Home NDC 80641-016 Orange Gel
Product NDC 80641-016
11-digit product format 806410016
Labeler code 80641
Product ID 80641-016_b99c06a3-7b97-4257-bd0c-8a9f3f6297de
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone Octisalate Octocrylene Homosalate
Dosage form GEL
Route TOPICAL
Labeler Vacation Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-08
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 2.9; 6.9; 4.9; 9.5 g/100g; g/100g; g/100g; g/100g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 Orange Gel
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 2.9 g/100g HOMOSALATE 6.9 g/100g OCTISALATE 4.9 g/100g OCTOCRYLENE 9.5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80641-016-02 Orange Gel 2 in 1 CARTON GEL 2 4 80641-016-30 Orange Gel 88 g in 1 TUBE GEL 88 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80641-016 ORANGE GEL (AVOBENZONE OCTISALATE OCTOCRYLENE HOMOSALATE) GEL [VACATION INC.] 3 Current NDC, 2 package rows 20250420_132896ef-d6c6-4ec7-e063-6294a90a103b.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 46 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Arizona Sun Kids Sunscreen SPF 30 SUNSCREEN Arizona Sun Products 10f60367-6681-a589-e063-6394a90a6bb8 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Sunscreen Water Resistant SPF 30 SUNSCREEN Arizona Sun Products 115b4d4c-51f1-ad62-e063-6294a90a3e53 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Sunscreen SPF 30 SUNSCREEN Arizona Sun Products 10e48195-7bae-2422-e063-6394a90a261c 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Sunscreen SPF 30 SUNSCREEN Arizona Sun Products 10e276e4-81f1-9429-e063-6394a90a800d 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Sunscreen SPF 8 SUNSCREEN Arizona Sun Products 106a9608-f7a4-0f8c-e063-6394a90a26ab 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Bikerblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fced72-39f9-f3a3-e063-6294a90a8b73 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Golfblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fc2a82-260c-7cd3-e063-6394a90af2c1 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Cycleblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fd9aa5-dbd6-e5a7-e063-6394a90a3eac 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Golfblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fc93a7-f5be-965d-e063-6394a90ab335 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Bikerblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fd1661-1b91-b65b-e063-6394a90af89b 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Lipkist Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fbcb81-2735-53c8-e063-6394a90ab0fa 2026-04-09 Warnings Exact identifier application number: M020 Arizona Sun Products Cycleblok Lip Balm SPF 15 LIP BALM Arizona Sun Products 11fd8776-99f8-e5a4-e063-6394a90a2033 2026-04-09 Warnings Exact identifier application number: M020 uLOOK Sunscreen SPF 50 SUNSCREEN HAMEX GLOBAL COSMETICS LLC 4e05588c-486b-60e0-e063-6294a90af457 2026-04-09 Warnings Exact identifier application number: M020 Pro-Tect Sports Sunscreen SPF 20 MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE ABBE Laboratories, Inc. 35869e8d-8e48-4b22-8af3-6964fe8ac182 2026-04-09 Warnings Exact identifier application number: M020 Sunright 50 AVOBENZONE, HOMOSALATE, AND OCTINOXATE NSE Products, Inc. b1b76481-da23-427f-9b34-b987019fa532 2026-04-09 Warnings Exact identifier application number: M020 ThinkBaby SPF 30 ZINC OXIDE thinkOperations,LLC 06862b00-c937-41af-ab5d-cea34160d035 2026-04-09 Warnings Exact identifier application number: M020 Nutricentials Day Dream Protective HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE NSE Products, Inc. 4a376e93-85e8-40a5-8641-d3e3d11fdeea 2026-04-08 Warnings Exact identifier application number: M020 AGE20S UV MINERAL PRIMING SUNSCREEN ZINC OXIDE Aekyung Industrial Co., Ltd. 43c1f70b-0664-40be-e063-6394a90a2b48 2026-04-08 Warnings Exact identifier application number: M020 AGE20S SUNSCREEN DUO ZINC OXIDE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Aekyung Industrial Co., Ltd. 4eef11cd-85a1-0e44-e063-6394a90a5d44 2026-04-08 Warnings Exact identifier application number: M020 Neutrogena MINERAL UV TINT FACE DEEP SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Acupac Packaging, Inc. 4ef430e8-cdc8-2897-e063-6394a90a3ac7 2026-04-08 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80641-016-02 80641001602 2 TUBE in 1 CARTON (80641-016-02) / 88 g in 1 TUBE (80641-016-30) 2 tube 2025-04-18 No No Current 80641-016-30 80641001630 88 g in 1 TUBE (80641-016-30) 88 g 2024-03-08 No No Current