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 299 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MELAN SPF-30 Antioxidant Body Mist Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE MELAN INC. 66b7c899-46fd-41a6-9a96-ebbf2b68ea25 2024-05-02 Warnings Exact identifier application number: M020 No7 Restore and Renew Face and Neck Multi Action Day Cream Sunscreen Broad Spectrum SPF 30 AVOBENZONE,OCTISALATE, OCTOCRYLENE. BCM Ltd 4ce3fe14-e33d-cbf6-e063-6294a90a42fe 2024-04-30 Warnings Exact identifier application number: M020 bareMinerals BAREPRO 24HR Wear Skin-Perfecting Matte Liquid Foundation Fair 10 Neutral ZINC OXIDE Orveon Global US LLC 1740393b-f8a3-475b-e063-6394a90a6fa8 2024-04-29 Warnings Exact identifier application number: M020 SUMMER GELEE SPF-30 HOMOSALATE, OCTISALATE, OCTOCRYLENE SUMMER GELEE LLC bc85db65-2acc-4b39-9189-f8916c487b61 2024-04-27 Warnings Exact identifier application number: M020 SUMMER GELEE SPF-4 HOMOSALATE, OCTISALATE SUMMER GELEE LLC c9ec81ad-0478-4026-bc6c-5582eb012b8d 2024-04-27 Warnings Exact identifier application number: M020 Natural Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Sarati International, Inc. 16ef922d-78d1-1e70-e063-6394a90a3bbf 2024-04-25 Warnings Exact identifier application number: M020 PRISMA PROTECT SPF30 OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONE Dermalogica, LLC. e0e6d779-c491-43ed-acc9-274d1b60c1ff 2024-04-25 Warnings Exact identifier application number: M020 Degil Sun SPF 30 Sunscreen HOMOSALATE, OCTISALATE, OXYBENZONE,AVOBENZONE, OCTOCRYLENE Degil Safety Products (1989) Inc 16d8d1d0-e531-2a64-e063-6394a90a5b9c 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Alabaster TITANIUM DIOXIDE Chantecaille Beaute Inc e1c562b8-76c0-4c6e-9276-900784c8639e 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Wheat TITANIUM DIOXIDE Chantecaille Beaute Inc 89f19f7a-60e3-4080-a49a-a4eb3e6c27de 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Aura TITANIUM DIOXIDE Chantecaille Beaute Inc de441a6c-55e3-4b11-afb3-d7db3c6971f0 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Bliss TITANIUM DIOXIDE Chantecaille Beaute Inc 16d9e226-7694-922a-e063-6394a90aea85 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Glow TITANIUM DIOXIDE Chantecaille Beaute Inc f868fe4f-4c10-4f0f-9f1d-008f06774408 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Nude TITANIUM DIOXIDE Chantecaille Beaute Inc cb8feddc-ae98-42ea-ad1e-583dcacfa5d9 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Opaline TITANIUM DIOXIDE Chantecaille Beaute Inc 1c918b4b-763b-48bf-9ae3-661eabafee16 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Tan TITANIUM DIOXIDE Chantecaille Beaute Inc fdf05545-5a21-4238-b0d3-e3fcdfe866ff 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Topaz TITANIUM DIOXIDE Chantecaille Beaute Inc 2012f671-7889-4e29-b70f-215cbc9dbdc7 2024-04-24 Warnings Exact identifier application number: M020 Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Vanilla TITANIUM DIOXIDE Chantecaille Beaute Inc 7133c47d-ed1c-43e9-8cdf-42f7b2f215f5 2024-04-24 Warnings Exact identifier application number: M020 Eco Lips PlantPod Sunscreen Lip Balm Vanilla SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Eco Lips. Inc. fd8edc49-762a-b718-e053-6394a90a65f5 2024-04-23 Warnings Exact identifier application number: M020 SKINPERFECT PRIMER SPF30 ZINC OXIDE Dermalogica, LLC. 692f9cda-eb6c-431f-a575-3778c6e12e3b 2024-04-23 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