FDA.reportPublic FDA data

CeraVe Developed with Dermatologists Eczema Relief Moisturizing

Manufacturer
L'Oreal USA Products Inc
Effective date
2025-12-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:21:26

Label at a glance#

ProductCeraVe Developed with Dermatologists Eczema Relief Moisturizing
Active ingredientOATMEAL
Label structure11 sections

Indications and uses

temporarily protects and helps relieve minor skin irritation and itching due to: •eczema •rashes

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal oatmeal 1%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects and helps relieve minor skin irritation and itching due to: •eczema •rashes

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, butyrospermum parkii (shea) butter, glycerin, dimethicone, cetearyl
alcohol, niacinamide, caprylic/capric triglyceride, glyceryl stearate,
PEG-100 stearate, ammonium polyacryloyldimethyl taurate, ceramide NP,
ceramide AP, ceramide EOP, sorbitan tristearate, carbomer, cetearyl
isononanoate, behentrimonium methosulfate, triethyl citrate, sodium
benzoate, sodium lauroyl lactylate, sodium hyaluronate, cholesterol,
phenoxyethanol, tocopherol, citric acid, caprylyl glycol, trisodium
ethylenediamine disuccinate, xanthan gum, pentaerythrityl tetra-di-t-butyl
hydroxyhydrocinnamate, phytosphingosine, octyldodecanol, benzoic acid,
PEG-20 methyl glucose sesquistearate

Questions or comments?

OTC - QUESTIONS SECTION

Toll-free number 1-888-768-2915

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236 mL tube236 mL tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240651colloidal oatmeal 1 % Topical CreamPSN1
240651colloidal oatmeal 10 MG/ML Topical CreamSCD1
240651Avena sativa 1 % Topical CreamSY1
240651colloidal oatmeal 1 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codece.oaqr.io/01/03606000652040236 mL.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82046-040-01CeraVe Developed with Dermatologists Eczema Relief Moisturizing236 mL in 1 TUBECREAM2361

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82046-04082046-040-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YACTIB
WATER059QF0KO0RIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
CETEARYL ALCOHOL2DMT128M1SIACT
NIACINAMIDE25X51I8RD4IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
GLYCERYL STEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
AMMONIUM POLYACRYLOYLDIMETHYL TAURATEF01RIY4371IACT
CERAMIDE NP4370DF050BIACT
CERAMIDE APF1X8L2B00JIACT
SORBITAN TRISTEARATE6LUM696811IACT
CARBOMER0A5MM307FCIACT
CETEARYL ISONONANOATEP5O01U99NIIACT
BEHENTRIMONIUM METHOSULFATE5SHP745C61IACT
TRIETHYL CITRATE8Z96QXD6UMIACT
SODIUM BENZOATEOJ245FE5EUIACT
sodium lauroyl lactylate7243K85WFOIACT
sodium hyaluronateYSE9PPT4THIACT
cholesterol97C5T2UQ7JIACT
phenoxyethanolHIE492ZZ3TIACT
tocopherolR0ZB2556P8IACT
citric acid2968PHW8QPIACT
caprylyl glycol00YIU5438UIACT
trisodium ethylenediamine disuccinateYA22H34H9QIACT
xanthan gumTTV12P4NEEIACT
pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate255PIF62MSIACT
phytosphingosineGIN46U9Q2QIACT
octyldodecanol461N1O614YIACT
benzoic acid8SKN0B0MIMIACT
PEG-20 methyl glucose sesquistearate0345752X7UIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CeraVe Developed with Dermatologists Eczema Relief MoisturizingCOLLOIDAL OATMEALL'Oreal USA Products Incc4dde987-fe4e-4f8e-8f3a-1bc12c9588ed2025-12-09WarningsExact identifier
ndc (package): 82046-040-01
ndc (product): 82046-040
ndc11 (package): 82046004001
spl id: 3e662308-4562-4ed1-8650-de43767d6ac7
spl set id: c4dde987-fe4e-4f8e-8f3a-1bc12c9588ed

Reported adverse events (FAERS/openFDA)#

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