FDA.reportPublic FDA data

Cover FX Invisible Primer SPF30

Product NDC
68577-105
11-digit product format
685770105
Labeler code
68577
Product ID
68577-105_2a272a9c-d469-2e6b-e063-6294a90addb6
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form
LOTION
Route
TOPICAL
Labeler
Cosmax Usa, Corporation
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-28
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 100; 50; 26 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cover FX Invisible Primer SPF30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE100 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE26 mg/mL

Harmonized Identifiers#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-105-00Cover FX Invisible Primer SPF3030 mL in 1 TUBELOTION305
68577-105-00Cover FX Invisible Primer SPF301 in 1 CARTONLOTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-105COVER FX INVISIBLE PRIMER SPF30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [COSMAX USA, CORPORATION]5Current NDC, 2 package rows20241228_2983dd7c-7ca7-e952-e063-6394a90a3098.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68577-105-00685770105001 TUBE in 1 CARTON (68577-105-00) / 30 mL in 1 TUBE1 tube2023-04-28NoNoHistorical