NDC Code(s) : 43479-206-12, 43479-206-52
Packager : KATE SOMERVILLE SKINCARE, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PRIME PROTECTION AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43479-206
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE3 g in 100 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE10 g in 100 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE7.5 g in 100 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE2.87 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ISODECYL NEOPENTANOATE(UNII: W60VYE24XC)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER(UNII: O4I3UFO6ZF)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
C12-15 ALKYL BENZOATE(UNII: A9EJ3J61HQ)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER(UNII: KFR5QEN0N9)
POLYSILICONE-15(UNII: F8DRP5BB29)
POLYESTER-7(UNII: 0841698D2F)
NEOPENTYL GLYCOL DIHEPTANOATE(UNII: 5LKW3C543X)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
PPG-15 STEARYL ETHER(UNII: 1II18XLS1L)
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
UREA(UNII: 8W8T17847W)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
LENTINULA EDODES WHOLE(UNII: NW7F4358J8)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
TREHALOSE(UNII: B8WCK70T7I)
CARBOMER 940(UNII: 4Q93RCW27E)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
POLYSORBATE 20(UNII: 7T1F30V5YH)
PALMITOYL TRIPEPTIDE-1(UNII: RV743D216M)
PALMITOYL TETRAPEPTIDE-7(UNII: Q41S464P1R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43479-206-521 in 1 BOX
1NDC:43479-206-1230 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 final part352 06/22/2014

PRINCIPAL DISPLAY PANEL

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