FDA.reportPublic FDA data

Carmex Classic Lip Balm Medicated SPF15 Triple Force Formula

Manufacturer
Carma Laboratories, Inc.
Effective date
2024-04-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:10:33

Label at a glance#

ProductCarmex Classic Lip Balm Medicated SPF15 Triple Force Formula
Active ingredientOCTINOXATE, OXYBENZONE, WHITE PETROLATUM
Label structure7 sections

Indications and uses

helps protect against sunburn and chapped lips higher SPF gives more sunburn protection

Dosage and administration

apply liberally 15 minutes before sun exposure reapply: at least every 2 hours children under 2 years of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.50%
Oxybenzone 4.00%
White Petrolatum 35.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Suncreen

Lip Protectant

Uses

INDICATIONS & USAGE SECTION

  • helps protect against sunburn and chapped lips
  • higher SPF gives more sunburn protection

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 help prevent sunburn, not skin cancer or early skin aging.

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 a doctor if:

OTC - STOP USE SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply: at least every 2 hours
  • children under 2 years of age: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • this is a personal care item, and should be used by one individual only
  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

lanolin, theobroma cacao seed butter, euphorbia cerifera wax, beeswax, cetyl esters, ozokerite, paraffin, limnanthes alba seed oil, camphor, menthol, salicylic acid, phenol, flavor, vanillin

10210-0066-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackageLabel1.jpgLabel1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10210-0066-1Carmex Classic Lip Balm Medicated SPF15 Triple Force Formula2 in 1 BLISTER PACKSALVE21
10210-0066-1Carmex Classic Lip Balm Medicated SPF15 Triple Force Formula4.25 g in 1 CYLINDERSALVE4.251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10210-0066CARMEX CLASSIC LIP BALM MEDICATED SPF15 TRIPLE FORCE FORMULA (OCTINOXATE, OXYBENZONE, WHITE PETROLATUM) SALVE [CARMA LABORATORIES, INC.]1Current NDC, 2 package rows20240403_3eb0f8ff-89e7-4410-8573-3349e4946548.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10210-006610210-0066-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
LANOLIN7EV65EAW6HIACT
YELLOW WAX2ZA36H0S2VIACT
CETYL ESTERS WAXD072FFP9GUIACT
PARAFFINI9O0E3H2ZEIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
MENTHOLL7T10EIP3AIACT
SALICYLIC ACIDO414PZ4LPZIACT
PHENOL339NCG44TVIACT
VANILLINCHI530446XIACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
WHITE PETROLATUMB6E5W8RQJ4ACTIB

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
Carmex Classic Lip Balm Medicated SPF15 Triple Force FormulaOCTINOXATE, OXYBENZONE, WHITE PETROLATUMCarma Laboratories, Inc.3eb0f8ff-89e7-4410-8573-3349e49465482024-04-02WarningsExact identifier
ndc (package): 10210-0066-1
ndc (product): 10210-0066
ndc11 (package): 10210006601
spl id: 152046a4-b208-8305-e063-6294a90aa7e2
spl set id: 3eb0f8ff-89e7-4410-8573-3349e4946548

Reported adverse events (FAERS/openFDA)#

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