SUMMER GELEE SPF-30

Product NDC
84281-477
11-digit product format
842810477
Labeler code
84281
Product ID
84281-477_171b43a9-7f61-f8ff-e063-6294a90ab5fb
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form
GEL
Route
TOPICAL
Labeler
SUMMER GELEE LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-06
Substance
HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
100; 50; 50 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
SUMMER GELEE SPF-30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE100 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV06SV4M95S, 4X49Y0596W, 5A68WGF6WM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84281-477-00SUMMER GELEE SPF-3092.26 mL in 1 TUBEGEL92.261

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84281-477SUMMER GELEE SPF-30 (HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [SUMMER GELEE LLC]1Current NDC, 1 package rows20240507_bc85db65-2acc-4b39-9189-f8916c487b61.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84281-477-008428104770092.26 mL in 1 TUBE (84281-477-00) 92.26 ml2024-05-06NoNoCurrent