FDA.reportPublic FDA data

HERBAL UV DEFENSE SPF40

Product NDC
68577-199
11-digit product format
685770199
Labeler code
68577
Product ID
68577-199_2a76fea4-6ab0-5908-e063-6394a90afe4e
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octisalate, Avobenzone, Octocrylene
Dosage form
GEL
Route
TOPICAL
Labeler
COSMAX USA, CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-03
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 9.5; 5; 2.6 mg/100mg; mg/100mg; mg/100mg; mg/100mg
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HERBAL UV DEFENSE SPF40
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 mg/100mg
HOMOSALATE9.5 mg/100mg
OCTISALATE5 mg/100mg
OCTOCRYLENE2.6 mg/100mg

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-199-00HERBAL UV DEFENSE SPF4030 mg in 1 TUBEGEL301
68577-199-00HERBAL UV DEFENSE SPF401 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-199HERBAL UV DEFENSE SPF40 (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) GEL [COSMAX USA, CORPORATION]1Current NDC, 2 package rows20250101_2a76fd94-2f1f-e6d8-e063-6294a90a287c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68577-199-00685770199001 TUBE in 1 CARTON (68577-199-00) / 30 mg in 1 TUBE1 tube2024-01-03NoNoCurrent