NDC Code(s) : 63433-222-07, 63433-222-85
Packager : DHC USA Incorporated

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DHC Camu Camu White Day MilkOctinoxate and Oxybenzone LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63433-222
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate35 mg in 0.5 mL
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone5 mg in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Butylene Glycol(UNII: 3XUS85K0RA)
Cyclomethicone 5(UNII: 0THT5PCI0R)
Triethylhexanoin(UNII: 7K3W1BIU6K)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Titanium Dioxide(UNII: 15FIX9V2JP)
Mica(UNII: V8A1AW0880)
Glycerin(UNII: PDC6A3C0OX)
Polysorbate 80(UNII: 6OZP39ZG8H)
Trilaureth-4 Phosphate(UNII: M96W2OLL2V)
Carbomer Interpolymer Type A (55000 MPA.S)(UNII: 59TL3WG5CO)
Phenoxyethanol(UNII: HIE492ZZ3T)
Meadowfoam Seed Oil(UNII: 412ZHA4T4Y)
Dimethicone(UNII: 92RU3N3Y1O)
Allantoin(UNII: 344S277G0Z)
Trolamine(UNII: 9O3K93S3TK)
Edetate Disodium(UNII: 7FLD91C86K)
Disodium Stearoyl Glutamate(UNII: 45ASM2L11M)
Aluminum Hydroxide(UNII: 5QB0T2IUN0)
Myrciaria Dubia Fruit(UNII: YSW4EM1EKP)
Myrciaria Dubia Seed(UNII: C3JGA8OR9K)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63433-222-0747 mL in 1 BOTTLE, PUMP
2NDC:63433-222-850.3 mL in 1 CELLO PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 04/01/2012

PRINCIPAL DISPLAY PANEL

Camu-Camu
White Day Milk
with sunscreen

SPF 20

DHC

1.6 fl. oz. U.S. (50 ml)

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton