NDC Code(s) : 66915-612-01, 66915-612-02
Packager : CoValence, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DNA Prime Natural SPF 45Zinc Oxide, Titanium Dioxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66915-612
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE.225 mg in 1 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE.02 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
C12-15 ALKYL BENZOATE(UNII: A9EJ3J61HQ)
CETYL ALCOHOL(UNII: 936JST6JCN)
DOCOSANOL(UNII: 9G1OE216XY)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
ARGAN OIL(UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE, D-(UNII: A7E6112E4N)
GLYCERIN(UNII: PDC6A3C0OX)
ISOSTEARIC ACID(UNII: X33R8U0062)
EPIGALLOCATECHIN GALLATE(UNII: BQM438CTEL)
RESVERATROL(UNII: Q369O8926L)
COCONUT ALKANES(UNII: 1E5KJY107T)
COCO-CAPRYLATE/CAPRATE(UNII: 8D9H4QU99H)
POPULUS TREMULOIDES BARK(UNII: 5543O0CEID)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE(UNII: D2QHA03458)
ORANGE OIL(UNII: AKN3KSD11B)
LEMON OIL(UNII: I9GRO824LL)
GRAPEFRUIT OIL(UNII: YR377U58W9)
LEVOMENOL(UNII: 24WE03BX2T)
TROPOLONE(UNII: 7L6DL16P1T)
VANILLIN(UNII: CHI530446X)
GLUCONOLACTONE(UNII: WQ29KQ9POT)
LONICERA JAPONICA FLOWER(UNII: 4465L2WS4Y)
LONICERA CAPRIFOLIUM FLOWER(UNII: 5N1WD9784U)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
XANTHAN GUM(UNII: TTV12P4NEE)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66915-612-0130 g in 1 BOTTLE, PLASTIC
2NDC:66915-612-02200000 g in 1 DRUM
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 07/29/2014

PRINCIPAL DISPLAY PANEL

PDP

Principal Display Panel