TRUAGE AGE THERAPY LIP BALM SPF15- octinoxate, octocrylene, oxybenzone, avobenzone stick

TruAge AGE Therapy Lip Balm by

Drug Labeling and Warnings

TruAge AGE Therapy Lip Balm by is a Otc medication manufactured, distributed, or labeled by Tahitian Noni International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate: 7.5%

Oxybenzone 4%

Avobenzone 3%

Octocrylene 2.5%

Other Ingredients

Camphor, Carnosine, Cornus Officinalis (Dogwood) Fruit Extract, Diethylhexyl Carbonate, Euphorbia Cerifera (Candelilla) Wax, Flavor, Glycerin,
Hydrogenated Castor Oil, Macadamia Ternifolia (Macadamia) Seed Oil, Menthol, Morinda Citrifolia (Noni) Fruit Juice, Morinda Citrifolia L. (Noni) Seed Oil, Olea Europaea (Olive) Leaf Extract, Ozokerite, Phenoxyethanol, Ricinus Communis (Castor) Seed Oil, Sorbitan Oleate, Stevia Rebaudiana Leaf/Stem Powder, Tocopheryl Acetate, Vaccinium Corymbosum (Blueberry) Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract,
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRUAGE AGE THERAPY LIP BALM  SPF15
octinoxate, octocrylene, oxybenzone, avobenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14743-285
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CARNOSINE (UNII: 8HO6PVN24W)
CORNUS OFFICINALIS WHOLE (UNII: CXC44F678T)
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
MACADAMIA SEED OIL GLYCERETH-8 ESTERS (UNII: C6734SM77O)
MENTHOL (UNII: L7T10EIP3A)
MORINDA CITRIFOLIA WHOLE (UNII: 241SVD3S13)
MORINDA CITRIFOLIA SEED OIL (UNII: 84J6H9QZUA)
OLEA EUROPAEA WHOLE (UNII: 769297N5OK)
CERESIN (UNII: Q1LS2UJO3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
SORBITAN DIOLEATE (UNII: 6T6N9I9VD0)
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BLUEBERRY (UNII: 253RUG1X1A)
CRANBERRY (UNII: 0MVO31Q3QS)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14743-285-01	4.8 g in 1 CYLINDER; Type 0: Not a Combination Product	04/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2016

Labeler - Tahitian Noni International (609927905)