Home NDC 53675-208-00 Aruba Aloe broad spectrum SPF 15 Lip sunscreen and Moisturizer
Product NDC 53675-208
Requested package NDC 53675-208-00
11-digit product format 536750208
Labeler code 53675
Product ID 53675-208_0eae7a1b-f5ac-eb4a-e063-6394a90af2c5
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Dosage form STICK
Route TOPICAL
Labeler Aruba Aloe Balm NV
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-14
Substance AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength 30; 73.4; 50; 50 mg/g; mg/g; mg/g; mg/g
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 broad spectrum SPF 15 Lip sunscreen and Moisturizer
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/g HOMOSALATE 73.4 mg/g OCTOCRYLENE 50 mg/g OCTISALATE 50 mg/g
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 53675-208-00 Aruba Aloe broad spectrum SPF 15 Lip sunscreen and Moisturizer 4.8 g in 1 PACKAGE STICK 4.8 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53675-208 ARUBA ALOE BROAD SPECTRUM SPF 15 LIP SUNSCREEN AND MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) STICK [ARUBA ALOE BALM NV] 1 Current NDC, 1 package rows 20240112_9e3ed6dc-14ba-4bb2-a633-1a1fe92099ce.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 238 of 346 · 6,912 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53675-208-00 53675020800 4.8 g in 1 PACKAGE (53675-208-00) 4.8 g 2023-12-14 No No Current