NDC Code(s) : 70581-019-00
Packager : BPS 60

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

10 Armani Prima Control Glow Moisturizer SBS SPF 35OCTINOXATE, TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70581-019
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE50 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE19 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
GLYCERIN(UNII: PDC6A3C0OX)
ALCOHOL(UNII: 3K9958V90M)
ISODODECANE(UNII: A8289P68Y2)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
BETAINE(UNII: 3SCV180C9W)
TALC(UNII: 7SEV7J4R1U)
DIISOSTEARYL MALATE(UNII: QBS8A3XZGQ)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
MACADAMIA OIL(UNII: 515610SU8C)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ADENOSINE(UNII: K72T3FS567)
MAGNESIUM SULFATE, UNSPECIFIED FORM(UNII: DE08037SAB)
MAGNESIUM ASPARTATE(UNII: R17X820ROL)
ETHYLHEXYL HYDROXYSTEARATE(UNII: B7I80BVV5E)
ETHYL MENTHANE CARBOXAMIDE(UNII: 6S7S02945H)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
JOJOBA OIL(UNII: 724GKU717M)
LIMONENE, (+)-(UNII: GFD7C86Q1W)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
LINALOOL, (+/-)-(UNII: D81QY6I88E)
BENZYL ALCOHOL(UNII: LKG8494WBH)
COPPER GLUCONATE(UNII: RV823G6G67)
CORIANDER OIL(UNII: 7626GC95E5)
MORINGA OLEIFERA SEED(UNII: TIX5482832)
PASSIFLORA EDULIS SEED OIL(UNII: F3VOA31UHQ)
DISODIUM STEAROYL GLUTAMATE(UNII: 45ASM2L11M)
METHICONE (20 CST)(UNII: 6777U11MKT)
APRICOT KERNEL OIL(UNII: 54JB35T06A)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
ALUMINUM OXIDE(UNII: LMI26O6933)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70581-019-001 in 1 BOX 01/01/2018
130 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 Drug M020 01/01/2018

LABELER - BPS 60(272259304)

PRINCIPAL DISPLAY PANEL

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