Home NDC 80641-006 Vacation SPF 50 Classic
Product NDC 80641-006
11-digit product format 806410006
Labeler code 80641
Product ID 80641-006_b319ee65-f0d1-40a8-b1d9-ceb3885d86ee
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form LOTION
Route TOPICAL
Labeler Vacation INC.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-11-01
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 2.8; 9.8; 4.9; 9.5 g/100mL; g/100mL; g/100mL; g/100mL
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 Vacation SPF 50 Classic
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 2.8 g/100mL HOMOSALATE 9.8 g/100mL OCTISALATE 4.9 g/100mL OCTOCRYLENE 9.5 g/100mL
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 80641-006-01 Vacation SPF 50 Classic 100 mL in 1 TUBE LOTION 100 5 80641-006-04 Vacation SPF 50 Classic 177 mL in 1 TUBE LOTION 177 5 80641-006-08 Vacation SPF 50 Classic 1 in 1 BLISTER PACK LOTION 1 5 80641-006-18 Vacation SPF 50 Classic 591 mL in 1 BOTTLE, PUMP LOTION 591 5 80641-006-80 Vacation SPF 50 Classic 30 mL in 1 TUBE LOTION 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80641-006 VACATION SPF 50 CLASSIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [VACATION INC.] 4 Current NDC, 5 package rows 20250223_f268fb1c-d7c2-f2f9-e053-2995a90a9e22.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 296 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Giorgio Armani Power Fabric Plus Weightless Matte Foundation Broad Spectrum SPF 25 Sunscreen OCTINOXATE SICOS ET CIE 3b49a970-653b-4256-b2d3-4e065db63849 2024-06-24 Warnings Exact identifier application number: M020 Giorgio Armani Power Fabric Plus Weightless Matte Foundation Broad Spectrum SPF 25 Sunscreen OCTINOXATE L'Oreal USA Products Inc. 1b851e19-add0-437b-86e4-e88a10a1e774 2024-06-24 Warnings Exact identifier application number: M020 Exel Clarifying Line SPF 50 OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE Biocosmetica Exel Argentina SRL e65a68f6-d1b7-4cbf-a3f8-5cc04036221a 2024-06-23 Warnings Exact identifier application number: M020 Bitchstix Citrus Orange Broad Spectrum SPF 30 Sunscreen Lip Balm SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Bitchstix, LLC 1b6bf419-554c-86a7-e063-6294a90a5a7e 2024-06-21 Warnings Exact identifier application number: M020 OS-01 Body SPF 30 ZINC OXIDE Allure Labs 1b582f4e-553f-a511-e063-6294a90af3c0 2024-06-20 Warnings Exact identifier application number: M020 Seaweed Bath Co Playful Papaya Kids Sunscreen SPF 50 ZINC OXIDE The Seaweed Bath Co. 65c9c131-2545-4d88-aa9a-85197b654d74 2024-06-19 Warnings Exact identifier application number: M020 Protectif Fair Tint ZINC OXIDE AND TITANIUM DIOXIDE Derma Research Group Inc. 1a8c8804-1d6b-b5a5-e063-6394a90a1260 2024-06-18 Warnings Exact identifier application number: M020 EB-5 Super Hydrating Anti-Aging SPF-50 OCTOCRYLENE, ZINC OXIDE, OCTISALATE LIFE O, INC. b9521112-d119-4d48-8504-4e46b434f76f 2024-06-17 Warnings Exact identifier application number: M020 Burts Bees SPF 30 Untinted Lip Balm Beaches and Cream BURTS BEES SPF 30 UNTINTED LIP BALM BEACHES AND CREAM Autumn Harp 1ac89261-eeae-567c-e063-6294a90ad45f 2024-06-13 Warnings Exact identifier application number: M020 Protectif Untinted ZINC OXIDE AND TITANIUM DIOXIDE Derma Research Group Inc. 1acd3f09-87f2-75e4-e063-6394a90a0cd9 2024-06-13 Warnings Exact identifier application number: M020 Mara Clear Skin Mineral Milk Acne Treatment SALICYLIC ACID Mara Beauty LLC 3823024e-81b4-4e29-af76-82231e09407c 2024-06-13 Warnings Exact identifier application number: M020 BOB KIDS SPF 30 Zinc only ZINC OXIDE SPF Ventures, LLC 1aae0291-f16f-7840-e063-6394a90a3443 2024-06-12 Warnings Exact identifier application number: M020 Glossier Invisible Shield SPF 50 GLOSSIER INVISIBLE SHIELD SPF 50 Autumn Harp 1ab39eae-06e9-0e4c-e063-6394a90ad8aa 2024-06-12 Warnings Exact identifier application number: M020 Thinksport SPF 50 ZINC OXIDE thinkOperations,LLC 2e83e382-8eb0-40f2-bdca-2db5e184661e 2024-06-10 Warnings Exact identifier application number: M020 Thinkkids SPF 50 ZINC OXIDE thinkOperations,LLC 09f9d9bb-c08b-401c-bbf1-640f1c8ec678 2024-06-07 Warnings Exact identifier application number: M020 NAELI Day Moisturizer Broad Spectrum SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE ALLI LLC f2cebdc7-c96e-46cf-9b5c-b4965ddd2aec 2024-06-06 Warnings Exact identifier application number: M020 Youth 3 Activating BB Cream SPF 30 Medium ZINC OXIDE, TITANIUM DIOXIDE Shaklee Corporation ccc80ea4-f270-4fd4-970c-eaa63df936e4 2024-06-06 Warnings Exact identifier application number: M020 Thinkbaby SPF 50 ZINC OXIDE thinkOperations,LLC f2788a1a-daf6-4b7d-8333-585a380ebe57 2024-06-05 Warnings Exact identifier application number: M020 RMS SUNCOVERUP SUPER TINT SPF 50 ALABASTER ZINC OXIDE Rms organics LLC 1a11c884-d6ba-d77f-e063-6394a90a5bd2 2024-06-04 Warnings Exact identifier application number: M020 toty Solaria Body OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE CHIPICAN LLC 1a121b17-3621-6bc1-e063-6394a90ac9a1 2024-06-04 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 80641-006-01 80641000601 100 mL in 1 TUBE (80641-006-01) 100 ml 2022-11-01 No No Current 80641-006-04 80641000604 177 mL in 1 TUBE (80641-006-04) 177 ml 2026-03-09 No No Current 80641-006-08 80641000608 1 TUBE in 1 BLISTER PACK (80641-006-08) / 177 mL in 1 TUBE (80641-006-04) 1 tube 2026-03-09 No No Current 80641-006-18 80641000618 591 mL in 1 BOTTLE, PUMP (80641-006-18) 591 ml 2024-03-01 No No Current 80641-006-80 80641000680 30 mL in 1 TUBE (80641-006-80) 30 ml 2022-11-01 No No Current