CERAVE DEVELOPED WITH DERMATOLOGISTS BABY MOISTURIZING- dimethicone lotion

CeraVe Developed with Dermatologists Baby Moisturizing by

Drug Labeling and Warnings

CeraVe Developed with Dermatologists Baby Moisturizing by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAVE DEVELOPED WITH DERMATOLOGISTS BABY MOISTURIZING 
dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-190
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
NIACINAMIDE (UNII: 25X51I8RD4)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (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)
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z)
EDETIC ACID (UNII: 9G34HU7RV0)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-190-01	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/17/2017
2	NDC: 49967-190-02	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/17/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	08/17/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA Products, Inc.		624244349	MANUFACTURE(49967-190)