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 147 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mineral Based Foam Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 32465271-abb9-d03f-e063-6294a90a990e 2025-12-08 Exact identifier application number: M020 Mineral Based Foam Sunscreen Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 32486bfb-0cc8-0283-e063-6394a90a9967 2025-12-08 Exact identifier application number: M020 Harrys Daily Facial SPF Broad Spectrum ZINC OXIDE Harry's, Inc. 39fdde34-45ec-bc22-e063-6394a90a7dce 2025-12-08 Warnings Exact identifier application number: M020 Healthy Mineral Sunscreen Brightening plus Tint ZINC OXIDE ZEN DERMATOLOGY, INC. 31e32e9c-9e0b-b678-e063-6294a90a66f5 2025-12-08 Exact identifier application number: M020 Healthy Mineral Sunscreen No Shine plus Tint ZINC OXIDE Zen Dermatology, Inc. 31576340-cb11-d944-e063-6294a90adef2 2025-12-08 Warnings Exact identifier application number: M020 Healthy Mineral Sunscreen No Shine - No Tint TITANIUM DIOXIDE, ZINC OXIDE Zen Dermatology, Inc. 31572a16-5f60-565f-e063-6394a90ab8c9 2025-12-08 Warnings Exact identifier application number: M020 Healthy Mineral Sunscreen Face and Body ZINC OXIDE Zen Dermatology, Inc. 31e376b4-098f-34d7-e063-6394a90a1772 2025-12-08 Exact identifier application number: M020 AcneFix Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ACNEFIX INC. 315894b7-ac1b-0982-e063-6294a90ab879 2025-12-08 Exact identifier application number: M020 Shunly Natural Cover SPF50 TITANIUM DIOXIDE, ZINC OXIDE Shunly Skin Care a64e373b-b3f6-4024-b5f5-253783485cd6 2025-12-08 Warnings Exact identifier application number: M020 AcneFix Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ACNEFIX INC. 31583c7e-365a-d899-e063-6394a90aa63f 2025-12-08 Exact identifier application number: M020 Mineral Fusion Tinted TITANIUM DIOXIDE, ZINC OXIDE FOREFRONT DERMATOLOGY, S.C. 334ec844-5560-50f7-e063-6394a90a01be 2025-12-08 Exact identifier application number: M020 Mineral Fusion Tinted TITANIUM DIOXIDE, ZINC OXIDE FOREFRONT DERMATOLOGY, S.C. 334f90d6-68e5-db37-e063-6294a90a5fb1 2025-12-08 Exact identifier application number: M020 Skin Apeel Pure Protect SPF 40 Broad Spectrum ZINC OXIDE Skin Apeel, Inc. 18e78c7f-1523-a4f4-e063-6394a90aed97 2025-12-08 Warnings Exact identifier application number: M020 Silk Screen TITANIUM DIOXIDE, ZINC OXIDE Skin Apeel, Inc. 3c44baf4-9555-faad-e063-6294a90ab24f 2025-12-08 Warnings Exact identifier application number: M020 Glow Stick TITANIUM DIOXIDE, ZINC OXIDE Skin Apeel, Inc. 3c54b857-c017-a953-e063-6394a90a38df 2025-12-08 Warnings Exact identifier application number: M020 Lip Shield TITANIUM DIOXIDE, ZINC OXIDE Skin Apeel, Inc. 3c545e55-3f55-842b-e063-6394a90ae48e 2025-12-08 Warnings Exact identifier application number: M020 Bare Barrier Sport TITANIUM DIOXIDE, ZINC OXIDE Skin Apeel, Inc. 3c580794-eda3-de57-e063-6294a90a0303 2025-12-08 Warnings Exact identifier application number: M020 Flawless Brightening Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Flawless Skin Care LLC 312e9ca0-a388-a546-e063-6294a90a15d6 2025-12-08 Warnings Exact identifier application number: M020 Mineral SPF 40, protect TITANIUM DIOXIDE, ZINC OXIDE Acne Specialists LLC 2f8859cf-8277-6ea9-e063-6294a90a1a75 2025-12-08 Warnings Exact identifier application number: M020 Mineral SPF 40, Tinted TITANIUM DIOXIDE, ZINC OXIDE Acne Specialists LLC 2fb19ed7-8cee-ce80-e063-6394a90ad3dc 2025-12-08 Warnings Exact identifier application number: M020
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