NDC Code(s) : 66915-602-07, 66915-602-11, 66915-602-21, 66915-602-24, 66915-602-25, 66915-602-26, 66915-602-27, 66915-602-31, 66915-602-32, 66915-602-38, 66915-602-39, 66915-602-40
Packager : CoValence, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sol ProtectZinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66915-602
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.0702 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)1 g in 1 g
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE(UNII: U73D397055)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
OLEA EUROPAEA FRUIT VOLATILE OIL(UNII: 8E7358CX1J)1 g in 1 g
JOJOBA OIL(UNII: 724GKU717M)1 g in 1 g
ASTAXANTHIN(UNII: 8XPW32PR7I)1 g in 1 g
.ALPHA.-TOCOPHEROL ACETATE, D-(UNII: A7E6112E4N)1 g in 1 g
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)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
ELAEIS GUINEENSIS FRUIT BUTTER(UNII: UYH3R74N56)1 g in 1 g
GLYCERYL ISOSTEARATE(UNII: HYE7O27HAO)1 g in 1 g
CARBOMER 1342(UNII: 809Y72KV36)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 ACETATE(UNII: DSO12WL7AU)1 g in 1 g
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)1 g in 1 g
EDETATE SODIUM(UNII: MP1J8420LU)1 g in 1 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66915-602-07200000 g in 1 DRUM
2NDC:66915-602-1135 g in 1 JAR
3NDC:66915-602-2130 g in 1 BOTTLE, PLASTIC
4NDC:66915-602-2450 g in 1 JAR
5NDC:66915-602-2515 g in 1 BOTTLE, PLASTIC
6NDC:66915-602-2630 g in 1 TUBE
7NDC:66915-602-27100 g in 1 BOTTLE, PLASTIC
8NDC:66915-602-31180 g in 1 TUBE
9NDC:66915-602-3230 g in 1 BOTTLE, PLASTIC
10NDC:66915-602-3830 g in 1 BOTTLE, GLASS
11NDC:66915-602-3930 g in 1 BOTTLE, PLASTIC
12NDC:66915-602-4015 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 08/01/2011

PRINCIPAL DISPLAY PANEL

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