Zinka Passion Fruit SPF 15 Lip Balm

Manufacturer
Zinka | OraLabs
Effective date
2014-05-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:39:15

Label at a glance#

ProductZinka Passion Fruit SPF 15 Lip Balm
Active ingredientOCTINOXATE, OXYBENZONE, PETROLATUM
Label structure8 sections

Indications and uses

Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.

Dosage and administration

Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate (7.5%), Oxybenzone (3.5%)

Petrolatum (42%)

Purpose

OTC - PURPOSE SECTION

Sunscreen, Sunscreen, Skin Protectant

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ozokerite, Mineral Oil, PEG-8, Lanolin, Microcrystalline Wax, Flavor, Paraffin Wax, Copernicia Cerifera (Carnauba) Wax, Sucralose, Aloe Barbadenis Leaf Extract, Tocopherol, Methylparaben, Propylparaben.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zinka Passion Fruit Label SPF 15 Lip Balm
Zinka Passion Fruit Label SPF 15 Lip Balm

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52993-111-022020-01-31C16284748780-19d75b9cf-f803-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52993-111-02Zinka Passion Fruit SPF 15 Lip Balm1 g in 1 CONTAINERSTICK11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52993-111ZINKA PASSION FRUIT SPF 15 LIP BALM (OXYBENZONE, OCTINOXATE, PETROLATUM) STICK [ZINKA]1Legacy NDC, 1 package rows20140511_662cac4f-c42b-4ec5-b8da-7a0819e481db.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
PETROLATUMACTIVE MOIETY4T6H12BN9U1
CERESININACTIVE INGREDIENTQ1LS2UJO3A1
LANOLININACTIVE INGREDIENT7EV65EAW6H1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVP1
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KY1
PEG-8 STEARATEINACTIVE INGREDIENT2P9L47VI5E1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52993-11152993-111-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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 · 38 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii candidate
19 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / RECTAL105 mgExact identifier — unii candidate
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPLOTION / TOPICAL48000 mgExact identifier — unii candidate
19 equally ranked IID candidates
MICROCRYSTALLINE WAXMICROCRYSTALLINE WAXXOF597Q3KYOINTMENT / TOPICAL3575 mgExact identifier — unii candidate
4 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPFILM, EXTENDED RELEASE / TRANSDERMAL162 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii candidate
19 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HLOTION / TOPICAL1.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPSUPPOSITORY / VAGINAL1464.9 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, FILM COATED / ORAL2.49 mgExact identifier — unii candidate
19 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PEG-8 STEARATEPEG-8 MONOSTEARATE2P9L47VI5ECONCENTRATE / ORAL25 mg/5mlExact identifier — unii candidate
4 equally ranked IID candidates
PEG-8 STEARATEPEG-8 MONOSTEARATE2P9L47VI5ECREAM / TOPICAL229 mgExact identifier — unii candidate
4 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPGEL / TOPICAL20 mgExact identifier — unii candidate
19 equally ranked IID candidates
CERESINCERESINQ1LS2UJO3ACREAM / VAGINAL280 mgExact identifier — unii candidate
2 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM, AUGMENTED / TOPICAL25 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPSYSTEM / TRANSDERMAL170 mgExact identifier — unii candidate
19 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSPRAY / NASALNAExact identifier — unii candidate
9 equally ranked IID candidates
MICROCRYSTALLINE WAXMICROCRYSTALLINE WAXXOF597Q3KYGEL / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSHAMPOO / TOPICAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
MICROCRYSTALLINE WAXMICROCRYSTALLINE WAXXOF597Q3KYCREAM / VAGINAL23 mgExact identifier — unii candidate
4 equally ranked IID candidates
PEG-8 STEARATEPEG-8 MONOSTEARATE2P9L47VI5ESPONGE / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPAEROSOL, FOAM / TOPICAL240 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOIL / AURICULAR (OTIC)419 mgExact identifier — unii candidate
19 equally ranked IID candidates
CERESINCERESINQ1LS2UJO3AOINTMENT / TOPICAL1097 mgExact identifier — unii candidate
2 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPEMULSION / TOPICAL68100 mgExact identifier — unii candidate
19 equally ranked IID candidates
PEG-8 STEARATEPEG-8 MONOSTEARATE2P9L47VI5ESUSPENSION / ORAL60 mgExact identifier — unii candidate
4 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPPASTE / DENTAL687 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCAPSULE / ORAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, COATED / ORAL4.8 mgExact identifier — unii candidate
19 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / VAGINAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
MICROCRYSTALLINE WAXMICROCRYSTALLINE WAXXOF597Q3KYCAPSULE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
4 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOIL / TOPICAL2509 mgExact identifier — unii candidate
19 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HEMULSION / TOPICAL0.25 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / OPHTHALMIC3 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPPASTILLE / ORAL3.6 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET / ORAL7.5 mgExact identifier — unii candidate
19 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii candidate
9 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
662cac4f-c42b-4ec5-b8da-7a0819e481db662cac4f-c42b-4ec5-b8da-7a0819e481db2014-05-09WarningsExact identifier
spl id: 662cac4f-c42b-4ec5-b8da-7a0819e481db
spl set id: 662cac4f-c42b-4ec5-b8da-7a0819e481db

Reported adverse events (FAERS/openFDA)#

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