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Drug Facts

Manufacturer
L'Oreal USA Products Inc | Beauty Manufacturing Solutions Corp.
Effective date
2026-05-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:58:01

Label at a glance#

ProductCeraVe Developed with Dermatologists Healing Lip Balm
Active ingredientPETROLATUM
Label structure8 sections

Indications and uses

temporarily protects and helps relieve chafed, chapped or cracked lips 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

Petrolatum 49.5%

Purpose

OTC - PURPOSE SECTION

Lip protectant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

mineral oil, microcrystalline wax, glycerin, paraffin, synthetic wax, ceramide NP, ceramide AP, ceramide EOP, carbomer, water, triethyl citrate, sodium lauroyl lactylate, sodium hyaluronate, cholesterol, tocopheryl acetate, tocopherol, caprylyl glycol, panthenol, phytosphingosine, xanthan gum, benzoic acid

Questions or comments?

OTC - QUESTIONS SECTION

Toll-Free Number 1-888-768-2915

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DF 9gDF 9gtubetubecarton 1carton 1carton 2carton 2cartoncarton

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
82046-483-01CeraVe Developed with Dermatologists Healing Lip Balm9 g in 1 TUBECREAM92
82046-483-01CeraVe Developed with Dermatologists Healing Lip Balm1 in 1 CARTONCREAM12
82046-483-02CeraVe Developed with Dermatologists Healing Lip Balm2 in 1 CARTONCREAM22
82046-483-02CeraVe Developed with Dermatologists Healing Lip Balm9 g in 1 TUBECREAM92

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82046-48382046-483-01, 82046-483-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
GLYCERINPDC6A3C0OXIACT
PARAFFINI9O0E3H2ZEIACT
SYNTHETIC WAX (1200 MW)Q3Z4BCH099IACT
CERAMIDE NP4370DF050BIACT
CERAMIDE APF1X8L2B00JIACT
CARBOMER0A5MM307FCIACT
WATER059QF0KO0RIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
SODIUM HYALURONATEYSE9PPT4THIACT
CHOLESTEROL97C5T2UQ7JIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TOCOPHEROLR0ZB2556P8IACT
CAPRYLYL GLYCOL00YIU5438UIACT
PANTHENOLWV9CM0O67ZIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
XANTHAN GUMTTV12P4NEEIACT
BENZOIC ACID8SKN0B0MIMIACT
PETROLATUM4T6H12BN9UACTIB

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 Healing Lip BalmPETROLATUML'Oreal USA Products Inc21dc8842-0672-4d46-bcea-b8e3d54c48bf2026-05-20WarningsExact identifier
ndc (package): 82046-483-02
ndc (package): 82046-483-01
ndc (product): 82046-483
ndc11 (package): 82046048301
ndc11 (package): 82046048302
spl id: 523fd16e-da76-e6ff-e063-6394a90abded
spl set id: 21dc8842-0672-4d46-bcea-b8e3d54c48bf

Reported adverse events (FAERS/openFDA)#

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