NDC Code(s) : 71014-008-01
Packager : Eai-jr 286, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Beeswax Lip Balm SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71014-008
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 g
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE7.5 g in 100 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE2.5 g in 100 g
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE6 g in 100 g
Inactive Ingredients
Ingredient Name Strength
SUNFLOWER OIL(UNII: 3W1JG795YI)
YELLOW WAX(UNII: 2ZA36H0S2V)
OLIVE OIL(UNII: 6UYK2W1W1E)
CANNABIS SATIVA SEED OIL(UNII: 69VJ1LPN1S)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71014-008-014 g in 1 CYLINDER Type 0: Not a Combination Product22/11/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 11/22/2016

PRINCIPAL DISPLAY PANEL

Vertra Elemental Resistance

Lip Balm Borad Spectrum SPF 30+

Beeswax Lip Balm

Net Wt. .15oz.

Label