EAD Kids

Product NDC
63049-105
Requested package NDC
63049-105-24
11-digit product format
630490105
Labeler code
63049
Product ID
63049-105_e259f9c5-6558-46aa-941f-23d7f0556c57
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octocrylene, Octisalate, Oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
EUROPEAN PERFUME WORKS CO. LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-12-21
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE; OXYBENZONE
Active strength
3 g/88mL; g/88mL; g/88mL; g/88mL; g/88mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63049-10563049-105-24DDiscontinued by firm2026-10-15

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
HOMOSALATEACTIVE MOIETYV06SV4M95SEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
OCTISALATEACTIVE MOIETY4X49Y0596WEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0EAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8EAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208EAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39EAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4EAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785IEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58GEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88EEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999READ KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
PEG-60 ALMOND GLYCERIDESINACTIVE INGREDIENT4Y0E651N0FEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
ROSA MOSCHATA SEED OILINACTIVE INGREDIENTT031ZE559TEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
SODIUM CETOSTEARYL SULFATEINACTIVE INGREDIENT7ZBS06BH4BEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IEAD KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1
WATERINACTIVE INGREDIENT059QF0KO0READ KIDS (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [EUROPEAN PERFUME WORKS CO.L.L.C]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63049-105-246304901052488 mL in 1 TUBE (63049-105-24) 88 ml2014-12-210000-00-00NoNoCurrent