NDC Code(s) : 66915-611-01, 66915-611-02, 66915-611-03
Packager : CoValence, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Daytime Defense SPF 30ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66915-611
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.135 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
ETHYL MACADAMIATE(UNII: ANA2NCS6V1)
ISODECYL NEOPENTANOATE(UNII: W60VYE24XC)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
BARLEY(UNII: 5PWM7YLI7R)
LAVENDER OIL(UNII: ZBP1YXW0H8)
SANDALWOOD(UNII: 3641YW25N2)
PHELLODENDRON AMURENSE BARK(UNII: PBG27B754G)
ARTEMISIA VULGARIS ROOT(UNII: 32MP823R8S)
.ALPHA.-TOCOPHEROL, DL-(UNII: 7QWA1RIO01)
MALIC ACID, L-(UNII: J3TZF807X5)
LONICERA CAPRIFOLIUM FLOWER(UNII: 5N1WD9784U)
LONICERA JAPONICA FLOWER(UNII: 4465L2WS4Y)
GLYCERYL ISOSTEARATE(UNII: HYE7O27HAO)
SODIUM STEAROYL LACTYLATE(UNII: IN99IT31LN)
DOCOSANOL(UNII: 9G1OE216XY)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
HAMAMELIS VIRGINIANA TOP WATER(UNII: NT00Y05A2V)
ALCOHOL(UNII: 3K9958V90M)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
FYTIC ACID(UNII: 7IGF0S7R8I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66915-611-01200000 g in 1 DRUM
2NDC:66915-611-0230 g in 1 BOTTLE, PLASTIC
3NDC:66915-611-03120 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 04/26/2012

PRINCIPAL DISPLAY PANEL

Principal Display Panel: 66915 611 02 Label