Home NDC 63049-102-25 EAD
Product NDC 63049-102
Requested package NDC 63049-102-25
11-digit product format 630490102
Labeler code 63049
Product ID 63049-102_0deaeb50-176d-4b16-b4a0-c2f9fcec093a
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
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; OXYBENZONE
Active strength 2 g/120mL; 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, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 AVOBENZONE ACTIVE MOIETY G63QQF2NOX EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 HOMOSALATE ACTIVE MOIETY V06SV4M95S EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 OCTISALATE ACTIVE MOIETY 4X49Y0596W EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 .ALPHA.-AMYLCINNAMALDEHYDE INACTIVE INGREDIENT WC51CA3418 EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 ALPHA-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 ASCORBYL PALMITATE INACTIVE INGREDIENT QN83US2B0N EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 C12-15 ALKYL BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 CARBOMER 934 INACTIVE INGREDIENT Z135WT9208 EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 EDETATE SODIUM INACTIVE INGREDIENT MP1J8420LU EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 ETHYLPARABEN INACTIVE INGREDIENT 14255EXE39 EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 GLYCERYL STEARATE SE INACTIVE INGREDIENT FCZ5MH785I EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 ISOBUTYLPARABEN INACTIVE INGREDIENT 0QQJ25X58G EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 LINALOOL, (+/-)- INACTIVE INGREDIENT D81QY6I88E EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 POLYOXYL 20 CETOSTEARYL ETHER INACTIVE INGREDIENT YRC528SWUY EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 SODIUM CETOSTEARYL SULFATE INACTIVE INGREDIENT 7ZBS06BH4B EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C] 5 WATER INACTIVE INGREDIENT 059QF0KO0R EAD (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) 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 63049-102-25 63049010225 95 mL in 1 TUBE (63049-102-25) 95 ml 2015-11-12 0000-00-00 No No Current