Home NDC 76138-222 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; OCTOCRYLENE; OCTISALATE
Active strength 3; 10; 10; 5 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base 5283 Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3 g/100mL HOMOSALATE 10 g/100mL OCTOCRYLENE 10 g/100mL OCTISALATE 5 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76138-222-01 5283 Sunscreen 30 mL in 1 BOTTLE, PLASTIC LOTION 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76138-222 5283 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) LOTION [INNOVATION SPECIALTIES] 2 Current NDC, 1 package rows 20240712_3a06bb05-5965-4d7d-a299-3d48b163c604.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76138-222-01 76138022201 30 mL in 1 BOTTLE, PLASTIC (76138-222-01) 30 ml 2023-10-31 No No Current