FDA.reportPublic FDA data

CeraVe Developed with Dermatologists Heal and Protect Balm

Manufacturer
L'Oreal USA Products Inc
Effective date
2020-01-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:46:57

Label at a glance#

ProductCeraVe Developed with Dermatologists Heal and Protect Balm
Active ingredientDIMETHICONE
Label structure14 sections

Indications and uses

temporarily protects and helps relieve chafed, chapped or cracked skin helps protect from the drying effects of wind and cold weather

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects and helps relieve chafed, chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather

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

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

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

paraffin, ethylhexyl palmitate, petrolatum, butyrospermum parkii (shea) butter, ozokerite, euphorbia cerifera (candelilla) wax, cetyl alcohol, glycerin, tocopheryl acetate, ceteareth-25, behenic acid, cholesterol, ceramide 1, ceramide 3, ceramide 6-II, ceramide EOS, ceramide NS, caprooyl phytosphingosine, caprooyl sphingosine, ascorbyl palmitate, water, BHT, sodium hyaluronate

Questions or comments?

OTC - QUESTIONS SECTION

Toll-free number 1-888-768-2915

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-30149967-301-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
PARAFFINI9O0E3H2ZEIACT
ETHYLHEXYL PALMITATE2865993309IACT
PETROLATUM4T6H12BN9UIACT
SHEA BUTTERK49155WL9YIACT
CERESINQ1LS2UJO3AIACT
CANDELILLA WAXWL0328HX19IACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CETEARETH-258FA93U5T67IACT
BEHENIC ACIDH390488X0AIACT
CHOLESTEROL97C5T2UQ7JIACT
CERAMIDE 15THT33P7X7IACT
CERAMIDE 34370DF050BIACT
CERAMIDE 6 IIF1X8L2B00JIACT
CERAMIDE EOSCR0J8RN66KIACT
CERAMIDE NGC04977SRJ5IACT
N-HEXANOYLSPHINGOSINE038753E78JIACT
ASCORBYL PALMITATEQN83US2B0NIACT
WATER059QF0KO0RIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
HYALURONATE SODIUMYSE9PPT4THIACT

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
260fc7de-a719-4016-936e-5ae711bb16a04ef0fa76-9050-4112-9a07-802d6084c0e62020-01-02WarningsExact identifier
spl id: 260fc7de-a719-4016-936e-5ae711bb16a0
spl set id: 4ef0fa76-9050-4112-9a07-802d6084c0e6

Reported adverse events (FAERS/openFDA)#

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