Home NDC 80641-013-01 Drops
Product NDC 80641-013
Requested package NDC 80641-013-01
11-digit product format 806410013
Labeler code 80641
Product ID 80641-013_2e99f7af-047a-769c-e063-6394a90a1406
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone Octisalate Octocrylene
Dosage form LIQUID
Route TOPICAL
Labeler Vacation Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-07
Substance AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength 2.9; 4.9; 7.6 g/100mL; g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
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 Drops
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 2.9 g/100mL OCTISALATE 4.9 g/100mL OCTOCRYLENE 7.6 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G63QQF2NOX Internal UNII lookup 4X49Y0596W Internal UNII lookup 5A68WGF6WM Internal UNII lookup
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 80641-013-01 Drops 1 in 1 KIT LIQUID 1 4 80641-013-80 Drops 30 mL in 1 BOTTLE, DROPPER LIQUID 30 4 80641-013-94 Drops 30 mL in 1 BOTTLE, DROPPER LIQUID 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80641-013 DROPS (AVOBENZONE OCTISALATE OCTOCRYLENE) LIQUID [VACATION INC.] 4 Current NDC, 3 package rows 20250223_1319d6ea-a580-79c5-e063-6394a90a4dca.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 166 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join e.l.f Sun Boss Gloss SPF 25 Sunscreen Blush Much ZINC OXIDE e.l.f. Cosmetics, Inc. 53d64042-f9ef-494d-a347-490c6a3c49b8 2025-11-07 Warnings Exact identifier application number: M020 e.l.f. Suntouchable Invisi SPF 50 OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE e.l.f cosmetics,Inc. 547eac8c-492e-4a6b-ac58-4f0d1e0ccb3d 2025-11-07 Warnings Exact identifier application number: M020 e.l.f Sun Boss Gloss SPF 25 Sunscreen Thats my Jam ZINC OXIDE e.l.f. Cosmetics, Inc. b7d56015-4734-4ce4-b40d-64236df810e3 2025-11-07 Warnings Exact identifier application number: M020 elf Sun Boss Gloss SPF 25 Sunscreen Peachy Kween ZINC OXIDE e.l.f. Cosmetics, Inc. 4d9784b6-c54d-483d-a5ba-c557a05300ec 2025-11-07 Warnings Exact identifier application number: M020 ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 ON THE GLOW ZINC OXIDE In The Pynk LLC 13badac4-e310-9589-e063-6394a90ab06b 2025-11-07 Warnings Exact identifier application number: M020 ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 GOLDEN HOUR ZINC OXIDE In The Pynk LLC 13bb8426-27cd-fbc9-e063-6294a90a8bf8 2025-11-07 Warnings Exact identifier application number: M020 ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 DEW YOU ZINC OXIDE In The Pynk LLC 1365c6d8-64cb-3cb3-e063-6394a90a9d64 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 10w ZINC OXIDE e.l.f. Cosmetics, Inc c8a935e6-f7ac-4e3a-e053-2a95a90a877a 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 11w ZINC OXIDE e.l.f. Cosmetics, Inc c8a94fb4-8752-587c-e053-2995a90a1e9a 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 13w ZINC OXIDE e.l.f. Cosmetics, Inc c8a9bf6c-80cd-5884-e053-2a95a90a4a66 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 12w ZINC OXIDE e.l.f. Cosmetics, Inc c8a99278-21e0-c517-e053-2a95a90ade37 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 1C ZINC OXIDE e.l.f. Cosmetics, Inc c8a82c8b-e308-15e9-e053-2995a90afa2a 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 14w ZINC OXIDE e.l.f. Cosmetics, Inc c8aa4629-1573-48a7-e053-2995a90aa86c 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 2w ZINC OXIDE e.l.f. Cosmetics, Inc. c8a82f54-839d-1de0-e053-2a95a90a2a97 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 4W ZINC OXIDE e.l.f. Cosmetics, Inc c8a83921-3181-396e-e053-2a95a90a02ee 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 3N ZINC OXIDE e.l.f. Cosmetics, Inc c8aa6047-ce3e-59f7-e053-2a95a90a678e 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 5N ZINC OXIDE e.l.f. Cosmetics, Inc c8aa6047-ce42-59f7-e053-2a95a90a678e 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 6w ZINC OXIDE e.l.f. Cosmetics, Inc c8a8ef6f-4426-a981-e053-2a95a90a9451 2025-11-07 Warnings Exact identifier application number: M020 Well People Lip Butter SPF 15 Sunscreen PEACH ZINC OXIDE e.l.f. Cosmetics, Inc c8aa931b-a3b4-6804-e053-2995a90a3eab 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 7N ZINC OXIDE e.l.f. Cosmetics, Inc c8aa6047-ce45-59f7-e053-2a95a90a678e 2025-11-07 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 80641-013-01 80641001301 1 BOTTLE, DROPPER in 1 KIT (80641-013-01) / 30 mL in 1 BOTTLE, DROPPER (80641-013-94) 2024-03-07 No No Current