with Sunscreen Broad Spectrum SPF 35

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58414-0019-1	NeoStrata Enlighten Skin Brightenerwith Sunscreen Broad Spectrum SPF 35	40 g in 1 TUBE	CREAM	40		4
58414-0019-1	NeoStrata Enlighten Skin Brightenerwith Sunscreen Broad Spectrum SPF 35	1 in 1 CARTON	CREAM	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58414-0019	NEOSTRATA ENLIGHTEN SKIN BRIGHTENER WITH SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) CREAM [NEOSTRATA COMPANY INC.]	4	Current NDC, Legacy NDC, 2 package rows	20250112_ed495f18-2f8e-4991-b797-82e9f6fc7acb.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 7 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	The Kroger Co.	22aa46af-5d0f-4256-8f45-be06f6627561	2026-08-10	Warnings	Exact identifier application number: M020
Colorescience Total Protection No Show Mineral Body Shield	ZINC OXIDE	Colorescience	52e1f59e-63cb-7480-e063-6394a90ad7c5	2026-08-10	Warnings	Exact identifier application number: M020
Eucerin Radiant Tone Tinted Sunscreen SPF 50	AVOBENZENE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	596a4204-3d29-9023-e063-6294a90ad99e	2026-08-10	Warnings	Exact identifier application number: M020
Journee Firm Riche Broad Spectrum Sunscreen SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Merz North America, Inc.	d4d4bfcf-3674-4847-8ad8-1716a8e821ae	2026-08-10	Warnings	Exact identifier application number: M020
ULTRA VIOLETTE Unblock Screen SPF 50 Sunscreen	BEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDE	Grace and Fire USA Inc.	56ad0dce-410e-9d78-e063-6294a90a1c3e	2026-08-09	Warnings	Exact identifier application number: M020
ORLASKIN SPF50 Antioxidant SoothingComplex Sunscreen	ETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE BUTYL METHOXYDIBENZOYLMETHANE ZINC OXIDE BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE	Guangzhou Yapheon Health Industry Co., Ltd.	552a36ed-7a66-4048-e063-6394a90a09bc	2026-08-08	Warnings	Exact identifier application number: M020
lip balm SPF15( 2533) 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	5870aa44-1375-cdc5-e063-6394a90af4a5	2026-08-07	Warnings	Exact identifier application number: M020
lip balm SPF15( Zinc oxide) 01	ZINC OXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	5871ab1d-cf07-d737-e063-6394a90a58fe	2026-08-07	Warnings	Exact identifier application number: M020
VEIRFOO Brightening Hydrating Antiwrinkle Sunscreen	TITANIUM DIOXIDE, OCTINOXATE	LCM TECHNOLOGY Co., Ltd	4cbbf8aa-8910-b7e7-e063-6294a90a4f07	2026-08-07	Warnings	Exact identifier application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATE	AVOBENZONE, HOMOSALATE, OCTISALATE	Topco Associates LLC	58636012-7e29-7206-e063-6394a90a83e9	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M020
AVOBENZONE, HOMOSALATE, OCTISALATE	AVOBENZONE, HOMOSALATE, OCTISALATE	Topco Associates LLC	5864275d-a480-06f8-e063-6394a90aecab	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M020
Avebonzone, Homosalate, Octisalate	AVEBONZONE, HOMOSALATE, OCTISALATE	Topco Associates LLC	5864881c-c495-1f32-e063-6294a90a1304	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M020
Elta MD UV Daily Peptide Lip Balm SPF 40	ZINC OXIDE	CP Skin Health Group, Inc	945538b5-5745-42cf-b610-0018ca2ec254	2026-08-06	Warnings	Exact identifier application number: M020
Avebonzone, Homosalate, Octisalate	AVEBONZONE, HOMOSALATE, OCTISALATE	Topco Associates LLC	58653d79-8fff-f319-e063-6294a90af7a3	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M020
Avebonzone, Homosalate, Octisalate	AVEBONZONE, HOMOSALATE, OCTISALATE	Topco Associates LLC	5865f0e5-14b2-c4bf-e063-6294a90a4710	2026-08-06	Warnings, Adverse reactions	Exact identifier application number: M020
Stream2Sea Ecostock SPF 40 Sunscreen	ZINC OXIDE	Stream2Sea, LLC	5866e026-a652-3300-e063-6394a90acff0	2026-08-06	Warnings	Exact identifier application number: M020
NHLMA Skin Defense Sunscreen	BROAD SPECTRUM SPF 30	NATIONAL HAIR LOSS LLC	56326ae0-387f-ad08-e063-6294a90acc4f	2026-08-06	Warnings	Exact identifier application number: M020
EltaMD UV Restore	TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	37fee381-ce6b-4949-9a4a-778aa839fb84	2026-08-06	Warnings	Exact identifier application number: M020
Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Kenvue Brands LLC	129ae274-0094-be5e-e063-6394a90a9801	2026-08-05	Warnings	Exact identifier application number: M020
Leader Kids Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CARDINAL HEALTH 110, LLC. DBA LEADER	3636693a-ba81-5d49-e063-6394a90a3006	2026-08-05	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58414-0019-1	58414001901	1 TUBE in 1 CARTON (58414-0019-1) / 40 g in 1 TUBE	1 tube	2018-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NeoStrata ® Enlighten Skin Brightener with Sunscreen Broad Spectrum SPF 35	NeoStrata Company Inc.	2026-08-25	HUMAN OTC DRUG LABEL	5