Home NDC 80641-013 Drops
Product NDC 80641-013
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 13 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VERSED MULTI SERUM SKIN TINT SPF 40 DEEP WRM ZINC OXIDE COSMAX USA, CORP 5647ae2c-bcba-63c0-e063-6394a90ad5bc 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 TAN DEEP WRM ZINC OXIDE COSMAX USA, CORP 56478f3d-f25c-bef7-e063-6294a90ade09 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 TAN DEEP COOL ZINC OXIDE COSMAX USA, CORP 564796f8-072f-61f2-e063-6394a90ab394 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 DEEP COOL ZINC OXIDE COSMAX USA, CORP 5647e63c-a695-1b40-e063-6394a90a5767 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 DEEP NEUTRAL ZINC OXIDE COSMAX USA, CORP 5647d0f1-945f-b0b7-e063-6294a90aafe2 2026-07-10 Warnings Exact identifier application number: M020 LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 Sunset Sands ZINC OXIDE COSMAX USA, CORP 5648da76-5a67-605a-e063-6294a90a4e3b 2026-07-10 Warnings Exact identifier application number: M020 Coco and Eve Tan Boosting Anti Aging Body Oil SPF 45 HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE COSMAX USA, CORP 5648d637-9743-97a7-e063-6294a90ad8a1 2026-07-10 Warnings Exact identifier application number: M020 The Mineral Lip One SPF 45 Nourishing Lip Tint Vanilla Cloud ZINC OXIDE COSMAX USA, CORP 5648c90b-b814-c16e-e063-6394a90a3e1f 2026-07-10 Warnings Exact identifier application number: M020 The Mineral Lip One SPF 45 Nourishing Lip Tint Berry Balmy ZINC OXIDE COSMAX USA, CORP 56490982-200d-e3a7-e063-6394a90a72a4 2026-07-10 Warnings Exact identifier application number: M020 PRIME Prometics LipOil SPF 35 Warm Sienna ZINC OXIDE COSMAX USA, CORP 56491794-712d-1306-e063-6394a90a4707 2026-07-10 Warnings Exact identifier application number: M020 PRIME Prometics LipOil SPF 35 Bright Berry ZINC OXIDE COSMAX USA, CORP 56491833-5053-c85e-e063-6294a90ac4f5 2026-07-10 Warnings Exact identifier application number: M020 PRIME Prometics LipOil SPF 35 Nude Rose ZINC OXIDE COSMAX USA, CORP 56493964-1d5b-2fc7-e063-6394a90a7492 2026-07-10 Warnings Exact identifier application number: M020 PRIME Prometics LipOil SPF 35 Soft Petal ZINC OXIDE COSMAX USA, CORP 5649df7b-9d2c-d8eb-e063-6394a90acf99 2026-07-10 Warnings Exact identifier application number: M020 PRIME Prometics LipOil SPF 35 Nude Glow ZINC OXIDE COSMAX USA, CORP 564a6566-442c-b933-e063-6294a90a6f9b 2026-07-10 Warnings Exact identifier application number: M020 SOFIE PAVITT FACE SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE COSMAX USA., CORP 564ae5d2-1504-9623-e063-6394a90a2fa5 2026-07-10 Warnings Exact identifier application number: M020 IDEALOVE HYDROGLOW DAILY SUNSCREEN SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE COSMAX USA, CORP 564b284c-3248-c6c0-e063-6394a90a1103 2026-07-10 Warnings Exact identifier application number: M020 SOFIE PAVITT FACE SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE COSMAX USA., CORP 564b1ed2-aa98-a334-e063-6294a90a169b 2026-07-10 Warnings Exact identifier application number: M020 LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 GOLDEN HOUR ZINC OXIDE COSMAX USA, CORP 564b559e-6fe8-e98e-e063-6294a90a8f0e 2026-07-10 Warnings Exact identifier application number: M020 LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 BLISS ON THE BEACH ZINC OXIDE COSMAX USA, CORP 564b63f2-701e-f5bd-e063-6394a90af797 2026-07-10 Warnings Exact identifier application number: M020 LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 GOING COCONUTS ZINC OXIDE COSMAX USA, CORP 564b5ab3-0a7c-f663-e063-6394a90a0c3d 2026-07-10 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 80641-013-01 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 80641-013-80 80641001380 30 mL in 1 BOTTLE, DROPPER (80641-013-80) 30 ml 2024-03-07 No No Current 80641-013-94 80641001394 30 mL in 1 BOTTLE, DROPPER 30 ml Historical