NDC Code(s) : 49967-014-01
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 Sunscreen Broad Spectrum SPF 50Titanium Dioxide, Zinc Oxide STICK
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-014
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 Dioxide0.80 g in 13.32 g
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide0.63 g in 13.32 g
Inactive Ingredients
Ingredient Name Strength
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
BUTYLOCTYL SALICYLATE(UNII: 2EH13UN8D3)
NEOPENTYL GLYCOL DIETHYLHEXANOATE(UNII: U68ZV6W62C)
PARAFFIN(UNII: I9O0E3H2ZE)
CANDELILLA WAX(UNII: WL0328HX19)
CERESIN(UNII: Q1LS2UJO3A)
DIMETHICONE(UNII: 92RU3N3Y1O)
YELLOW WAX(UNII: 2ZA36H0S2V)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
CETYL ALCOHOL(UNII: 936JST6JCN)
CERAMIDE NP(UNII: 4370DF050B)
CERAMIDE AP(UNII: F1X8L2B00J)
CERAMIDE 1(UNII: 5THT33P7X7)
CHOLESTEROL(UNII: 97C5T2UQ7J)
PHYTOSPHINGOSINE(UNII: GIN46U9Q2Q)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ISOSTEARIC ACID(UNII: X33R8U0062)
SODIUM LAUROYL LACTYLATE(UNII: 7243K85WFO)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49967-014-0113.32 g in 1 BLISTER PACK Type 0: Not a Combination Product11/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 11/01/2017

LABELER - L'Oreal USA Products Inc(002136794)

Establishment
Name Address ID/FEI Business Operations
Autumn Harp, Inc. 064187883 MANUFACTURE(49967-014)

PRINCIPAL DISPLAY PANEL

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