Home NDC 0187-5500-04 Purpose
Product NDC 0187-5500
Requested package NDC 0187-5500-04
11-digit product format 001875500
Labeler code 0187
Product ID 0187-5500_25ecf41f-85d3-4f2b-9e4d-8ec40d6474d1
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, Octisalate and Oxybenzone
Dosage form LOTION
Route TOPICAL
Labeler Bausch Health US LLC
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2013-10-07
Marketing end 0000-00-00
Substance OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength 76 mg/mL; mg/mL; mg/mL
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0187-5500 0187-5500-04 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0187-5500 0187-5500-04 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 Octinoxate ACTIVE INGREDIENT 4Y5P7MUD51 PURPOSE (OCTINOXATE, OCTISALATE AND OXYBENZONE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Octisalate ACTIVE INGREDIENT 4X49Y0596W PURPOSE (OCTINOXATE, OCTISALATE AND OXYBENZONE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Oxybenzone ACTIVE INGREDIENT 95OOS7VE0Y PURPOSE (OCTINOXATE, OCTISALATE AND OXYBENZONE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Octinoxate ACTIVE MOIETY 4Y5P7MUD51 PURPOSE (OCTINOXATE, OCTISALATE AND OXYBENZONE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Octisalate ACTIVE MOIETY 4X49Y0596W PURPOSE (OCTINOXATE, OCTISALATE AND OXYBENZONE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Oxybenzone ACTIVE MOIETY 95OOS7VE0Y PURPOSE (OCTINOXATE, OCTISALATE AND OXYBENZONE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Diazolidinyl Urea INACTIVE INGREDIENT H5RIZ3MPW4 PURPOSE (OCTINOXATE, OCTISALATE AND OXYBENZONE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Dimethicone INACTIVE INGREDIENT 92RU3N3Y1O PURPOSE (OCTINOXATE, OCTISALATE AND OXYBENZONE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Ethylparaben INACTIVE INGREDIENT 14255EXE39 PURPOSE (OCTINOXATE, OCTISALATE AND OXYBENZONE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX PURPOSE (OCTINOXATE, OCTISALATE AND OXYBENZONE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Glyceryl Monostearate INACTIVE INGREDIENT 230OU9XXE4 PURPOSE (OCTINOXATE, OCTISALATE AND OXYBENZONE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Levomenol INACTIVE INGREDIENT 24WE03BX2T PURPOSE (OCTINOXATE, OCTISALATE AND OXYBENZONE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T PURPOSE (OCTINOXATE, OCTISALATE AND OXYBENZONE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Octyldodecyl Neopentanoate INACTIVE INGREDIENT X8725R883T PURPOSE (OCTINOXATE, OCTISALATE AND OXYBENZONE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 PEG-100 Stearate INACTIVE INGREDIENT YD01N1999R PURPOSE (OCTINOXATE, OCTISALATE AND OXYBENZONE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH PURPOSE (OCTINOXATE, OCTISALATE AND OXYBENZONE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Trolamine INACTIVE INGREDIENT 9O3K93S3TK PURPOSE (OCTINOXATE, OCTISALATE AND OXYBENZONE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Water INACTIVE INGREDIENT 059QF0KO0R PURPOSE (OCTINOXATE, OCTISALATE AND OXYBENZONE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0187-5500-04 00187550004 1 BOTTLE, PUMP in 1 CARTON (0187-5500-04) > 118 mL in 1 BOTTLE, PUMP 2013-10-07 0000-00-00 No No Current