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 91 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bellas Friends Sunscreen Stick ZINC OXIDE Panergytek Usa Inc 478cbdeb-28e4-fa56-e063-6294a90af124 2026-01-04 Warnings Exact identifier application number: M020 Bellas Friends Roll-on Sunscreen TITANIUM DIOXIDE, ZINC OXIDE PANERGYTEK USA INC 478d46ce-14e8-2231-e063-6394a90a3e27 2026-01-04 Warnings Exact identifier application number: M020 Ava Isa Sun Lip Sun Whip Clear Sunshine ZINC OXIDE Cyberderm Laboratories inc. a8646ee4-5e6e-6cdd-e053-2a95a90aee77 2026-01-01 Warnings Exact identifier application number: M020 Ava Isa Sun Lip Sun Whip Strawberry Zinnia ZINC OXIDE Cyberderm Laboratories inc. a888396f-489f-7e7c-e053-2995a90aee5b 2026-01-01 Warnings Exact identifier application number: M020 Ava Isa Sun Lip Sun Whip Watermelon Lily ZINC OXIDE Cyberderm Laboratories inc. a8889754-8e33-4d2a-e053-2995a90a6080 2026-01-01 Warnings Exact identifier application number: M020 OKeeffes Lip Repair AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTOCRYLENE The Gorilla Glue Company/O'Keeffe's Company 6805b3e9-77cb-bfee-e053-2991aa0a8d98 2026-01-01 Warnings Exact identifier application number: M020 Walgreens 50 Pina Colada Scented Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WALGREEN COMPANY 4978c811-be34-9fc3-e063-6394a90a2d80 2026-01-01 Warnings Exact identifier application number: M020 Unicorn Snot 35 SPF Glitter Spritz rose gold shimmer AVOBENZONE, OCTISALATE, OCTOCRYLENE Jailbreak Toys, Inc. DBA UNICORN SNOT 498b7c1a-e66d-9736-e063-6394a90a4712 2026-01-01 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Day Cream SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE BCM Ltd f7d5aa8a-9f4a-426b-ac9d-9690cf0103e0 2026-01-01 Warnings Exact identifier application number: M020 MAUI ISLAND SECRET BROWNING CREME Broad Spectrum Sunscreen SPF 5 ZINC OXIDE Formula 7venz L.L.C. 5f3cdec9-2cc2-4660-827f-d286883d907c 2025-12-31 Warnings Exact identifier application number: M020 SOLARA SUNCARE - GO VACATION GLOW SPF 30 ZINC OXIDE SOLARA SUNCARE, INC. 1f5cb694-f065-7ebc-e063-6394a90a883a 2025-12-31 Warnings Exact identifier application number: M020 SUNSCREEN GLOWING, SPF 30 SUNSCREEN GLOWING LOTION FSA Store Inc 473bcb90-ab7f-170b-e063-6294a90a99d5 2025-12-31 Warnings Exact identifier application number: M020 HAWAIIAN TROPIC AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 05ba5966-f0ff-5360-e063-6294a90a0fc9 2025-12-31 Warnings Exact identifier application number: M020 HAWAIIAN TROPIC AVOBENZONE,HOMOSALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 08f4599b-de62-2bc7-e063-6394a90a69ab 2025-12-31 Warnings Exact identifier application number: M020 Hawaiian Tropic Everyday Active SPF50 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC dc8e2ee8-e67f-ef5d-e053-2995a90a1520 2025-12-31 Warnings Exact identifier application number: M020 Sunscreen Glowing, SPF 30 SUNSCREEN GLOWING LOTION Cardinal Health, Inc 28ed3b60-1139-f657-e063-6394a90a52fa 2025-12-31 Warnings Exact identifier application number: M020 Sunscreen Setting Spritz, SPF 45 SUNSCREEN SETTING SPRAY Cardinal Health, inc. 293e9656-8644-b9aa-e063-6294a90a5b27 2025-12-31 Warnings Exact identifier application number: M020 Sunscreen Setting Spritz, SPF 45 SUNSCREEN SETTING SPRAY FSA Store Inc 473d6804-8d20-6899-e063-6294a90a3131 2025-12-31 Warnings Exact identifier application number: M020 Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - Fair OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 47428cd4-fbad-ba7a-e063-6394a90a1c5c 2025-12-31 Warnings Exact identifier application number: M020 Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - Medium OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 47433a62-91e0-b031-e063-6294a90a0d49 2025-12-31 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 61477-204-26 61477020426 177 mL in 1 BOTTLE, SPRAY (61477-204-26) 177 ml 2014-02-24 0000-00-00 No No Current