NDC Code(s) : 10742-8692-1, 10742-8689-1
Packager : The Mentholatum Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Softlips Cube Chocolate Mintdimethicone, octinoxate, oxybenzone OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10742-8692
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE20 mg in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE75 mg in 1 g
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE30 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CERESIN(UNII: Q1LS2UJO3A)
PETROLATUM(UNII: 4T6H12BN9U)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
OCTYLDODECANOL(UNII: 461N1O614Y)
MYRISTYL MYRISTATE(UNII: 4042ZC00DY)
MYRISTYL LACTATE(UNII: 1D822OC34X)
SQUALANE(UNII: GW89575KF9)
CETYL ALCOHOL(UNII: 936JST6JCN)
SHEA BUTTER(UNII: K49155WL9Y)
MYRISTYL LAURATE(UNII: 58U0NZN2BT)
MYRISTYL ALCOHOL(UNII: V42034O9PU)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
SUNFLOWER OIL(UNII: 3W1JG795YI)
LINOLEIC ACID(UNII: 9KJL21T0QJ)
LINOLENIC ACID(UNII: 0RBV727H71)
MENTHOL, UNSPECIFIED FORM(UNII: L7T10EIP3A)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE(UNII: VLW429K27K)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
TETRAHEXYLDECYL ASCORBATE(UNII: 9LBV3F07AZ)
TOCOPHEROL(UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10742-8692-11 in 1 BLISTER PACK 11/01/2016
16.5 g in 1 JAR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/01/2016 09/12/2018
Softlips Cube Salted Carameldimethicone, octinoxate, oxybenzone OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10742-8689
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE20 mg in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE75 mg in 1 g
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE30 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CERESIN(UNII: Q1LS2UJO3A)
PETROLATUM(UNII: 4T6H12BN9U)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
OCTYLDODECANOL(UNII: 461N1O614Y)
MYRISTYL MYRISTATE(UNII: 4042ZC00DY)
MYRISTYL LACTATE(UNII: 1D822OC34X)
SQUALANE(UNII: GW89575KF9)
CETYL ALCOHOL(UNII: 936JST6JCN)
SHEA BUTTER(UNII: K49155WL9Y)
MYRISTYL LAURATE(UNII: 58U0NZN2BT)
MYRISTYL ALCOHOL(UNII: V42034O9PU)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
SUNFLOWER OIL(UNII: 3W1JG795YI)
LINOLEIC ACID(UNII: 9KJL21T0QJ)
LINOLENIC ACID(UNII: 0RBV727H71)
MENTHOL, UNSPECIFIED FORM(UNII: L7T10EIP3A)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE(UNII: VLW429K27K)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
TETRAHEXYLDECYL ASCORBATE(UNII: 9LBV3F07AZ)
TOCOPHEROL(UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10742-8689-11 in 1 BLISTER PACK 11/01/2016
16.5 g in 1 JAR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/01/2016 09/29/2017

PRINCIPAL DISPLAY PANEL

Softlips Cube Chocolate Mint, Salted Caramel

PRINCIPAL DISPLAY PANEL

Drug Facts