NDC Code(s) : 69533-113-01, 69533-113-02
Packager : aromatica co.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NATURAL TINTED SUN COVER CUSHION - NATURAL BEIGETitanium Dioxide LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69533-113
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 Dioxide1.98 g in 17 g
Inactive Ingredients
Ingredient Name Strength
ALTHAEA OFFICINALIS ROOT(UNII: TRW2FUF47H)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HYDROGENATED JOJOBA OIL, RANDOMIZED(UNII: Q47ST02F58)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
NIACINAMIDE(UNII: 25X51I8RD4)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
OCTYLDODECANOL(UNII: 461N1O614Y)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
STEARALKONIUM HECTORITE(UNII: OLX698AH5P)
PROPYLENE CARBONATE(UNII: 8D08K3S51E)
SORBITAN OLIVATE(UNII: MDL271E3GR)
MICA(UNII: V8A1AW0880)
ARGAN OIL(UNII: 4V59G5UW9X)
VERBENA OFFICINALIS(UNII: QT8A71T9BM)
ROSEMARY(UNII: IJ67X351P9)
PROPANEDIOL(UNII: 5965N8W85T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
FERRIC OXIDE RED(UNII: 1K09F3G675)
MEADOWFOAM SEED OIL(UNII: 412ZHA4T4Y)
BETASIZOFIRAN(UNII: 2X51AD1X3T)
ADENOSINE(UNII: K72T3FS567)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69533-113-021 in 1 PACKAGE 09/02/2016
1NDC:69533-113-0117 g 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 09/02/2016

PRINCIPAL DISPLAY PANEL

sun cover cushion natural beige