CERAVE BABY MOISTURIZING- dimethicone lotion
Bausch Health US, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CeraVe Baby Moisturizing Lotion

Drug Facts

Active ingredient

Dimethicone 1%

Purpose

Skin Protectant

Uses

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

Warnings

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.

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

Directions

•: apply as needed

Other information

•: do not freeze

Inactive ingredients

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

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

Package/Label Principal Display Panel

Back panel –

CeraVe Baby Moisturizing Lotion Back Label

CERAVE BABY MOISTURIZING
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0187-2219
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
NIACINAMIDE (UNII: 25X51I8RD4)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
HYALURONIC ACID (UNII: S270N0TRQY)
ALLANTOIN (UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAURIC ACID (UNII: 1160N9NU9U)
ZINC CITRATE (UNII: K72I3DEX9B)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632)
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)
EDETIC ACID (UNII: 9G34HU7RV0)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0187-2219-01	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2013	08/01/2017
2	NDC:0187-2219-02	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2013	08/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	12/01/2013	08/01/2017

Labeler - Bausch Health US, LLC (831922468)

Revised: 5/2021

Document Id: f46c800e-eb7e-4f00-8259-b720f9d2d4c7

Set id: a19c07af-d10c-4a25-b486-d1bfa2ab256c

Version: 4

Effective Time: 20210506

Bausch Health US, LLC