SUMMER GELEE SPF-4

Product NDC
84281-476
11-digit product format
842810476
Labeler code
84281
Product ID
84281-476_171b4cde-2e02-0bb4-e063-6394a90a9deb
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE, OCTISALATE
Dosage form
GEL
Route
TOPICAL
Labeler
SUMMER GELEE LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-06
Substance
HOMOSALATE; OCTISALATE
Active strength
20; 20 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
SUMMER GELEE SPF-4
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE20 mg/mL
OCTISALATE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV06SV4M95S, 4X49Y0596W

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84281-476-00SUMMER GELEE SPF-492.26 mL in 1 TUBEGEL92.261

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84281-476SUMMER GELEE SPF-4 (HOMOSALATE, OCTISALATE) GEL [SUMMER GELEE LLC]1Current NDC, 1 package rows20240507_c9ec81ad-0478-4026-bc6c-5582eb012b8d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84281-476-008428104760092.26 mL in 1 TUBE (84281-476-00) 92.26 ml2024-05-06NoNoCurrent