NDC Code(s) : 69842-045-02
Packager : CVS

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Retinol Day SPF 30 Avobenzone 3.00% Octinoxate 7.50% Octisalate 5.00% Octocrylene 2.70% Oxybenzone 4.00% CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69842-045
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		Avobenzone3 g in 100 mL
Octinoxate(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		Octinoxate7.5 g in 100 mL
Octisalate(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		Octisalate5 g in 100 mL
Octocrylene(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		Octocrylene2.7 g in 100 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE4 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Glycerin(UNII: PDC6A3C0OX)
Dimethicone(UNII: 92RU3N3Y1O)
Ethylhexyl Methoxycrylene(UNII: S3KFG6Q5X8)
Neopentyl Glycol Diheptanoate(UNII: 5LKW3C543X)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
Butylene Glycol(UNII: 3XUS85K0RA)
Isostearyl Neopentanoate(UNII: 411THY156Q)
PPG-2 Isoceteth-20 Acetate(UNII: BI6C7YO419)
POLY(METHYL METHACRYLATE; 450000 MW)(UNII: Z47NNT4J11)
SODIUM ACRYLOYLDIMETHYLTAURATE(UNII: 2T9Q6EKI0G)
Bakuchiol(UNII: OT12HJU3AR)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
LEVOMENOL(UNII: 24WE03BX2T)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
SORBITAN MONOOLEATE(UNII: 06XEA2VD56)
Retinol(UNII: G2SH0XKK91)
Hydroxypinacolone Retinoate(UNII: NJ3V2F02E1)
Palmitoyl Oligopeptide(UNII: HO4ZT5S86C)
Palmitoyl Tetrapeptide-7(UNII: Q41S464P1R)
Tocopherol(UNII: R0ZB2556P8)
Sodium Ascorbate(UNII: S033EH8359)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 809Y72KV36)
DOCOSANOL(UNII: 9G1OE216XY)
Sodium Lactate(UNII: TU7HW0W0QT)
Ethylhexylglycerin(UNII: 147D247K3P)
Isohexadecane(UNII: 918X1OUF1E)
Polysorbate 80(UNII: 6OZP39ZG8H)
Polysorbate 20(UNII: 7T1F30V5YH)
Dimethyl Isosorbide(UNII: SA6A6V432S)
Xanthan Gum(UNII: TTV12P4NEE)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)(UNII: Z135WT9208)
EDETATE DISODIUM(UNII: 7FLD91C86K)
Sodium Hydroxide(UNII: 55X04QC32I)
Pentylene glycol(UNII: 50C1307PZG)
Chlorphenesin(UNII: I670DAL4SZ)
Phenoxyethanol(UNII: HIE492ZZ3T)
Caprylyl Glycol(UNII: 00YIU5438U)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
Potassium Sorbate(UNII: 1VPU26JZZ4)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69842-045-021 in 1 CARTON 26/12/2014
150 mL in 1 TUBE 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 12/26/2014

PRINCIPAL DISPLAY PANEL

image description