NDC Code(s) : 66915-613-01, 66915-613-02, 66915-613-03, 66915-613-04, 66915-613-06, 66915-613-07
Packager : CoValence, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Unscented SPF 17Zinc Oxide 7% CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66915-613
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.07 g in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)1 g in 1 g
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)1 g in 1 g
CETEARYL OLIVATE(UNII: 58B69Q84JO)1 g in 1 g
GLYCERIN(UNII: PDC6A3C0OX)1 g in 1 g
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)1 g in 1 g
SORBITAN OLIVATE(UNII: MDL271E3GR)1 g in 1 g
SQUALANE(UNII: GW89575KF9)1 g in 1 g
WHEAT GERM OIL(UNII: 14C97E680P)1 g in 1 g
OLIVE OIL(UNII: 6UYK2W1W1E)1 g in 1 g
JOJOBA OIL(UNII: 724GKU717M)1 g in 1 g
ASTAXANTHIN(UNII: 8XPW32PR7I)1 g in 1 g
.ALPHA.-TOCOPHEROL, D-(UNII: N9PR3490H9)1 g in 1 g
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)1 g in 1 g
TETRAHYDRODIFERULOYLMETHANE(UNII: 00U0645U03)1 g in 1 g
TETRAHYDROBISDEMETHOXYDIFERULOYLMETHANE(UNII: 973IBV8W7I)1 g in 1 g
TETRAHYDRODEMETHOXYDIFERULOYLMETHANE(UNII: 44D8X9U00T)1 g in 1 g
SOYBEAN OIL(UNII: 241ATL177A)1 g in 1 g
POPULUS TREMULOIDES BARK(UNII: 5543O0CEID)1 g in 1 g
TROPOLONE(UNII: 7L6DL16P1T)1 g in 1 g
TOCOTRIENOLS(UNII: KP2MW85SSQ)1 g in 1 g
LONICERA JAPONICA FLOWER(UNII: 4465L2WS4Y)1 g in 1 g
LONICERA CAPRIFOLIUM FLOWER(UNII: 5N1WD9784U)1 g in 1 g
GLUCONOLACTONE(UNII: WQ29KQ9POT)1 g in 1 g
PALM OIL(UNII: 5QUO05548Z)1 g in 1 g
GLYCERYL ISOSTEARATE(UNII: HYE7O27HAO)1 g in 1 g
CAPRYLYL GLYCOL(UNII: 00YIU5438U)1 g in 1 g
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)1 g in 1 g
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)1 g in 1 g
1,2-HEXANEDIOL(UNII: TR046Y3K1G)1 g in 1 g
ALCOHOL(UNII: 3K9958V90M)1 g in 1 g
XANTHAN GUM(UNII: TTV12P4NEE)1 g in 1 g
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)1 g in 1 g
PHYTIC ACID(UNII: 7IGF0S7R8I)1 g in 1 g
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)1 g in 1 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66915-613-01200000 g in 1 DRUM
2NDC:66915-613-02270 g in 1 BOTTLE, PLASTIC
3NDC:66915-613-0380 g in 1 BOTTLE, PLASTIC
4NDC:66915-613-061 in 1 BOX
4NDC:66915-613-0430 g in 1 JAR
5NDC:66915-613-071 g in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 08/12/2013

PRINCIPAL DISPLAY PANEL

66915 613 01 label