Home NDC 61477-204 ALOE ICE
Product NDC 61477-204
11-digit product format 614770204
Labeler code 61477
Product ID 61477-204_497ad0ff-be39-2cf7-e063-6394a90a7274
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Dosage form SPRAY
Route TOPICAL
Labeler Aloe Care International, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-02-24
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength 3; 10; 5; 2.75; 4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
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 · 24 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61477-204-14 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61477-204-14 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61477-204-14 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61477-204-14 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61477-204-14 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61477-204-14 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61477-204-14 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61477-204-14 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61477-204-14 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 61477-204-14 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 61477-204-14 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 61477-204-14 557ba5c1ecfa…9c80585c8c6e…
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 ICE
Brand name suffix SPF 50
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3 g/100mL HOMOSALATE 10 g/100mL OCTISALATE 5 g/100mL OCTOCRYLENE 2.75 g/100mL OXYBENZONE 4 g/100mL
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 61477-204-26 ALOE ICESPF 50 177 mL in 1 BOTTLE, SPRAY SPRAY 177 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61477-204 ALOE ICE SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [ALOE CARE INTERNATIONAL, LLC] 6 Current NDC, Legacy NDC, 1 package rows 20240214_e4b861d2-3680-4ed7-8650-d1d839da5ab2.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 115 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Non Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION 36c00301-ee41-333c-e063-6294a90a61d5 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION 36c078fa-05f9-ad80-e063-6394a90af3bb 2025-12-16 Exact identifier application number: M020 20Percent Zinc Oxide Non Tinted ZINC OXIDE JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION 36c108f6-a928-0a54-e063-6394a90ae686 2025-12-16 Exact identifier application number: M020 20Percent Zinc Oxide Non Tinted ZINC OXIDE JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION 36c0ccca-c993-181e-e063-6294a90a7ae6 2025-12-16 Exact identifier application number: M020 Non Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION 36c0a55d-16d3-086a-e063-6394a90a30cf 2025-12-16 Exact identifier application number: M020 Eucerin Radiant Tone AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Beiersdorf Inc 2611e0cb-d56d-6ea1-e063-6294a90a745b 2025-12-16 Warnings Exact identifier application number: M020 Really Great Lip Shield TITANIUM DIOXIDE, ZINC OXIDE JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION 36c1341d-fbf5-56a5-e063-6294a90aa045 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE KLOE SALON LLC 36c23c07-2011-3ddb-e063-6294a90a76e9 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sun Defense TITANIUM DIOXIDE, ZINC OXIDE Helen's Haven 36c465ea-979b-9474-e063-6394a90ab3f8 2025-12-16 Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Helen's Haven 36c4a27b-96e9-4f30-e063-6294a90a5655 2025-12-16 Exact identifier application number: M020 Mineral Sunscreen Non Tinted TITANIUM DIOXIDE, ZINC OXIDE SAN JOSE MEDICAL SPA 37ef19e5-1775-a8d5-e063-6394a90acaef 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE, TITANIUM DIOXIDE BABYFACE LLC 36d69eb5-59b4-14a0-e063-6394a90a0a49 2025-12-16 Exact identifier application number: M020 Non Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE BABYFACE LLC 36d6141c-6967-d779-e063-6294a90af0a7 2025-12-16 Exact identifier application number: M020 Replenishing Daily Sunscreen ZINC OXIDE BABYFACE LLC 36d773d7-349d-68c1-e063-6394a90aff1e 2025-12-16 Exact identifier application number: M020 TiZO Tinted Moisturizing Serum - Light ZINC OXIDE Fallien Cosmeceuticals, Ltd. 2d44158a-44b3-5a3d-e063-6294a90a1f16 2025-12-16 Warnings Exact identifier application number: M020 TiZO Tinted Moisturizing Serum - Light-Medium ZINC OXIDE Fallien Cosmeceuticals, Ltd. 2d53071f-0275-d00c-e063-6294a90afcca 2025-12-16 Warnings Exact identifier application number: M020 TiZO Tinted Moisturizing Serum - Medium ZINC OXIDE Fallien Cosmeceuticals, Ltd. 2d550967-25af-3e7a-e063-6394a90a2c79 2025-12-16 Warnings Exact identifier application number: M020 TiZO Tinted Moisturizing Serum - Medium-Deep ZINC OXIDE Fallien Cosmeceuticals, Ltd. 2d57790c-22cf-08aa-e063-6394a90aeac0 2025-12-16 Warnings Exact identifier application number: M020 TiZO Tinted Moisturizing Serum - Deep ZINC OXIDE Fallien Cosmeceuticals, Ltd. 2d5813e8-a219-db90-e063-6294a90a6ca7 2025-12-16 Warnings Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETIC ACADEMY LLC 36c043e0-fd6c-5f7a-e063-6294a90a8899 2025-12-16 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 61477-204-26 61477020426 177 mL in 1 BOTTLE, SPRAY (61477-204-26) 177 ml 2014-02-24 0000-00-00 No No Current