FDA.reportPublic FDA data

CeraVe Baby Moisturizing Lotion

Manufacturer
Valeant Pharmaceuticals North America LLC | Product Quest Mfg, LLC
Effective date
2016-04-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:27:40

Label at a glance#

ProductCeraVe Baby Moisturizing
Active ingredientDIMETHICONE
Label structure9 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 Other information ▪ do not freeze

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

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

  • do not get into eyes

Stop use and ask a doctor if

  • 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

Other information

  • do not freeze

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water, caprylic/capric triglyceride, cetostearyl alcohol, cetyl alcohol, emulsifying wax, phenoxyethanol,niacinamide, ceramide 3, ceramide 6-II, ceramide 1, hyaluronic acid, allantoin, tocopheryl acetate, lauric acid, zinc citrate, polyglyceryl-3 diisostearate, bBehentrimonium methosulfate, sodium lauroyl lactylate, arginine PCA, potassium phosphate, dipotassium phosphate, EDTA, sodium PCA, phytosphingosine, cholesterol, xanthan gum, carbomer, ethylhexylglycerin

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

CeraVe®

DEVELOPED WITH DERMATOLOGISTS

baby

Moisturizing
Lotion

Protects and maintains baby’s

delicate skin barrier

With essential ceramides

& vitamins

Moisturizes 24 hours

Paraben, sulfate & fragrance free

8 FL OZ (237 mL)

VNT-BABY8-30

CeraVe Moisturizing Lotion
CeraVe Moisturizing Lotion

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Back panel –

CeraVe Baby Moisturizing Lotion Back Label
CeraVe Baby Moisturizing Lotion Back Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0187-2219-012021-05-05C16284748780-19d75b9d0-782e-f424-e053-dadaa90a57ceCeraVe Baby Moisturizing Lotion
0187-2219-022021-05-05C16284748780-19d75b9d0-782e-f424-e053-dadaa90a57ceCeraVe Baby Moisturizing Lotion
0187-2219-012020-01-31C16284748780-19d75b9d0-782e-f424-e053-dadaa90a57ceCeraVe Baby Moisturizing Lotion
0187-2219-022020-01-31C16284748780-19d75b9d0-782e-f424-e053-dadaa90a57ceCeraVe Baby Moisturizing Lotion

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-2219-01ML - Milliliter0187-221974ac3b0b-43d4-4d37-b353-2c92c9975a6112015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O1
DIMETHICONEACTIVE MOIETY92RU3N3Y1O1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ALLANTOININACTIVE INGREDIENT344S277G0Z1
BEHENTRIMONIUM METHOSULFATEINACTIVE INGREDIENT5SHP745C611
CERAMIDE 3INACTIVE INGREDIENT4370DF050B1
CERAMIDE 6 IIINACTIVE INGREDIENTF1X8L2B00J1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7J1
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV01
HYALURONIC ACIDINACTIVE INGREDIENTS270N0TRQY1
LAURIC ACIDINACTIVE INGREDIENT1160N9NU9U1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD41
PHYTOSPHINGOSINEINACTIVE INGREDIENTGIN46U9Q2Q1
POLYGLYCERYL-3 DIISOSTEARATEINACTIVE INGREDIENT46P231IQV81
POTASSIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTCI71S98N1Z1
POTASSIUM PHOSPHATE, UNSPECIFIED FORMINACTIVE INGREDIENTB7862WZ6321
SODIUM LAUROYL LACTYLATEINACTIVE INGREDIENT7243K85WFO1
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A21
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1
ZINC CITRATEINACTIVE INGREDIENTK72I3DEX9B1

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0187-22190187-2219-01, 0187-2219-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
PHENOXYETHANOLHIE492ZZ3TIACT
NIACINAMIDE25X51I8RD4IACT
CERAMIDE 34370DF050BIACT
CERAMIDE 6 IIF1X8L2B00JIACT
HYALURONIC ACIDS270N0TRQYIACT
ALLANTOIN344S277G0ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LAURIC ACID1160N9NU9UIACT
ZINC CITRATEK72I3DEX9BIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
BEHENTRIMONIUM METHOSULFATE5SHP745C61IACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
POTASSIUM PHOSPHATE, UNSPECIFIED FORMB7862WZ632IACT
POTASSIUM PHOSPHATE, DIBASICCI71S98N1ZIACT
EDETIC ACID9G34HU7RV0IACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
CHOLESTEROL97C5T2UQ7JIACT
XANTHAN GUMTTV12P4NEEIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 116 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETIC ACIDEDETIC ACID9G34HU7RV0TABLET, FILM COATED / ORAL0.2 mgExact identifier — unii candidate
13 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, CHEWABLE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii candidate
29 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS990.3 mgExact identifier — unii candidate
18 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SOINTMENT / TOPICAL1.2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCAPSULE, DELAYED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
CHOLESTEROLCHOLESTEROL97C5T2UQ7JINJECTABLE, LIPOSOMAL / INFILTRATION0.47 %w/vExact identifier — unii candidate
10 equally ranked IID candidates
NIACINAMIDENIACINAMIDE25X51I8RD4CREAM / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / VAGINAL0.75 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
CHOLESTEROLCHOLESTEROL97C5T2UQ7JINJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS0.32 %w/vExact identifier — unii candidate
10 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, FILM COATED / ORAL0.08 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / RECTAL452 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii candidate
29 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii candidate
20 equally ranked IID candidates
CHOLESTEROLCHOLESTEROL97C5T2UQ7JLOTION / TOPICAL20 mgExact identifier — unii candidate
10 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, ORALLY DISINTEGRATING / ORAL9 mgExact identifier — unii candidate
20 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, COATED / ORAL0.25 mgExact identifier — unii candidate
20 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SLOTION / TOPICAL3627 mgExact identifier — unii candidate
9 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SOLUTION / ORAL10 mg/5mlExact identifier — unii candidate
29 equally ranked IID candidates
CHOLESTEROLCHOLESTEROL97C5T2UQ7JCREAM / VAGINAL0.3 %w/wExact identifier — unii candidate
10 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0SUSPENSION / TOPICAL0.06 %w/vExact identifier — unii candidate
13 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UGEL / TOPICAL12 mgExact identifier — unii candidate
18 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER / SUBLINGUAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
NIACINAMIDENIACINAMIDE25X51I8RD4GEL / TOPICAL25 mgExact identifier — unii candidate
4 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPASTE / ORAL1050 mgExact identifier — unii candidate
29 equally ranked IID candidates
CHOLESTEROLCHOLESTEROL97C5T2UQ7JINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS52 mgExact identifier — unii candidate
10 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USUSPENSION / ORAL10170 mgExact identifier — unii candidate
18 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
POTASSIUM PHOSPHATE, DIBASICDIBASIC POTASSIUM PHOSPHATECI71S98N1ZSYRUP / ORAL22 mg/5mlExact identifier — unii candidate
8 equally ranked IID candidates
CHOLESTEROLCHOLESTEROL97C5T2UQ7JINJECTION / INTRAVENOUS93 mgExact identifier — unii candidate
10 equally ranked IID candidates
CHOLESTEROLCHOLESTEROL97C5T2UQ7JOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
10 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, EXTENDED RELEASE / ORAL132 mgExact identifier — unii candidate
20 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0SUPPOSITORY / RECTAL7 mgExact identifier — unii candidate
13 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SSUPPOSITORY / VAGINALNAExact identifier — unii candidate
9 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1STABLET, EXTENDED RELEASE / ORAL800 mgExact identifier — unii candidate
9 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0INJECTION, SOLUTION / SUBMUCOSAL0.03 %w/vExact identifier — unii candidate
13 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0GEL / TOPICAL0.1 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER / ORAL275 mgExact identifier — unii candidate
29 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UCAPSULE / ORAL4771 mgExact identifier — unii candidate
18 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0TABLET / ORAL4 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PYRROLIDONE CARBOXYLATESODIUM PYRROLIDONE CARBOXYLATE469OTG57A2LOTION / TOPICAL42 mgExact identifier — unii candidate
EDETIC ACIDEDETIC ACID9G34HU7RV0SUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
13 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY, METERED / SUBLINGUAL110 mgExact identifier — unii candidate
18 equally ranked IID candidates
CHOLESTEROLCHOLESTEROL97C5T2UQ7JINJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL7 mgExact identifier — unii candidate
10 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION / ORAL450 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / TOPICAL0.11 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
POTASSIUM PHOSPHATE, DIBASICDIBASIC POTASSIUM PHOSPHATECI71S98N1ZSOLUTION / ORAL890 mgExact identifier — unii candidate
8 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
NIACINAMIDENIACINAMIDE25X51I8RD4INJECTION / INTRAMUSCULAR2.5 %w/vExact identifier — unii candidate
4 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0INJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
13 equally ranked IID candidates

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
f46c800e-eb7e-4f00-8259-b720f9d2d4c7a19c07af-d10c-4a25-b486-d1bfa2ab256c2021-05-06WarningsExact identifier
spl set id: a19c07af-d10c-4a25-b486-d1bfa2ab256c

Reported adverse events (FAERS/openFDA)#

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