NDC Code(s) : 69842-034-01
Packager : CVS

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LIP BALM SPF30 Avobenzone 2.00% Homosalate 15.00% Octisalate 5.00% Octinoxate 7.50% STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69842-034
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		Avobenzone2 g in 100 g
Homosalate(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		Homosalate15 g in 100 g
Octisalate(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		Octisalate5 g in 100 g
Octinoxate(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		Octinoxate7.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
Ascorbyl Palmitate(UNII: QN83US2B0N)
YELLOW WAX(UNII: 2ZA36H0S2V)
Benzyl Alcohol(UNII: LKG8494WBH)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
Candelilla Wax(UNII: WL0328HX19)
Ethylhexyl Palmitate(UNII: 2865993309)
SUNFLOWER OIL(UNII: 3W1JG795YI)
AVOCADO OIL(UNII: 6VNO72PFC1)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)(UNII: T9296U138P)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
CASTOR OIL(UNII: D5340Y2I9G)
JOJOBA OIL(UNII: 724GKU717M)
Saccharin(UNII: FST467XS7D)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69842-034-011 in 1 CARTON 17/02/2014
14 g in 1 CONTAINER 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 02/17/2014

PRINCIPAL DISPLAY PANEL

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