FDA.reportPublic FDA data

Carmex Classic Lip Balm Medicated SPF 15

Manufacturer
Carma Laboratories, Inc.
Effective date
2023-10-25
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:57:52

Label at a glance#

ProductCarmex Classic Lip Balm Medicated SPF 15
Active ingredientOCTINOXATE, OXYBENZONE, WHITE PETROLATUM
Label structure9 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: 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

Lip Protectant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

 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. Skin Cancer/Skin Aging Alert:

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: 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
  • do not use if safety seal is broken prior to purchase

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

Package Labeling:10210-0023-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medicated SPFMedicated SPF

Package Labeling: 10210-0023-4

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:10210-0023-5

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label02Label02

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10210-0023-1Carmex Classic Lip Balm Medicated SPF 154.25 g in 1 CYLINDERSALVE4.256
10210-0023-2Carmex Classic Lip Balm Medicated SPF 153 in 1 PACKAGESALVE36
10210-0023-2Carmex Classic Lip Balm Medicated SPF 154.25 g in 1 CYLINDERSALVE4.256
10210-0023-3Carmex Classic Lip Balm Medicated SPF 151 in 1 CARTONSALVE16
10210-0023-3Carmex Classic Lip Balm Medicated SPF 154.25 g in 1 CYLINDERSALVE4.256
10210-0023-4Carmex Classic Lip Balm Medicated SPF 154 in 1 TRAYSALVE46
10210-0023-4Carmex Classic Lip Balm Medicated SPF 154.25 g in 1 CYLINDERSALVE4.256
10210-0023-5Carmex Classic Lip Balm Medicated SPF 154.25 g in 1 CYLINDERSALVE4.256
10210-0023-5Carmex Classic Lip Balm Medicated SPF 1524 in 1 BOXSALVE246

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10210-0023CARMEX CLASSIC LIP BALM MEDICATED SPF 15 (OCTINOXATE, OXYBENZONE, PETROLATUM) SALVE [CARMA LABORATORIES, INC.]6Current NDC, Legacy NDC, 9 package rows20231026_ca20b2dc-97e5-461a-94c8-5c109cd15285.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
10210-002310210-0023-1, 10210-0023-2, 10210-0023-3, 10210-0023-4, 10210-0023-5

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
CERESINQ1LS2UJO3AIACT
PARAFFINI9O0E3H2ZEIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carmex 10 count variety pack Lip BalmOCTINOXATE, OXYBENZONE, CAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.9c5168d5-31ed-4ce1-b16a-5f51f7e44ed22026-04-30WarningsExact identifier
ndc (package): 10210-0023-1
ndc11 (package): 10210002301
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.3a3af6e1-0281-462e-85e7-144cc5d46f322025-03-19WarningsExact identifier
ndc (package): 10210-0023-1
ndc11 (package): 10210002301
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.c04059e9-8175-46c2-8582-f84ef193abd32025-03-19WarningsExact identifier
ndc (package): 10210-0023-1
ndc11 (package): 10210002301
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.3a36a241-37a9-445a-a6e0-97709a7457a82025-03-19WarningsExact identifier
ndc (package): 10210-0023-1
ndc11 (package): 10210002301
Carmex 10 Count Variety Pack SPF 15 SunscreenOCTINOXATE, OXYBENZONE, PETROLATUMCarma Laboratories, Inc.bacc60ec-0b6a-4ba2-b246-a59694f06b772023-10-25WarningsExact identifier
ndc (package): 10210-0023-1
ndc11 (package): 10210002301
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15OCTINOXATE, OXYBENZONE, WHITE PETROLATUMCarma Laboratories, Inc.5720bd35-de4a-4db4-a4df-0fbc59719bfd2023-10-25WarningsExact identifier
ndc (package): 10210-0023-1
ndc11 (package): 10210002301
Carmex Classic Lip Balm Medicated SPF 15OCTINOXATE, OXYBENZONE, PETROLATUMCarma Laboratories, Inc.ca20b2dc-97e5-461a-94c8-5c109cd152852023-10-25WarningsExact identifier
ndc (package): 10210-0023-2
ndc (package): 10210-0023-4
ndc (package): 10210-0023-3
ndc (package): 10210-0023-1
ndc (package): 10210-0023-5
ndc (product): 10210-0023
ndc11 (package): 10210002304
ndc11 (package): 10210002305
ndc11 (package): 10210002303
ndc11 (package): 10210002302
ndc11 (package): 10210002301
spl id: 088825e1-7f9e-23b3-e063-6394a90a58db
spl set id: ca20b2dc-97e5-461a-94c8-5c109cd15285

Reported adverse events (FAERS/openFDA)#

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