NDC Code(s) : 66915-608-01, 66915-608-02, 66915-608-06, 66915-608-03, 66915-608-04, 66915-608-05, 66915-608-07
Packager : CoValence, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SPF 20Zinc Oxide 15% CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66915-608
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.15 g in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)1 g in 1 g
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)1 g in 1 g
SUCROSE STEARATE(UNII: 274KW0O50M)1 g in 1 g
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)1 g in 1 g
C12-15 ALKYL BENZOATE(UNII: A9EJ3J61HQ)1 g in 1 g
GALACTOARABINAN(UNII: SL4SX1O487)1 g in 1 g
HYALURONATE SODIUM(UNII: YSE9PPT4TH)1 g in 1 g
TETRAHEXYLDECYL ASCORBATE(UNII: 9LBV3F07AZ)1 g in 1 g
CAPRYLHYDROXAMIC ACID(UNII: UPY805K99W)1 g in 1 g
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)1 g in 1 g
METHYLPROPANEDIOL(UNII: N8F53B3R4R)1 g in 1 g
TOCOPHEROL(UNII: R0ZB2556P8)1 g in 1 g
SOYBEAN OIL(UNII: 241ATL177A)1 g in 1 g
METHICONE (20 CST)(UNII: 6777U11MKT)1 g in 1 g
WITCH HAZEL(UNII: 101I4J0U34)1 g in 1 g
ALCOHOL(UNII: 3K9958V90M)1 g in 1 g
CITRIC ACID ACETATE(UNII: DSO12WL7AU)1 g in 1 g
PHYTIC ACID(UNII: 7IGF0S7R8I)1 g in 1 g
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)1 g in 1 g
CAPRYLYL GLYCOL(UNII: 00YIU5438U)1 g in 1 g
PHENETHYL ALCOHOL(UNII: ML9LGA7468)1 g in 1 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66915-608-01200000 g in 1 DRUM
2NDC:66915-608-061 in 1 CONTAINER
2NDC:66915-608-02102 g in 1 TUBE
3NDC:66915-608-03134 g in 1 TUBE
4NDC:66915-608-04529 g in 1 BOTTLE
5NDC:66915-608-071 in 1 KIT
5NDC:66915-608-0517 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 12/18/2013

PRINCIPAL DISPLAY PANEL

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