NDC Code(s) : 49967-015-01, 49967-015-02, 49967-015-03, 49967-015-04, 49967-015-05, 49967-015-06
Packager : L'Oreal USA Products, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CeraVe AM Facial Moisturizing Broad Spectrum SPF 30 SunscreenHomosalate, Meradimate, Octinoxate, Zinc Oxide, and Octocrylene LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-015
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Homosalate(UNII: V06SV4M95S)
(Homosalate - UNII:V06SV4M95S) 		Homosalate100 mg in 1 mL
MERADIMATE(UNII: J9QGD60OUZ)
(MERADIMATE - UNII:J9QGD60OUZ) 		MERADIMATE50 mg in 1 mL
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate50 mg in 1 mL
Octocrylene(UNII: 5A68WGF6WM)
(Octocrylene - UNII:5A68WGF6WM) 		Octocrylene20 mg in 1 mL
Zinc oxide(UNII: SOI2LOH54Z)
(Zinc oxide - UNII:SOI2LOH54Z) 		Zinc oxide63 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
NIACINAMIDE(UNII: 25X51I8RD4)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
GLYCERIN(UNII: PDC6A3C0OX)
DIMETHICONE(UNII: 92RU3N3Y1O)
BEHENTRIMONIUM METHOSULFATE(UNII: 5SHP745C61)
CERAMIDE 3(UNII: 4370DF050B)
CERAMIDE 6 II(UNII: F1X8L2B00J)
CERAMIDE 1(UNII: 5THT33P7X7)
HYALURONIC ACID(UNII: S270N0TRQY)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)(UNII: ZYD53NBL45)
METHYLPARABEN(UNII: A2I8C7HI9T)
EDETATE DISODIUM(UNII: 7FLD91C86K)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM LAUROYL LACTYLATE(UNII: 7243K85WFO)
PHYTOSPHINGOSINE(UNII: GIN46U9Q2Q)
CHOLESTEROL(UNII: 97C5T2UQ7J)
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: F68VH75CJC)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49967-015-011 in 1 CARTON 08/03/2017
189 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
2NDC:49967-015-021 in 1 CARTON 08/03/2017
260 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
3NDC:49967-015-035 mL in 1 TUBE Type 0: Not a Combination Product08/03/2017
4NDC:49967-015-041.5 mL in 1 PACKET Type 0: Not a Combination Product08/03/2017
5NDC:49967-015-051 in 1 CARTON 08/03/2017
550 mL in 1 BOTTLE Type 0: Not a Combination Product08/03/2017
6NDC:49967-015-061 in 1 CARTON 08/03/2017
6148 mL in 1 TUBE Type 0: Not a Combination Product08/03/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 08/03/2017

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

Establishment
Name Address ID/FEI Business Operations
L'Oreal USA Products, Inc. 624244349 MANUFACTURE(49967-015), pack(49967-015)

Establishment
Name Address ID/FEI Business Operations
Universal Packaging Systems, Inc. 078717086 pack(49967-015)

PRINCIPAL DISPLAY PANEL

image of a carton

image of a carton