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 24 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lancome Paris Teint Idole Ultra Wear Care and Glow Skincare Foundation Broad Spectrum SPF 27 Sunscreen ENSULIZOLE L'Oreal USA Products Inc 79fd34ad-cd4a-4fa0-9b7c-e0a2252654da 2026-05-27 Warnings Exact identifier application number: M020 Lancome Paris Teint Idole Ultra Wear Care and Glow Skincare Foundation Broad Spectrum SPF 27 Sunscreen ENSULIZOLE SICOS ET CIE 3ff286c0-4515-4cab-9b93-a782545b2f36 2026-05-27 Warnings Exact identifier application number: M020 MyDerm SPF 50 HOMOSALATE 10.00% OCTOCRYLENE 6.00% AVOBENZONE 3.00% Inspec Solutions LLC 1a995cda-dc67-419c-90e6-c61050c76098 2026-05-27 Warnings Exact identifier application number: M020 Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkle AVOBENZONE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 2b634b3f-0d2b-4ae4-b302-9befb14a90df 2026-05-27 Warnings Exact identifier application number: M020 Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkle AVOBENZONE, OCTISALATE AND OCTOCRYLENE SICOS ET CIE fce593a2-f4ed-46c1-81a1-be3941649e47 2026-05-27 Warnings Exact identifier application number: M020 BROTEGE Good Boy Protection SPF 15 and Retinol Daily Moisturizer BENZOPHENONE-3, BUTYLE METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE Spa de Soleil 1f47e508-58dd-fab4-e063-6394a90a668a 2026-05-27 Warnings Exact identifier application number: M020 GOONGBE Waterful SunLotion Mild SPF 40 ZINC OXIDE Zero to Seven Inc. 1e86edfd-d089-ba41-e063-6294a90a6709 2026-05-27 Warnings Exact identifier application number: M020 GOONGBE Baby Easy Wash SunLotion SPF 30 ZINC OXIDE Zero to Seven Inc. 1e86c2a9-a5c3-95cb-e063-6394a90a014d 2026-05-27 Warnings Exact identifier application number: M020 Stream2Sea Reef Safer Mineral Sunscreen SPF40 ZINC OXIDE Stream2Sea, LLC 52e73c23-75ec-d8a8-e063-6294a90a5493 2026-05-27 Warnings Exact identifier application number: M020 Riversol Tinted Lip Oil - Rosewood ZINC OXIDE Riversol 52b8f588-8383-634e-e063-6294a90a8f8b 2026-05-26 Warnings Exact identifier application number: M020 Riversol Tinted Lip Oil - Poppy ZINC OXIDE Riversol 52b92725-6d9a-768a-e063-6394a90ac933 2026-05-26 Warnings Exact identifier application number: M020 Odacite Nourishing Lip Serum - Jazzy Berry ZINC OXIDE Odacite 52b97fb0-84d6-a408-e063-6294a90a9be9 2026-05-26 Warnings Exact identifier application number: M020 Odacite Nourishing Lip Serum - True Nude ZINC OXIDE Odacite 52b9be2a-4958-f537-e063-6294a90a7a1b 2026-05-26 Warnings Exact identifier application number: M020 Riversol Tinted Lip Oil - Poppy ZINC OXIDE Solesence, Inc. 52ba09cb-edcc-a405-e063-6394a90a6aab 2026-05-26 Warnings Exact identifier application number: M020 Odacite Nourishing Lip Serum - Bubble Gum ZINC OXIDE Odacite 52b9fb0a-0554-0de2-e063-6294a90a09d3 2026-05-26 Warnings Exact identifier application number: M020 Riversol Tinted Lip Oil - Rosewood ZINC OXIDE Solesence, Inc. 52ba07f1-b74e-a4b6-e063-6394a90a7473 2026-05-26 Warnings Exact identifier application number: M020 Broad Spectrum SPF 50 Sunscreen ZINC OXIDE SKIN DAMAGE INC. 52ba2f12-839f-cea1-e063-6394a90a5ae6 2026-05-26 Warnings Exact identifier application number: M020 Odacite Color Balm - Bronze Jolie ZINC OXIDE Odacite 52ba360e-375c-0469-e063-6294a90a020e 2026-05-26 Warnings Exact identifier application number: M020 Odacite Color Balm - Golden Hour ZINC OXIDE Odacite 52ba8e03-1944-b73d-e063-6294a90a5039 2026-05-26 Warnings Exact identifier application number: M020 Odacite Color Balm - Sienna Rose ZINC OXIDE Odacite 52ba7f12-2b79-79cf-e063-6294a90a92d8 2026-05-26 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