NDC Code(s) : 66915-619-01, 66915-619-02
Packager : CoValence, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Natural SPF 28 Soy FreeZinc Oxide 11.6%, Titanium Dioxide 0.67% CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66915-619
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION.116 g in 1 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE.0067 g in 1 g
Inactive Ingredients
Ingredient Name Strength
SUNFLOWER OIL(UNII: 3W1JG795YI)1 g in 1 g
WATER(UNII: 059QF0KO0R)1 g in 1 g
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)1 g in 1 g
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)1 g in 1 g
CETEARYL GLUCOSIDE(UNII: 09FUA47KNA)1 g in 1 g
COCO-CAPRYLATE/CAPRATE(UNII: 8D9H4QU99H)1 g in 1 g
POLYSORBATE 60(UNII: CAL22UVI4M)1 g in 1 g
GLYCERIN(UNII: PDC6A3C0OX)1 g in 1 g
SQUALANE(UNII: GW89575KF9)1 g in 1 g
POLYGLYCERYL-6 DIOLEATE(UNII: 062SZD3F3X)1 g in 1 g
ISONONYL ISONONANOATE(UNII: S4V5BS6GCX)1 g in 1 g
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)1 g in 1 g
XANTHAN GUM(UNII: TTV12P4NEE)1 g in 1 g
GLYCERYL ISOSTEARATE(UNII: HYE7O27HAO)1 g in 1 g
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)1 g in 1 g
ALUMINUM OXIDE(UNII: LMI26O6933)1 g in 1 g
.ALPHA.-TOCOPHEROL ACETATE, D-(UNII: A7E6112E4N)1 g in 1 g
ALOE VERA LEAF(UNII: ZY81Z83H0X)1 g in 1 g
DIMETHICONE(UNII: 92RU3N3Y1O)1 g in 1 g
ALLANTOIN(UNII: 344S277G0Z)1 g in 1 g
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)1 g in 1 g
TRISODIUM ETHYLENEDIAMINE DISUCCINATE(UNII: YA22H34H9Q)1 g in 1 g
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)1 g in 1 g
POPULUS TREMULOIDES BARK(UNII: 5543O0CEID)1 g in 1 g
DICAPRYLYL ETHER(UNII: 77JZM5516Z)1 g in 1 g
1,2-HEXANEDIOL(UNII: TR046Y3K1G)1 g in 1 g
CAPRYLYL GLYCOL(UNII: 00YIU5438U)1 g in 1 g
GLUCONOLACTONE(UNII: WQ29KQ9POT)1 g in 1 g
LONICERA CAPRIFOLIUM FLOWER(UNII: 5N1WD9784U)1 g in 1 g
LONICERA JAPONICA FLOWER(UNII: 4465L2WS4Y)1 g in 1 g
TROPOLONE(UNII: 7L6DL16P1T)1 g in 1 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66915-619-01200000 g in 1 DRUM 10/01/2014
2NDC:66915-619-0262.5 g in 1 TUBE 10/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 10/01/2014

PRINCIPAL DISPLAY PANEL

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