NDC Code(s) : 69533-115-01, 69533-115-02
Packager : aromatica co.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NATURAL TINTED SUN SPF30TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69533-115
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 DIOXIDE5.85 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
OCTYLDODECANOL(UNII: 461N1O614Y)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROGENATED JOJOBA OIL, RANDOMIZED(UNII: Q47ST02F58)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
PROPANEDIOL(UNII: 5965N8W85T)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP(UNII: 9YT4B71U8P)
ROSA X DAMASCENA FLOWER(UNII: JWB78P295A)
STEARALKONIUM HECTORITE(UNII: OLX698AH5P)
PROPYLENE CARBONATE(UNII: 8D08K3S51E)
GLYCERIN(UNII: PDC6A3C0OX)
ZANTHOXYLUM PIPERITUM FRUIT PULP(UNII: 7PFC2VA251)
USNEA BARBATA(UNII: D6DVA9TCAP)
ANEMONE CERNUA ROOT(UNII: FY35I16MPL)
ARGAN OIL(UNII: 4V59G5UW9X)
SORBITAN OLIVATE(UNII: MDL271E3GR)
FERRIC OXIDE RED(UNII: 1K09F3G675)
BETASIZOFIRAN(UNII: 2X51AD1X3T)
TOCOPHEROL(UNII: R0ZB2556P8)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SUNFLOWER OIL(UNII: 3W1JG795YI)
LIME OIL(UNII: UZH29XGA8G)
CEDRUS ATLANTICA WOOD OIL(UNII: JEX140NPX8)
CITRUS X LIMON FRUIT OIL(UNII: 0HNC1J1YED)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69533-115-021 in 1 PACKAGE 04/01/2017
1NDC:69533-115-0150 mL in 1 CONTAINER 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 04/01/2017

PRINCIPAL DISPLAY PANEL

SUN CREAM