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 215 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Broad Spectrum SPF45 ZINC OXIDE, OCTINOXATE Drmtlgy, LLC ce93b371-26ab-4493-98e0-98234c3a9ba6 2025-05-01 Warnings Exact identifier application number: M020 Winter Rescue Kit OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE DUKE CANNON SUPPLY CO. 24356548-348d-2cd2-e063-6294a90ab352 2025-04-29 Warnings Exact identifier application number: M020 Prequel Lip Visor SPF 30 CLEAR LIP 30 CLEAR The Center Brands, LLC 33d5d1d4-c516-238c-e063-6294a90ac11c 2025-04-28 Warnings Exact identifier application number: M020 LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE BEL STAR SA 33db89ac-2653-78f5-e063-6394a90af03d 2025-04-28 Warnings Exact identifier application number: M020 Lifeguard SUNSCREEN SPHERE 8 INC 32be4eb3-f106-182d-e063-6394a90aa484 2025-04-28 Warnings Exact identifier application number: M020 Practical Alchemy Purify and Protect Duo MICELLAR WATER WIPES AND ZINC OXIDE Over Here, LLC 28514e58-59a6-094a-e063-6394a90a1c7d 2025-04-28 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Porcelain OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 2fbf7f9d-dba7-48f9-b10e-63225e8f1399 2025-04-25 Warnings Exact identifier application number: M020 BEEF TALLOW SUNSCREEN ZINC OXIDE Yunqi Cosmetics (Shenzhen) Co., Ltd 3380a271-1538-2e3a-e063-6294a90a90a2 2025-04-24 Warnings Exact identifier application number: M020 BEEF TALLOW SUNSCREEN ZINC OXIDE Yunqi Cosmetics (Shenzhen) Co., Ltd 3380f1ac-0320-35f2-e063-6394a90a97eb 2025-04-24 Warnings Exact identifier application number: M020 BEEF TALLOW SUNSCREEN ZINC OXIDE 15% Yunqi Cosmetics (Shenzhen) Co., Ltd 33813fe1-8496-d541-e063-6294a90a6254 2025-04-24 Warnings Exact identifier application number: M020 Sunstation Sport Sunscreen SPF 30 OCTISALATE, OCTOCRYLENE, ZINC OXIDE Impact Melanoma Inc ba78aa73-a25b-4a8e-99b2-9262bb9a7d27 2025-04-24 Warnings Exact identifier application number: M020 Olay Age Defying Anti-Wrinkle Day Broad Spectrum SPF 15 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE The Procter & Gamble Manufacturing Company 42819c8d-cc0a-4bee-95db-39a69ce7f660 2025-04-24 Warnings Exact identifier application number: M020 LBEL FOREVER MATTE LONGWEAR AND CONTROL FOUNDATION 72H SPF 15 CHAMPAGNE 170N OCTINOXATE, ZINC OXIDE BEL STAR S.A. 338c2c66-497a-f7d1-e063-6294a90a7789 2025-04-24 Warnings Exact identifier application number: M020 The Ordinary UV Filters SPF 45 Serum HOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE Deciem 10cde253-26ee-b97d-e063-6394a90a8302 2025-04-23 Warnings Exact identifier application number: M020 BareBack sunscreen SPF50 infused with Hyaluronic acid and vitamin C ZINC OXIDE VeganicSKN 3123aab6-0407-19e5-e063-6394a90a5bd8 2025-04-23 Warnings Exact identifier application number: M020 Sephora Daily Sunscreen Cream Broad Spectrum SPF 30 ZINC OXIDE S+ b49e043b-8164-421c-a02b-3dab0be1454d 2025-04-22 Warnings Exact identifier application number: M020 YAYA Organics SPF-50 Sports Cream ZINC OXIDE YAYA ORGANICS L.L.C. 9eabf1f8-698b-4fa8-98d3-3696c35b044c 2025-04-22 Warnings Exact identifier application number: M020 YAYA Organics SPF-50 Baby Kids Mineral Sunscreen ZINC OXIDE YAYA ORGANICS L.L.C. 3275303d-a448-4fb4-bdce-6442823f8996 2025-04-22 Warnings Exact identifier application number: M020 Oathology Inzincable Sunscreen SPF 50 HOMOSALATE, OCTOCRYLENE, ZINC OXIDE SKINOATH LLC d245dfca-9e32-4e71-9df8-58fff84ef6a9 2025-04-22 Warnings Exact identifier application number: M020 Back9ine Skincare Pure Invisible Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Back 9ine Skincare, LLC 974ede40-cfb5-4612-b168-5d42dd137f63 2025-04-22 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