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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TruAge Age Therapy Original Lip Balm SPF 15

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

TruageLip balm

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2016	01/31/2022

Labeler - Tahitian Noni International (609927905)

Revised: 12/2021

Document Id: df49cb70-74b7-4dc4-a809-94a8a810ed8f

Set id: eabfb658-63a3-4810-90df-659dd4df7bdd

Version: 10

Effective Time: 20211210

Tahitian Noni International