NDC Code(s) : 63433-451-51, 63433-451-79
Packager : DHC USA Incorporated

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DHC White SunscreenTitanium Dioxide and Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63433-451
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide(UNII: 15FIX9V2JP)
(Titanium Dioxide - UNII:15FIX9V2JP) 		Titanium Dioxide50 mg in 1 g
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide100 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Cyclomethicone 5(UNII: 0THT5PCI0R)
Water(UNII: 059QF0KO0R)
Talc(UNII: 7SEV7J4R1U)
Dimethicone(UNII: 92RU3N3Y1O)
Triethylhexanoin(UNII: 7K3W1BIU6K)
Glycerin(UNII: PDC6A3C0OX)
Pentylene Glycol(UNII: 50C1307PZG)
Olea Europaea Leaf(UNII: MJ95C3OH47)
Olive Oil(UNII: 6UYK2W1W1E)
Magnolia Obovata Bark(UNII: SM9Z2LD5TK)
Aluminum Hydroxide(UNII: 5QB0T2IUN0)
Zirconium Oxide(UNII: S38N85C5G0)
Phenoxyethanol(UNII: HIE492ZZ3T)
Aloe Vera Leaf(UNII: ZY81Z83H0X)
Pentasodium Pentetate(UNII: 961TOZ5L7T)
Tricalcium Phosphate(UNII: K4C08XP666)
Citric Acid Monohydrate(UNII: 2968PHW8QP)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Silver(UNII: 3M4G523W1G)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63433-451-5130 g in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product05/01/2005
2NDC:63433-451-791.5 g in 1 CELLO PACK Type 0: Not a Combination Product05/01/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 05/01/2005 12/26/2018

PRINCIPAL DISPLAY PANEL

DHC

White
Sunscreen

SPF 25

1 fl. oz. (30 ml)

Principal Display Panel - 30 ml Carton