FDA.reportPublic FDA data

TruAge Lip Balm Pomegranate Mint

Manufacturer
Tahitian Noni International
Effective date
2020-12-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:34:48

Label at a glance#

ProductTruAge Lip Balm Pomegranate Mint SPF15
Active ingredientAvobenzone, Octinoxate, OCTOCRYLENE, OXYBENZONE
Label structure5 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone  3%

Octinoxate  7.5%

Octocrylene 2.5%

Oxybenzone 4%

OTC - PURPOSE SECTION

INDICATIONS & USAGE SECTION

Helps protect against sunburn and chapped lips

Other Ingredients

INACTIVE INGREDIENT SECTION

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 SECTION

OTC - DO NOT USE SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PomegranatePomegranate

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14743-337-012022-01-28C16284748780-1d6a99b39-b49e-a426-e053-dadaa90af4c2A.G.E. Therapy Lip Balm SPF 15 Pomegranate Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14743-337-01TruAge Lip Balm Pomegranate MintSPF154.6 g in 1 CYLINDERLIPSTICK4.67

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14743-337TRUAGE LIP BALM POMEGRANATE MINT SPF15 (AVOBENZONE, OCITNOXATE, OCTOCRYLENE, OXYBENZONE) LIPSTICK [TAHITIAN NONI INTERNATIONAL]7Legacy NDC, 1 package rows20201209_e2a184ef-6815-441f-9c11-044e91f10d63.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14743-33714743-337-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
Octinoxate4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
CAMPHOR (NATURAL)N20HL7Q941IACT
CARNOSINE8HO6PVN24WIACT
CORNUS OFFICINALIS FRUIT23NL8NQ187IACT
CANDELILLA WAXWL0328HX19IACT
GLYCERINPDC6A3C0OXIACT
PEG-10 HYDROGENATED CASTOR OILMH590ECD4OIACT
MACADAMIA OIL515610SU8CIACT
MENTHOLL7T10EIP3AIACT
MORINDA CITRIFOLIA SEED OIL84J6H9QZUAIACT
NONI FRUIT JUICE6ULF85Z07JIACT
OLEA EUROPAEA FLOWER498M34P1VZIACT
CERESINQ1LS2UJO3AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
RICINUS COMMUNIS SEED7EK4SFN1TXIACT
PEG-6 SORBITAN OLEATE58O7V09UCIIACT
STEVIA REBAUDIANA WHOLE6U422Y08O2IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VACCINIUM CORYMBOSUM WHOLEG1DGA0BS6TIACT
VACCINIUM MACROCARPON WHOLED11KO7O2DXIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5b6d0007-869d-4f52-a39e-7ac681c294fee2a184ef-6815-441f-9c11-044e91f10d632020-12-08WarningsExact identifier
spl id: 5b6d0007-869d-4f52-a39e-7ac681c294fe
spl set id: e2a184ef-6815-441f-9c11-044e91f10d63

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.