Home NDC 63049-101-25 EAD
Product NDC 63049-101
Requested package NDC 63049-101-25
11-digit product format 630490101
Labeler code 63049
Product ID 63049-101_f792c8a5-4fa0-42bc-ae1c-27ebd76084e3
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone,Homosalate,Octisalate,Octocrylene
Dosage form LOTION
Route TOPICAL
Labeler EUROPEAN PERFUME WORKS CO. LLC
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2014-03-18
Marketing end 0000-00-00
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 1 g/120mL; g/120mL; g/120mL; g/120mL
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 AVOBENZONE ACTIVE MOIETY G63QQF2NOX EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 HOMOSALATE ACTIVE MOIETY V06SV4M95S EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 OCTISALATE ACTIVE MOIETY 4X49Y0596W EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 .ALPHA.-AMYLCINNAMALDEHYDE INACTIVE INGREDIENT WC51CA3418 EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 ALPHA-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 ASCORBYL PALMITATE INACTIVE INGREDIENT QN83US2B0N EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 C12-15 ALKYL BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 CARBOMER 934 INACTIVE INGREDIENT Z135WT9208 EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 EDETATE SODIUM INACTIVE INGREDIENT MP1J8420LU EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 ETHYLPARABEN INACTIVE INGREDIENT 14255EXE39 EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 GLYCERYL STEARATE SE INACTIVE INGREDIENT FCZ5MH785I EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 ISOBUTYLPARABEN INACTIVE INGREDIENT 0QQJ25X58G EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 LINALOOL, (+/-)- INACTIVE INGREDIENT D81QY6I88E EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 POLYOXYL 20 CETOSTEARYL ETHER INACTIVE INGREDIENT YRC528SWUY EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 SODIUM CETOSTEARYL SULFATE INACTIVE INGREDIENT 7ZBS06BH4B EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5 WATER INACTIVE INGREDIENT 059QF0KO0R EAD (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C.] 5
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63049-101-25 63049010125 95 mL in 1 TUBE (63049-101-25) 95 ml 2015-11-12 0000-00-00 No No Current