5283 Sunscreen

Product NDC
76138-222
11-digit product format
761380222
Labeler code
76138
Product ID
76138-222_1cee8d76-1faa-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
2023-10-31
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 10; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
5283 Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100mL
HOMOSALATE10 g/100mL
OCTISALATE5 g/100mL
OCTOCRYLENE10 g/100mL

Harmonized Identifiers#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76138-222-015283 Sunscreen30 mL in 1 BOTTLE, PLASTICLOTION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76138-2225283 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) LOTION [INNOVATION SPECIALTIES]2Current NDC, 1 package rows20240712_3a06bb05-5965-4d7d-a299-3d48b163c604.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76138-222-017613802220130 mL in 1 BOTTLE, PLASTIC (76138-222-01) 30 ml2023-10-31NoNoHistorical