Dr C Tuna Sun protector lip balm SPF 15

Manufacturer
Farmasi US LLC
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:08

Label at a glance#

ProductDr C Tuna Sun protector lip balm SPF 15
Active ingredientHOMOSALATE, OCTINOXATE
Label structure8 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply liberally 15 minutes before sun exposure - reapply at least every two hours. Apply morning and night, and as often as needed during the day. Reapply frequently on sun-centric days and adventures. Children under 6 months of age: Ask a doctor. Sun Protection Measures:

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Homosalate 4,45 %

Ethylhexyl Methoxycinnamate 3,45 %

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

Warnings:

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask doctor 

OTC - STOP USE SECTION

if rash occurs.

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. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure - reapply at least every two hours. Apply morning and night, and as often as needed during the day. Reapply frequently on sun-centric days and adventures. Children under 6 months of age: Ask a doctor. Sun Protection Measures:

Other information:

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Polyisoprene, C18-70 Isoalkane, Caprylic/Capric Triglyceride, Olus Oil, Synthetic Beeswax, Ceresin, Cetyl Alcohol, Di-C12-15 Alkyl Fumarate, Butyrospermum Parkii Butter, Silica, Aroma/Flavour, Tocopheryl Acetate.

Questions or Comments?

OTC - QUESTIONS SECTION

info@farmasius.com (833) 432-7627

Monday-Friday (9 a.m.-9 p.m. EST)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74690-020-00Dr C Tuna Sun protector lip balm SPF 151 in 1 BOXCREAM12
74690-020-00Dr C Tuna Sun protector lip balm SPF 1515 mL in 1 BOTTLECREAM152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74690-020DR C TUNA SUN PROTECTOR LIP BALM SPF 15 (HOMOSALATE, OCTINOXATE) CREAM [FARMASI US LLC]2Current NDC, Legacy NDC, 2 package rows20231106_ddcd82b5-9ad2-2340-e053-2a95a90a4fc0.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74690-02074690-020-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
Dr C Tuna Sun protector lip balm SPF 15HOMOSALATE, OCTINOXATEFarmasi US LLCddcd82b5-9ad2-2340-e053-2a95a90a4fc02023-11-05WarningsExact identifier
ndc (package): 74690-020-00
ndc (product): 74690-020
ndc11 (package): 74690002000
spl id: 097353b6-41e6-cea1-e063-6294a90aea19
spl set id: ddcd82b5-9ad2-2340-e053-2a95a90a4fc0

Reported adverse events (FAERS/openFDA)#

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