NDC Code 43419-310-29 | pharmacompass.com

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

AMOREPACIFIC OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE(UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.19 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z) (ZINC - UNII:J41CSQ7QDS)	ZINC OXIDE	0.00025 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE(UNII: NMQ347994Z)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
POLYSORBATE 60(UNII: CAL22UVI4M)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
POLYOXYL 40 STEARATE(UNII: 13A4J4NH9I)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CARROT(UNII: L56Z1JK48B)
SOYBEAN(UNII: L7HT8F1ZOD)
ASIAN GINSENG(UNII: CUQ3A77YXI)
NYMPHAEA ALBA FLOWER(UNII: 40KQ7Q535O)
BAMBUSA VULGARIS SAP(UNII: 26W4035XBO)
PEG-100 STEARATE(UNII: YD01N1999R)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
ALUMINUM STEARATE(UNII: U6XF9NP8HM)
ALUMINUM OXIDE(UNII: LMI26O6933)
STEARIC ACID(UNII: 4ELV7Z65AP)
ETHOHEXADIOL(UNII: M9JGK7U88V)
EDETATE DISODIUM(UNII: 7FLD91C86K)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
POLYSORBATE 20(UNII: 7T1F30V5YH)
METHYLPARABEN(UNII: A2I8C7HI9T)

#	Item Code	Package Description
Packaging
1	NDC:43419-310-14	5 mL in 1 TUBE
2	NDC:43419-310-28	60 mL in 1 TUBE
3	NDC:43419-310-29	15 mL in 1 TUBE
4	NDC:43419-310-30	1 mL in 1 PACKET

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	09/15/2010

NDC 43419-310-29
API & Excipient Details