NDC Code(s) : 10210-0007-0
Packager : Carma Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CARMEX moisture Plus Ultra Hydrating Lip Balm Broad Spectrum SPF 15 Sunscreen AVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE SALVE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10210-0007
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE2.5 g in 100 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE3.3 g in 100 g
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE5.5 g in 100 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE4.4 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF(UNII: ZY81Z83H0X)
YELLOW WAX(UNII: 2ZA36H0S2V)
SHEA BUTTER(UNII: K49155WL9Y)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS(UNII: 137SL7IL0Y)
CAMPHOR (NATURAL)(UNII: N20HL7Q941)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
SAFFLOWER SEED(UNII: 8FCL6A31TX)
COCONUT OIL(UNII: Q9L0O73W7L)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
CANDELILLA WAX(UNII: WL0328HX19)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
MEADOWFOAM SEED OIL(UNII: 412ZHA4T4Y)
MENTHOL(UNII: L7T10EIP3A)
OLIVE OIL(UNII: 6UYK2W1W1E)
CERESIN(UNII: Q1LS2UJO3A)
PALMITOYL OLIGOPEPTIDE(UNII: HO4ZT5S86C)
HYDROGENATED AVOCADO OIL(UNII: JA69U4B4XI)
PETROLATUM(UNII: 4T6H12BN9U)
PHENOL(UNII: 339NCG44TV)
PPG-3 BENZYL ETHER MYRISTATE(UNII: 8075L58MKO)
RICINUS COMMUNIS SEED(UNII: 7EK4SFN1TX)
SACCHARIN(UNII: FST467XS7D)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10210-0007-02 g in 1 CYLINDER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/02/2013

PRINCIPAL DISPLAY PANEL

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