NDC Code(s) : 49967-150-01, 49967-150-02, 49967-150-03
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 HYDRATING SUNSCREEN SPF 30 FACE LIGHTWEIGHT, NON-GREASY FEEL 3 ESSENTIAL CERAMIDES NIACINAMIDE MINERAL SUNSCREENTitanium dioxide and zinc oxide LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-150
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE60 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
DIMETHICONE(UNII: 92RU3N3Y1O)
ISODODECANE(UNII: A8289P68Y2)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
BUTYLOCTYL SALICYLATE(UNII: 2EH13UN8D3)
PROPANEDIOL(UNII: 5965N8W85T)
STEARIC ACID(UNII: 4ELV7Z65AP)
PEG-100 STEARATE(UNII: YD01N1999R)
SORBITAN MONOSTEARATE(UNII: NVZ4I0H58X)
NIACINAMIDE(UNII: 25X51I8RD4)
PEG-8 LAURATE(UNII: 762O8IWA10)
CERAMIDE NP(UNII: 4370DF050B)
CERAMIDE AP(UNII: F1X8L2B00J)
CERAMIDE 1(UNII: 5THT33P7X7)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
CARBOXYPOLYMETHYLENE(UNII: 0A5MM307FC)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SODIUM LAUROYL LACTYLATE(UNII: 7243K85WFO)
SODIUM DODECYLBENZENESULFONATE(UNII: 554127163Y)
MYRISTIC ACID(UNII: 0I3V7S25AW)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
CHOLESTEROL(UNII: 97C5T2UQ7J)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
PALMITIC ACID(UNII: 2V16EO95H1)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CHLORPHENESIN(UNII: I670DAL4SZ)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)(UNII: 86FQE96TZ4)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
CITRIC ACID ACETATE(UNII: DSO12WL7AU)
PANTHENOL(UNII: WV9CM0O67Z)
XANTHAN GUM(UNII: TTV12P4NEE)
PHYTOSPHINGOSINE(UNII: GIN46U9Q2Q)
POLYHYDROXYSTEARIC ACID STEARATE(UNII: 8KQ7I65XZE)
POLYSORBATE 60(UNII: CAL22UVI4M)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49967-150-011 in 1 CARTON 02/01/2019
175 mL in 1 TUBE Type 0: Not a Combination Product
2NDC:49967-150-025 mL in 1 TUBE Type 0: Not a Combination Product02/01/2019
3NDC:49967-150-032.5 mL in 1 TUBE Type 0: Not a Combination Product02/01/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 02/01/2019

LABELER - L'Oreal USA Products Inc(002136794)

Establishment
Name Address ID/FEI Business Operations
L'OREAL USA PRODUCTS, INC. 624244349 manufacture(49967-150)

PRINCIPAL DISPLAY PANEL

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