NDC Code(s) : 69533-101-01, 69533-101-02
Packager : aromatica co.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Natural Tinted Sun-creamTitanium Dioxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69533-101
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 Dioxide0.1175 1 in 50 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
octyldodecanol(UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
propanediol(UNII: 5965N8W85T)
GLYCERYL OLEATE(UNII: 4PC054V79P)
JOJOBA OIL, RANDOMIZED(UNII: 7F0EV20QYL)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
GLYCERIN(UNII: PDC6A3C0OX)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP(UNII: 9YT4B71U8P)
ROSA DAMASCENA FLOWER(UNII: JWB78P295A)
STEARALKONIUM HECTORITE(UNII: OLX698AH5P)
PROPYLENE CARBONATE(UNII: 8D08K3S51E)
argan oil(UNII: 4V59G5UW9X)
ZANTHOXYLUM PIPERITUM FRUIT PULP(UNII: 7PFC2VA251)
USNEA BARBATA(UNII: D6DVA9TCAP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
APRICOT KERNEL OIL(UNII: 54JB35T06A)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SUNFLOWER OIL(UNII: 3W1JG795YI)
ORANGE OIL(UNII: AKN3KSD11B)
lime oil(UNII: UZH29XGA8G)
CEDRUS ATLANTICA BARK OIL(UNII: ZX5QRE4U60)
CITRUS LIMON FRUIT OIL(UNII: 0HNC1J1YED)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69533-101-021 in 1 BOX
1NDC:69533-101-0150 mL in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/21/2015

PRINCIPAL DISPLAY PANEL

tintedsuncream