NDC Code(s) : 43419-310-14, 43419-310-28, 43419-310-29, 43419-310-30
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AMOREPACIFIC OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-310
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.07 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.19 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC - UNII:J41CSQ7QDS) 		ZINC OXIDE0.00025 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-310-145 mL in 1 TUBE
2NDC:43419-310-2860 mL in 1 TUBE
3NDC:43419-310-2915 mL in 1 TUBE
4NDC:43419-310-301 mL in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/15/2010

PRINCIPAL DISPLAY PANEL

AMOREPACIFIC

NATURAL PROTECTOR
SPF 30/PA+++

PRINCIPAL DISPLAY PANEL - 60 ml Carton