Home NDC 61477-225 ALOE KOTE
Product NDC 61477-225
11-digit product format 614770225
Labeler code 61477
Product ID 61477-225_495014ec-e473-983c-e063-6294a90a4c89
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE, OXYBENZONE, HOMOSALATE
Dosage form CREAM
Route TOPICAL
Labeler Aloe Care International, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-05-17
Substance OCTINOXATE; HOMOSALATE; OXYBENZONE
Active strength 7.4; 14.5; 5.9 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 61477-225-11 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 61477-225-11 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 KOTE
Brand name suffix SPF 25
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 7.4 g/100g HOMOSALATE 14.5 g/100g OXYBENZONE 5.9 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 Internal UNII lookup V06SV4M95S Internal UNII lookup 95OOS7VE0Y Internal UNII lookup
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 61477-225-11 ALOE KOTESPF 25 7 g in 1 JAR CREAM 7 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61477-225 ALOE KOTE SPF 25 (OCTINOXATE, OXYBENZONE, HOMOSALATE) CREAM [ALOE CARE INTERNATIONAL, LLC] 6 Current NDC, Legacy NDC, 1 package rows 20240214_12e78c53-ba19-4c8e-bd2f-8c85fccbc179.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 138 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SHADED TITANIUM DIOXIDE, ZINC OXIDE Potency No. 710 LLC 3117e138-83a1-0931-e063-6394a90abe43 2025-12-10 Warnings Exact identifier application number: M020 SHADED TITANIUM DIOXIDE, ZINC OXIDE Potency No. 710 LLC 31188175-a4ca-449f-e063-6394a90a3c05 2025-12-10 Warnings Exact identifier application number: M020 COVERED ZINC OXIDE Potency No. 710 LLC 3118c3ed-f0f0-f997-e063-6294a90a53a9 2025-12-10 Warnings Exact identifier application number: M020 COVERED ZINC OXIDE Potency No. 710 LLC 3117faeb-1792-1b2e-e063-6294a90a92df 2025-12-10 Warnings Exact identifier application number: M020 Non-Tinted Mineral Foaming Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Restore Skin Therapy, LLC 364b6af2-a0ed-4a17-e063-6394a90a3a17 2025-12-10 Exact identifier application number: M020 Morning Replenish ZINC OXIDE Restore Skin Therapy, LLC 364b26c2-a1bb-9660-e063-6294a90a14d1 2025-12-10 Exact identifier application number: M020 Glass Skin Sunscreen Tinted ZINC OXIDE Fleur de Lune, LLC 34288989-35b8-3aa3-e063-6394a90ac2c4 2025-12-10 Exact identifier application number: M020 Glass Skin Sunscreen Tinted ZINC OXIDE Fleur de Lune, LLC 3418394b-fede-65ce-e063-6394a90ad5f9 2025-12-10 Exact identifier application number: M020 Glass Skin Sunscreen Non-Tinted ZINC OXIDE Fleur de Lune, LLC 341871e5-c170-7560-e063-6394a90a8eee 2025-12-10 Exact identifier application number: M020 Glass Skin Sunscreen Non-Tinted ZINC OXIDE Fleur de Lune, LLC 3428bdbb-1f18-a29b-e063-6294a90addbc 2025-12-10 Exact identifier application number: M020 Sheer Facial Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE BB MEDICAL & DERMATOLOGY INC 342b2403-4f4a-3e77-e063-6294a90a4f0a 2025-12-10 Exact identifier application number: M020 Sheer Mineral Sunscreen Bar TITANIUM DIOXIDE, ZINC OXIDE BB MEDICAL & DERMATOLOGY INC 342b69d5-f0e1-99cd-e063-6294a90abb6e 2025-12-10 Exact identifier application number: M020 Sheer Facial Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE BB MEDICAL & DERMATOLOGY INC 342c3f42-c17f-f777-e063-6394a90a8058 2025-12-10 Exact identifier application number: M020 Lip SPF TITANIUM DIOXIDE, ZINC OXIDE FRANCISCO FLORES, M.D., P.A. 396d3fdd-99d8-77e8-e063-6294a90aec2f 2025-12-10 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE FRANCISCO FLORES, M.D., P.A. 396cae82-7641-e1b2-e063-6394a90a7c07 2025-12-10 Exact identifier application number: M020 Solar Knight SPF 40 Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE MASCARENAS ENTERPRISES, INC. 36c27c91-22ac-205c-e063-6294a90ab379 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE FRANCISCO FLORES, M.D., P.A. 396ce15a-06ad-4055-e063-6294a90a27fb 2025-12-10 Exact identifier application number: M020 Dermablue Daily Replenishing ZINC OXIDE Dermablue, P.C. 308da9c9-544e-d5d1-e063-6294a90aa49b 2025-12-10 Warnings Exact identifier application number: M020 Recoverie Mineral Matte ZINC OXIDE Clear Day Acne Clinic 308f41de-fb14-40f9-e063-6394a90a008f 2025-12-10 Warnings Exact identifier application number: M020 AL0043600 Alba Botanica VE Herbal Healing Body COLLOIDAL OATMEAL The Hain Celestial Group, Inc. 60672feb-141f-651e-e053-2a91aa0af41d 2025-12-10 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 61477-225-11 61477022511 7 g in 1 JAR (61477-225-11) 7 g 2019-05-17 0000-00-00 No No Current