Home NDC 58331-075-01 Degil Sun SPF 50 Sunscreen
Product NDC 58331-075
Requested package NDC 58331-075-01
11-digit product format 583310075
Labeler code 58331
Product ID 58331-075_155aa0c5-6404-ee86-e063-6294a90a1c4d
Type HUMAN OTC DRUG
Nonproprietary name HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE
Dosage form LOTION
Route TOPICAL
Labeler Degil Safety Products (1989) Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-01
Substance OCTISALATE; AVOBENZONE; OXYBENZONE; OCTOCRYLENE; HOMOSALATE
Active strength 5; 3; 4; 7; 13 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2027-12-31
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 Degil Sun SPF 50 Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTISALATE 5 g/100mL AVOBENZONE 3 g/100mL OXYBENZONE 4 g/100mL OCTOCRYLENE 7 g/100mL HOMOSALATE 13 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58331-075-01 Degil Sun SPF 50 Sunscreen 120 mL in 1 BOTTLE LOTION 120 1 58331-075-03 Degil Sun SPF 50 Sunscreen 750 mL in 1 BOTTLE LOTION 750 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58331-075 DEGIL SUN SPF 50 SUNSCREEN (HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) LOTION [DEGIL SAFETY PRODUCTS (1989) INC] 1 Current NDC, 2 package rows 20240501_155aa0c5-6403-ee86-e063-6294a90a1c4d.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 45 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 58331-075-01 58331007501 120 mL in 1 BOTTLE (58331-075-01) 120 ml 2024-05-06 No No Current