FDA.reportPublic FDA data

MINI BERRY LIP BALM BLUEBERRY

Manufacturer
TONYMOLY CO., LTD. | COSMAX INC.
Effective date
2015-03-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:41:52

Label at a glance#

ProductMINI BERRY LIP BALM BLUEBERRY
Active ingredientOCTINOXATE, Titanium Dioxide
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Ethylhexyl Methoxycinnamate 5.00%, Titanium Dioxide 0.23%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients: Polyglyceryl-2 Triisostearate, Petrolatum, Diisostearyl Malate, Bis-Diglyceryl Polyacyladipate-2, Polybutene, Benzophenone-3, Hydroxystearic Acid, Microcrystalline Wax, Silica Dimethyl Silylate, VP/Hexadecene Copolymer, Mica (CI 77019), Sorbitan Isostearate, Red 28 Lake (CI 45410), Fragrance(Parfum), Butylparaben, Tocopheryl Acetate, Methicone, Polyglyceryl-2 Diisostearate, Red 6 (CI 15850), Yellow 5 Lake (CI 19140), Vaccinium Angustifolium (Blueberry) Fruit Extract, Water, Butylene Glycol, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Phenoxyethanol, Methylparaben, Ethylparaben, Isobutylparaben, Propylparaben

PURPOSE

OTC - PURPOSE SECTION

PURPOSE: Sunscreen

WARNINGS

WARNINGS SECTION

Warnings: 1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children: Keep out of reach of babies and children

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

INDICATIONS AND USAGE: Apply on lip with fingers

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

DOSAGE AND ADMINISTRATION: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

Image of cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138806358537586GTIN-13: 8806358537586
EAN-13: 8806358537586
GTIN storage (14 digits): 08806358537586		mini berry lip balm blueberry carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59078-038-012020-01-31C16284748780-19d75b9d0-de2b-f424-e053-dadaa90a57ce13c6e626-c1ac-4710-8ddb-b52fa1c23dc1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59078-038-01MINI BERRY LIP BALM BLUEBERRY7.2 g in 1 CARTONCREAM7.22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59078-038MINI BERRY LIP BALM BLUEBERRY (OCTINOXATE, TITANIUM DIOXIDE) CREAM [TONYMOLY CO., LTD.]2Legacy NDC, 1 package rows20150304_13c6e626-c1ac-4710-8ddb-b52fa1c23dc1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP2
Diisostearyl MalateINACTIVE INGREDIENTQBS8A3XZGQ2
PetrolatumINACTIVE INGREDIENT4T6H12BN9U2

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59078-03859078-038-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
Titanium Dioxide15FIX9V2JPACTIB
Petrolatum4T6H12BN9UIACT
Diisostearyl MalateQBS8A3XZGQIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL5850 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / TOPICAL11460 mgExact identifier — unii candidate
18 equally ranked IID candidates

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
7ea7cc72-29ec-4e7d-9cd4-8c69e9829ead13c6e626-c1ac-4710-8ddb-b52fa1c23dc12015-03-04WarningsExact identifier
spl id: 7ea7cc72-29ec-4e7d-9cd4-8c69e9829ead
spl set id: 13c6e626-c1ac-4710-8ddb-b52fa1c23dc1

Reported adverse events (FAERS/openFDA)#

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