NDC Code(s) : 49967-805-01, 49967-805-02
Packager : L'Oreal USA Products Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CeraVe Developed with Dermatologists Baby MoisturizingDimethicone CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-805
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE12 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CETYL ALCOHOL(UNII: 936JST6JCN)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
PETROLATUM(UNII: 4T6H12BN9U)
CERAMIDE 3(UNII: 4370DF050B)
CERAMIDE AP(UNII: F1X8L2B00J)
CERAMIDE 1(UNII: 5THT33P7X7)
HYALURONIC ACID(UNII: S270N0TRQY)
CHOLESTEROL(UNII: 97C5T2UQ7J)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
BEHENTRIMONIUM METHOSULFATE(UNII: 5SHP745C61)
MONOBASIC POTASSIUM PHOSPHATE(UNII: 4J9FJ0HL51)
DIBASIC POTASSIUM PHOSPHATE(UNII: CI71S98N1Z)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
SODIUM LAUROYL LACTYLATE(UNII: 7243K85WFO)
EDETATE DISODIUM(UNII: 7FLD91C86K)
PHYTOSPHINGOSINE(UNII: GIN46U9Q2Q)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE(UNII: 0A5MM307FC)
XANTHAN GUM(UNII: TTV12P4NEE)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49967-805-01142 g in 1 TUBE Type 0: Not a Combination Product15/09/2017
2NDC:49967-805-0214.2 g in 1 TUBE Type 0: Not a Combination Product15/09/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M016 09/15/2017 05/31/2024

LABELER - L'Oreal USA Products Inc.(002136794)

Establishment
Name Address ID/FEI Business Operations
L'Oreal USA Products, Inc. 624244349 MANUFACTURE(49967-805)

PRINCIPAL DISPLAY PANEL

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