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 297 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RMS SUNCOVERUP SUPER TINT SPF 50 MAHOGANY ZINC OXIDE Rms organics LLC 1a1aebea-ed0c-ac92-e063-6294a90aeae6 2024-06-04 Warnings Exact identifier application number: M020 Brush On Block SPF 30 Mineral Powder Translucent Zinc Only ZINC OXIDE SPF Ventures, LLC 1a1bf910-f1bc-bd75-e063-6294a90a663f 2024-06-04 Warnings Exact identifier application number: M020 PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreen TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD 0b62062d-b77e-4e6c-b3ab-b35ab24db7cb 2024-06-04 Warnings Exact identifier application number: M020 Protectif Deep Tint ZINC OXIDE AND TITANIUM DIOXIDE Derma Research Group Inc. 19b19023-1340-6609-e063-6394a90a6eaf 2024-05-30 Warnings Exact identifier application number: M020 EltaMD UV Sport SPF50 ZINC OXIDE, OCTINOXATE AND OCTISALATE SUNSCREEN CP Skin Health Group, Inc. dffc3fde-5b6e-4a62-8289-9733be43455b 2024-05-30 Warnings Exact identifier application number: M020 Vacation by Vacation Scent and Shimmer Duo AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Vacation Inc. aef8388f-84bb-4e2b-8ae2-aa64f415a632 2024-05-28 Warnings Exact identifier application number: M020 SPF50 Sunscreen Cariposa ZINC OXIDE Talent Brands Company LLC 1938fa13-875a-140e-e063-6294a90a5514 2024-05-24 Warnings Exact identifier application number: M020 Derma E Vitamin C Weightless Moisturizer SPF 45 ZINC OXIDE derma e a3b404a6-e4b1-4c08-a8ef-77446dd2e411 2024-05-24 Warnings Exact identifier application number: M020 COOLA Classic Liplux Lip Balm SPF 30 Original AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC eeb420f0-c92f-0d96-e053-2a95a90afe36 2024-05-22 Warnings Exact identifier application number: M020 COOLA Mineral Liplux Lip Balm SPF 30 Nude Beach TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC ee2842c3-65e0-3904-e053-2a95a90aabff 2024-05-22 Warnings Exact identifier application number: M020 COOLA Mineral Liplux Lip Balm SPF 30 Firecracker TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC ee026a1c-885b-256f-e053-2a95a90af564 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic SPF 50 Mineral Sunscreen Vanilla Coco TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC ec96dee8-85e8-3147-e053-2995a90aaf53 2024-05-22 Warnings Exact identifier application number: M020 COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Bronze Goddess TITANIUM DIOXIDE COOLA, LLC eeb406c6-a543-379a-e053-2995a90a4998 2024-05-22 Warnings Exact identifier application number: M020 COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Fresh Rose TITANIUM DIOXIDE COOLA, LLC ee01642f-478e-b307-e053-2a95a90a7d81 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic SPF 30 Mineral Sunscreen Coco Mango ZINC OXIDE COOLA, LLC eca9ae89-19dc-516d-e053-2995a90a4698 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic Mineral Matte Untinted Face SPF 30 TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC ecabcc89-fb09-41a9-e053-2995a90a8b31 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic Mineral Matte Tinted Face SPF 30 TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC ee018c21-dca7-28aa-e053-2a95a90a3bdb 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic SPF 30 Mineral Sunscreen Citrus Cooler ZINC OXIDE COOLA, LLC ecaad342-1873-60bc-e053-2995a90a5952 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic Mineral Shimmer SPF 30 Golden Daze TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC eeb70034-0f8d-a46d-e053-2a95a90a8130 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic Mineral Shimmer SPF 30 Diamond Dust TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC eec83ecb-d0ab-7857-e053-2995a90a40ed 2024-05-22 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