NDC Code(s) : 49967-900-01, 49967-900-02
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 Skin Renewing Broad Spectrum SPF 30 Dayoctinoxate and zinc oxide CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-900
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE75 mg in 1 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE105 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE(UNII: NMQ347994Z)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
PEG-40 STEARATE(UNII: ECU18C66Q7)
DIMETHICONE(UNII: 92RU3N3Y1O)
GLYCERIN(UNII: PDC6A3C0OX)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)(UNII: 86FQE96TZ4)
CERAMIDE NP(UNII: 4370DF050B)
CERAMIDE AP(UNII: F1X8L2B00J)
CERAMIDE 1(UNII: 5THT33P7X7)
POTASSIUM CETYL PHOSPHATE(UNII: 03KCY6P7UT)
SQUALANE(UNII: GW89575KF9)
PHYTOSPHINGOSINE(UNII: GIN46U9Q2Q)
CHOLESTEROL(UNII: 97C5T2UQ7J)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
HYDROGENATED PALM GLYCERIDES(UNII: YCZ8EM144Q)
BEHENTRIMONIUM METHOSULFATE(UNII: 5SHP745C61)
POLYSORBATE 60(UNII: CAL22UVI4M)
HYALURONIC ACID(UNII: S270N0TRQY)
RETINOL(UNII: G2SH0XKK91)
EDETATE DISODIUM(UNII: 7FLD91C86K)
XANTHAN GUM(UNII: TTV12P4NEE)
IRIS GERMANICA VAR. FLORENTINA ROOT(UNII: M30XO5X4XD)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
POLYSORBATE 20(UNII: 7T1F30V5YH)
CHLORPHENESIN(UNII: I670DAL4SZ)
SODIUM LAUROYL LACTYLATE(UNII: 7243K85WFO)
TETRAHEXYLDECYL ASCORBATE(UNII: 9LBV3F07AZ)
ALCOHOL(UNII: 3K9958V90M)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
SODIUM POLYACRYLATE (8000 MW)(UNII: 285CYO341L)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
CARBOXYPOLYMETHYLENE(UNII: 0A5MM307FC)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49967-900-011 in 1 CARTON 28/08/2017
150 g in 1 BOTTLE, PUMP Type 0: Not a Combination Product
2NDC:49967-900-025 g in 1 TUBE Type 0: Not a Combination Product28/08/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 08/28/2017

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

Establishment
Name Address ID/FEI Business Operations
Accupac, LLC 061595175 MANUFACTURE(49967-900)

PRINCIPAL DISPLAY PANEL

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