5298 SUNSCREEN

Product NDC
76138-220
11-digit product format
761380220
Labeler code
76138
Product ID
76138-220_1cee8d76-1f9c-14b4-e063-6294a90afc0e
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octocrylene, Octisalate
Dosage form
LOTION
Route
TOPICAL
Labeler
Innovation Specialties
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-10
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 100; 50; 100 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
5298 SUNSCREEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE100 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE100 mg/mL

Harmonized Identifiers#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76138-220-022024-01-30C16284748780-11030e365-3d99-111a-e063-dadaa90a10e25298 SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76138-220-025298 SUNSCREEN60 mL in 1 BOTTLELOTION603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76138-2205298 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) LOTION [INNOVATION SPECIALTIES]3Current NDC, Legacy NDC, 1 package rows20240712_667dccd6-5047-4beb-b2f0-0b8d8d79aa01.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76138-220-027613802200260 mL in 1 BOTTLE (76138-220-02) 60 ml2022-05-100000-00-00NoNoCurrent