NeoStrata Enlighten Skin Brightener

Product NDC
58414-0019
11-digit product format
584140019
Labeler code
58414
Product ID
58414-0019_2b59538b-e516-a18d-e063-6394a90aeeab
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
AVOBENZONE; OCTINOXATE; OCTISALATE
Active strength
30; 75; 50 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NeoStrata Enlighten Skin Brightener
Brand name suffix
with Sunscreen Broad Spectrum SPF 35
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
OCTINOXATE75 mg/g
OCTISALATE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, 4Y5P7MUD51, 4X49Y0596W

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

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