NDC Code 49967-900-01 | pharmacompass.com

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE(UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 g
ZINC OXIDE(UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	105 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49967-900-01	1 in 1 CARTON	28/08/2017
1		50 g in 1 BOTTLE, PUMP Type 0: Not a Combination Product
2	NDC:49967-900-02	5 g in 1 TUBE Type 0: Not a Combination Product	28/08/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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)

NDC 49967-900-01
API & Excipient Details

marketed by L'Oreal USA Products Inc. under NDC Code 49967-900-01

NDC Code(s) : 49967-900-01, 49967-900-02
Packager : L'Oreal USA Products Inc.

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

NDC 49967-900-01 API & Excipient Details

marketed by L'Oreal USA Products Inc. under NDC Code 49967-900-01

NDC Code(s) : 49967-900-01, 49967-900-02Packager : L'Oreal USA Products Inc.

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

NDC 49967-900-01
API & Excipient Details

NDC Code(s) : 49967-900-01, 49967-900-02
Packager : L'Oreal USA Products Inc.