NDC Code(s) : 58411-352-50
Packager : REVIVE SKINCARE

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

REVIVE MOISTURIZING RENEWALAVOBENZONE and OCTINOXATE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-352
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE1500 mg in 50 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE3746 mg in 50 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Cyclomethicone 5(UNII: 0THT5PCI0R)
Glycerin(UNII: PDC6A3C0OX)
Medium-Chain Triglycerides(UNII: C9H2L21V7U)
Glyceryl Trioleate(UNII: O05EC62663)
Butylene Glycol(UNII: 3XUS85K0RA)
Pentylene Glycol(UNII: 50C1307PZG)
Oleyl Erucate(UNII: 753W099NQ6)
Cetostearyl Alcohol(UNII: 2DMT128M1S)
Glyceryl Monostearate(UNII: 230OU9XXE4)
Dimethicone(UNII: 92RU3N3Y1O)
Hydrogenated Polybutene (1300 Mw)(UNII: 7D1YQ9Y5EZ)
Isopropyl Isostearate(UNII: C67IXB9Y7T)
PEG-100 Stearate(UNII: YD01N1999R)
Hyaluronate Sodium(UNII: YSE9PPT4TH)
.Alpha.-Tocopherol Acetate, DL-(UNII: WR1WPI7EW8)
.Alpha.-Tocopherol(UNII: H4N855PNZ1)
Chondrus Crispus Carrageenan(UNII: UE856F2T78)
Microcrystalline Cellulose(UNII: OP1R32D61U)
C14-22 Alcohols(UNII: B1K89384RJ)
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S at 1.5%)(UNII: 86FQE96TZ4)
Squalane(UNII: GW89575KF9)
Ammonium Acryloyldimethyltaurate/VP Copolymer(UNII: W59H9296ZG)
Tetrahexyldecyl Ascorbate(UNII: 9LBV3F07AZ)
Cetyl Alcohol(UNII: 936JST6JCN)
Allantoin(UNII: 344S277G0Z)
Carnosine(UNII: 8HO6PVN24W)
Edetate Disodium(UNII: 7FLD91C86K)
C12-20 Alkyl Glucoside(UNII: K67N5Z1RUA)
PEG-75 Stearate(UNII: OT38R0N74H)
Silibinin(UNII: 4RKY41TBTF)
Carboxymethylcellulose Sodium, Unspecified Form(UNII: K679OBS311)
Ethylhexylglycerin(UNII: 147D247K3P)
Cetearyl Glucoside(UNII: 09FUA47KNA)
Polysorbate 60(UNII: CAL22UVI4M)
Ceteth-20(UNII: I835H2IHHX)
Steareth-20(UNII: L0Q8IK9E08)
Adenosine(UNII: K72T3FS567)
Sorbitan Isostearate(UNII: 01S2G2C1E4)
Tert-Butyl Alcohol(UNII: MD83SFE959)
Gluconolactone(UNII: WQ29KQ9POT)
Potassium Sorbate(UNII: 1VPU26JZZ4)
Soybean Oil(UNII: 241ATL177A)
Sodium Oleate(UNII: 399SL044HN)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
Phenoxyethanol(UNII: HIE492ZZ3T)
Sodium Benzoate(UNII: OJ245FE5EU)
Geraniol(UNII: L837108USY)
.Alpha.-Hexylcinnamaldehyde(UNII: 7X6O37OK2I)
Hydroxycitronellal(UNII: 8SQ0VA4YUR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58411-352-501 in 1 CARTON 10/01/2017
150 g in 1 JAR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 10/01/2017

LABELER - REVIVE SKINCARE(193691821)

PRINCIPAL DISPLAY PANEL

MOISTURIZING
RENEWAL CREAM

RéVive

Broad Spectrum SPF 15 Sunscreen

50 g / net wt. 1.7 oz.

Principal Display Panel - 50 g Jar Carton