Home NDC 53675-210-01 Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 50
Product NDC 53675-210
Requested package NDC 53675-210-01
11-digit product format 536750210
Labeler code 53675
Product ID 53675-210_297be25a-30e0-e918-e063-6294a90a384a
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Dosage form CREAM
Route TOPICAL
Labeler Aruba Aloe Balm NV
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-11
Substance AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength 30; 73.4; 100; 50 mg/mL; mg/mL; mg/mL; mg/mL
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 Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 50
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/mL HOMOSALATE 73.4 mg/mL OCTOCRYLENE 100 mg/mL OCTISALATE 50 mg/mL
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 53675-210-01 Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 50 59 mL in 1 TUBE CREAM 59 1 53675-210-02 Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 50 177 mL in 1 TUBE CREAM 177 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53675-210 ARUBA ALOE HYDRATING ALOE RICH SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) CREAM [ARUBA ALOE BALM NV] 1 Current NDC, 2 package rows 20241219_acda1640-0d35-43dc-8734-d47b00cc85ed.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 241 of 352 · 7,030 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53675-210-01 53675021001 59 mL in 1 TUBE (53675-210-01) 59 ml 2024-04-11 No No Current