Home NDC 0187-1365 CeraVe
Product NDC 0187-1365
11-digit product format 001871365
Labeler code 0187
Product ID 0187-1365_b1c8c075-6fa4-426d-b937-ce5cbe112898
Type HUMAN OTC DRUG
Nonproprietary name Homosalate, Meradimate, Octinoxate, Zinc Oxide, and Octocrylene
Dosage form LOTION
Route TOPICAL
Labeler Valeant Pharmaceuticals North America LLC
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-06-15
Marketing end 0000-00-00
Substance HOMOSALATE; MERADIMATE; OCTINOXATE; OCTOCRYLENE; ZINC OXIDE
Active strength 100 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag E
Listing certified through 2017-12-31
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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0187-1365-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0187-1365-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0187-1365-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0187-1365-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0187-1365-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0187-1365-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0187-1365-01 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0187-1365-01 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0187-1365-01 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0187-1365-01 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0187-1365-01 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0187-1365-01 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 0187-1365-01 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0187-1365-01 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 0187-1365-01 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Homosalate ACTIVE INGREDIENT V06SV4M95S CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 MERADIMATE ACTIVE INGREDIENT J9QGD60OUZ CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Octinoxate ACTIVE INGREDIENT 4Y5P7MUD51 CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Octocrylene ACTIVE INGREDIENT 5A68WGF6WM CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Zinc oxide ACTIVE INGREDIENT SOI2LOH54Z CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Homosalate ACTIVE MOIETY V06SV4M95S CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 MERADIMATE ACTIVE MOIETY J9QGD60OUZ CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Octinoxate ACTIVE MOIETY 4Y5P7MUD51 CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Octocrylene ACTIVE MOIETY 5A68WGF6WM CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 Zinc oxide ACTIVE MOIETY SOI2LOH54Z CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 ALUMINUM STARCH OCTENYLSUCCINATE INACTIVE INGREDIENT I9PJ0O6294 CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 BEHENTRIMONIUM METHOSULFATE INACTIVE INGREDIENT 5SHP745C61 CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT F68VH75CJC CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 CERAMIDE 1 INACTIVE INGREDIENT 5THT33P7X7 CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 CERAMIDE 3 INACTIVE INGREDIENT 4370DF050B CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 CERAMIDE 6 II INACTIVE INGREDIENT F1X8L2B00J CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 CHOLESTEROL INACTIVE INGREDIENT 97C5T2UQ7J CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 HYALURONIC ACID INACTIVE INGREDIENT S270N0TRQY CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) INACTIVE INGREDIENT ZYD53NBL45 CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 NIACINAMIDE INACTIVE INGREDIENT 25X51I8RD4 CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 PHYTOSPHINGOSINE INACTIVE INGREDIENT GIN46U9Q2Q CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 SODIUM LAUROYL LACTYLATE INACTIVE INGREDIENT 7243K85WFO CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CERAVE AM BROAD SPECTRUM SUNSCREEN SPF 30 (HOMOSALATE, MERADIMATE, OCTINOXATE, ZINC OXIDE, AND OCTOCRYLENE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 1