NDC Code(s) : 69533-116-01, 69533-116-02
Packager : aromatica co.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CALENDULA NON-NANO UV PROTECTION UNSCENTED SPF30Zinc Oxide,Titanium Dioxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69533-116
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION12.6 g in 70 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.806 g in 70 g
Inactive Ingredients
Ingredient Name Strength
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
COCONUT OIL(UNII: Q9L0O73W7L)
COCO-CAPRYLATE/CAPRATE(UNII: 8D9H4QU99H)
GLYCERIN(UNII: PDC6A3C0OX)
POLYGLYCERYL-4 ISOSTEARATE(UNII: 820DPX33S7)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
ISOAMYL LAURATE(UNII: M1SLX00M3M)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
OCTYLDODECANOL(UNII: 461N1O614Y)
NIACINAMIDE(UNII: 25X51I8RD4)
BABASSU OIL(UNII: 8QSB4M5477)
SHEANUT(UNII: 84H6HBP32L)
MEADOWFOAM SEED OIL(UNII: 412ZHA4T4Y)
SORBITAN OLIVATE(UNII: MDL271E3GR)
STEARIC ACID(UNII: 4ELV7Z65AP)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
JOJOBA OIL(UNII: 724GKU717M)
VERBENA OFFICINALIS(UNII: QT8A71T9BM)
ROSEMARY(UNII: IJ67X351P9)
PROPANEDIOL(UNII: 5965N8W85T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
XANTHAN GUM(UNII: TTV12P4NEE)
ADENOSINE(UNII: K72T3FS567)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69533-116-021 in 1 PACKAGE 28/03/2017
1NDC:69533-116-0170 g 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 03/28/2017

PRINCIPAL DISPLAY PANEL

CALENDULA