FDA.reportPublic FDA data

Carmex Daily Care moisturizing Lip Balm Winter Mint SPF 15

Manufacturer
Carma Laboratories, Inc.
Effective date
2023-10-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:57:41

Label at a glance#

ProductCarmex Daily Care moisturizing Lip Balm Winter Mint SPF 15
Active ingredientOCTINOXATE, OXYBENZONE
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: • after 80 minutes of swimming or sweating • immediately after towel drying • 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%

Purpose

OTC - PURPOSE SECTION

Sunscreen

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

Stop use and ask a doctor if:

OTC - STOP USE SECTION

rash occurs

When using this product:

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

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: • after 80 minutes of swimming or sweating • immediately after towel drying • 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
  • do not use if safety seal is broken prior to purchase

Inactive Ingredients

INACTIVE INGREDIENT SECTION

petrolatum, lanolin, euphorbia cerifera cera, isopropyl palmitate, ozokerite, beeswax, cetly esters, paraffin, theobroma cacao seed butter, flavor, limnanthes alba seed oil, stevia rebaudiana extract

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Winter MintWinter Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10210-0016-1Carmex Daily Care moisturizing Lip Balm Winter Mint SPF 151 in 1 CARTONSALVE12
10210-0016-1Carmex Daily Care moisturizing Lip Balm Winter Mint SPF 154.25 g in 1 CYLINDERSALVE4.252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10210-0016CARMEX DAILY CARE MOISTURIZING LIP BALM WINTER MINT SPF 15 (OCTINOXATE, OXYBENZONE) SALVE [CARMA LABORATORIES, INC.]2Current NDC, Legacy NDC, 2 package rows20231026_41e4fca8-22c0-4a8a-95d3-e4aad559548a.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10210-001610210-0016-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
LANOLIN7EV65EAW6HIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CERESINQ1LS2UJO3AIACT
METHYL SALICYLATELAV5U5022YIACT
YELLOW WAX2ZA36H0S2VIACT
CETYL ESTERS WAXD072FFP9GUIACT
PARAFFINI9O0E3H2ZEIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB

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 Daily Care moisturizing Lip Balm Winter Mint SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.41e4fca8-22c0-4a8a-95d3-e4aad559548a2023-10-25WarningsExact identifier
ndc (package): 10210-0016-1
ndc (product): 10210-0016
ndc11 (package): 10210001601
spl id: 08883535-87aa-c510-e063-6294a90a33ac
spl set id: 41e4fca8-22c0-4a8a-95d3-e4aad559548a

Reported adverse events (FAERS/openFDA)#

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