Home NDC 61477-224 ALOE UP MEDICATED LIP BALM
Product NDC 61477-224
11-digit product format 614770224
Labeler code 61477
Product ID 61477-224_49a26858-d4e3-a984-e063-6294a90a5803
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Dosage form LIPSTICK
Route TOPICAL
Labeler Aloe Care International, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-05-17
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength 2; 7.5; 5; 2.5; 6 g/100g; g/100g; g/100g; g/100g; g/100g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 61477-224-11 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 61477-224-11 bd6a592717d7…303034d00443…
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 ALOE UP MEDICATED LIP BALM
Brand name suffix SPF 30
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 2 g/100g HOMOSALATE 7.5 g/100g OCTISALATE 5 g/100g OCTOCRYLENE 2.5 g/100g OXYBENZONE 6 g/100g
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61477-224-11 ALOE UP MEDICATED LIP BALMSPF 30 4.25 g in 1 TUBE LIPSTICK 4.25 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61477-224 ALOE UP MEDICATED LIP BALM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LIPSTICK [ALOE CARE INTERNATIONAL, LLC] 7 Current NDC, Legacy NDC, 1 package rows 20240215_859b6d3f-b1ca-4966-8f0c-f9afa0d5864c.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 Marketing end Sample Exclude flag Status 61477-224-11 61477022411 4.25 g in 1 TUBE (61477-224-11) 4.25 g 2019-05-17 0000-00-00 No No Current