TRUAGE LIP BALM POMEGRANATE MINT SPF15- avobenzone, ocitnoxate, octocrylene, oxybenzone lipstick

TruAge Lip Balm Pomegranate Mint by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Avobenzone  3%

Octinoxate  7.5%

Octocrylene 2.5%

Oxybenzone 4%

INDICATIONS & USAGE

Helps protect against sunburn and chapped lips

Other Ingredients

Camphor, Carnosine, Cornus Officinalis Fruit Extract, Diethylhexyl Carbonate, Euphorbia Cerifera (Candelilla) Wax, Flavor, Glycerin, Hydrogenated Castor Oil, Macadamia Ternifolia Seed Oil, Menthol, Morinda Citrifolia 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 Extract, Tocopheryl Acetate, Vaccinium Corymbosum (Blueberry) Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Water

WARNINGS

Do not used on damaged or broken skin.   Do not use if cap is not sealed.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TRUAGE LIP BALM POMEGRANATE MINT  SPF15
avobenzone, ocitnoxate, octocrylene, oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14743-337
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CARNOSINE (UNII: 8HO6PVN24W)
CORNUS OFFICINALIS FRUIT (UNII: 23NL8NQ187)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 HYDROGENATED CASTOR OIL (UNII: MH590ECD4O)
MACADAMIA OIL (UNII: 515610SU8C)
MENTHOL (UNII: L7T10EIP3A)
MORINDA CITRIFOLIA SEED OIL (UNII: 84J6H9QZUA)
NONI FRUIT JUICE (UNII: 6ULF85Z07J)
OLEA EUROPAEA FLOWER (UNII: 498M34P1VZ)
CERESIN (UNII: Q1LS2UJO3A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)
PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VACCINIUM CORYMBOSUM WHOLE (UNII: G1DGA0BS6T)
VACCINIUM MACROCARPON WHOLE (UNII: D11KO7O2DX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14743-337-01	4.6 g in 1 CYLINDER; Type 0: Not a Combination Product	12/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/01/2016

Labeler - Tahitian Noni International (609927905)