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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
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 packagepackage58414-0019-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage58414-0019-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage58414-0019-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage58414-0019-1IInactivated by FDA9bebd1f3094a…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
IngredientStrength
OCTINOXATE75 mg/g
OCTISALATE50 mg/g
AVOBENZONE30 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ed495f18-2f8e-4991-b797-82e9f6fc7acbAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58414-0019-1NeoStrata Enlighten Skin Brightenerwith Sunscreen Broad Spectrum SPF 3540 g in 1 TUBECREAM404
58414-0019-1NeoStrata Enlighten Skin Brightenerwith Sunscreen Broad Spectrum SPF 351 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58414-0019NEOSTRATA ENLIGHTEN SKIN BRIGHTENER WITH SUNSCREEN BROAD SPECTRUM SPF 35 (OCTINOXATE, OCTISALATE, AND AVOBENZONE) CREAM [NEOSTRATA COMPANY INC.]4Current NDC, Legacy NDC, 2 package rows20250112_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 44 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Arizona Sun Sunscreen SPF15SUNSCREENArizona Sun10a600aa-4faa-47fc-e063-6294a90ac4ef2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen Water Resistant SPF 30SUNSCREENArizona Sun Products11334e45-4bc2-d597-e063-6294a90a323e2026-04-09WarningsExact identifier
application number: M020
Arizona Sun Sunscreen Water Resistant SPF 30SUNSCREENArizona Sun Products1148e719-b8ed-11b3-e063-6394a90ac1162026-04-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58414-0019-1584140019011 TUBE in 1 CARTON (58414-0019-1) / 40 g in 1 TUBE1 tube2018-12-010000-00-00NoNoCurrent