CeraVe

Product NDC
0187-2224
11-digit product format
001872224
Labeler code
0187
Product ID
0187-2224_3f9e3054-76cc-480d-a051-10222256f6ee
Type
HUMAN OTC DRUG
Nonproprietary name
titanium dioxide and zinc oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Valeant Pharmaceuticals North America LLC
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-11-01
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
74 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0187-2224DDiscontinued by firm2026-10-15
excluded packagepackage0187-22240187-2224-01DDiscontinued 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 · 28 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0187-2224-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0187-2224-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0187-2224-01DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0187-2224-01DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0187-2224-01DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0187-2224-01DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0187-2224-01DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0187-2224-01DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0187-2224-01DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0187-2224-01DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0187-2224-01DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0187-2224-01DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0187-2224-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0187-2224-01IInactivated by FDA9bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0187-2224-012021-05-13C16284748780-19d75b9d0-5509-f424-e053-dadaa90a57ceDrug Facts
0187-2224-012020-01-31C16284748780-19d75b9d0-5509-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
ALUMINUM STEARATEINACTIVE INGREDIENTU6XF9NP8HMCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D3CERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
CAPRYLYL TRISILOXANEINACTIVE INGREDIENTQ95M2P1KJLCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
CERAMIDE 1INACTIVE INGREDIENT5THT33P7X7CERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
CERAMIDE 3INACTIVE INGREDIENT4370DF050BCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
CERAMIDE 6 IIINACTIVE INGREDIENTF1X8L2B00JCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
CETETH-20INACTIVE INGREDIENTI835H2IHHXCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
CETETH-25INACTIVE INGREDIENT5KLY4IOG20CERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7JCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
GLUCAMINEINACTIVE INGREDIENT5QN16UUF80CERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
GLYCERYL ISOSTEARATEINACTIVE INGREDIENTHYE7O27HAOCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4CERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
HYALURONIC ACIDINACTIVE INGREDIENTS270N0TRQYCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1ECERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U0062CERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
MICAINACTIVE INGREDIENTV8A1AW0880CERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4CERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
OLETH-25INACTIVE INGREDIENTR81LKU53DKCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
PEG-75 STEARATEINACTIVE INGREDIENTOT38R0N74HCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0FCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
PROPYLENE GLYCOL STEARATEINACTIVE INGREDIENTMZM1I680W0CERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
SAFFLOWER OILINACTIVE INGREDIENT65UEH262ISCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
SODIUM LAUROYL LACTYLATEINACTIVE INGREDIENT7243K85WFOCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E08CERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08ECERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
TRIETHYLHEXANOININACTIVE INGREDIENT7K3W1BIU6KCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RCERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECERAVE BABY SUNSCREEN BROAD SPECTRUM SPF 45 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]2