FDA.reportPublic FDA data

Carmex Daily Care Moisturizing Lip SPF 15 Assorted

Manufacturer
Carma Laboratories, Inc.
Effective date
2024-04-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:10:45

Label at a glance#

ProductCarmex Daily Care Moisturizing Lip SPF 15 Assorted
Active ingredientHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE
Label structure9 sections

Indications and uses

helps prevent sunburn higher SPF gives more sunburn protection provides moderate protection against sunburn  if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

apply generously and evenly 15 minutes before sun exposure children under 6 months: Ask a doctor  reapply: as needed ot after towel drying, swimming or sweating Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especi...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate (7.0%)

Octocrylene (5.3%)

Octisalate (3.3%)

Avobenzone (2.4%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • provides moderate protection against sunburn 
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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 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 Posion Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply generously and evenly 15 minutes before sun exposure
  • children under 6 months: Ask a doctor 
  • reapply: as needed ot after towel drying, swimming or sweating

Sun Protection Measures:Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen SPF value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses

Inactve ingredients

INACTIVE INGREDIENT SECTION

Wintergreen:petrolatum, lanolin, euphorbia cerifera (candelilla) wax, ozokerite, beeswax, cetyl esters, paraffin, theobroma cacao (cocoa) seed butter, flavor, isopropyl palmitate, limnanthes alba (meadowfoam) seed oil, stevia rebaudiana extract 

Fresh Cherry, Strawberry:petrolatum, lanolin, euphorbia cerifera (candelilla) wax, ozokerite, flavor, beeswax, cetyl esters, paraffin, theobroma cacao (cocoa) seed butter, isopropyl palmitate, limnanthes alba (meadowfoam) seed oil, stevia rebaudiana extract

10210-0078-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

kitkit

Kit2Kit2

Package Labeling:FRESH CHERRY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FRESH CHERRYFRESH CHERRY

Package Labeling:STRAWBERRY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STRAWBERRYSTRAWBERRY

Package Labeling:WINTERGREEN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WINTERGREENWINTERGREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10210-0078-1Carmex Daily Care Moisturizing Lip SPF 15 Assorted1 in 1 KITKIT13
10210-0078-1Carmex Daily Care Moisturizing Lip SPF 15 Assorted1 in 1 TRAYKIT13
10210-0079-1Carmex Daily Care Moisturizing Lip SPF 15 Assorted4.5 g in 1 CYLINDERSALVE4.5 g53 mg in 1g3
10210-0080-1Carmex Daily Care Moisturizing Lip SPF 15 Assorted4.5 g in 1 CYLINDERSALVE9 g24 mg in 1g3
10210-0081-1Carmex Daily Care Moisturizing Lip SPF 15 Assorted4.5 g in 1 CYLINDERSALVE4.5 g24 mg in 1g3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10210-0078CARMEX DAILY CARE MOISTURIZING LIP SPF 15 ASSORTED (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) KIT [CARMA LABORATORIES, INC.]3Current NDC, 5 package rows20240407_ff9eae5b-4963-429d-bb73-8e3b5402f084.zip
10210-0079CARMEX DAILY CARE MOISTURIZING LIP SPF 15 ASSORTED (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) KIT [CARMA LABORATORIES, INC.]3Unmatched20240407_ff9eae5b-4963-429d-bb73-8e3b5402f084.zip
10210-0080CARMEX DAILY CARE MOISTURIZING LIP SPF 15 ASSORTED (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) KIT [CARMA LABORATORIES, INC.]3Unmatched20240407_ff9eae5b-4963-429d-bb73-8e3b5402f084.zip
10210-0081CARMEX DAILY CARE MOISTURIZING LIP SPF 15 ASSORTED (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) KIT [CARMA LABORATORIES, INC.]3Unmatched20240407_ff9eae5b-4963-429d-bb73-8e3b5402f084.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10210-007810210-0078-1
10210-007910210-0079-1
10210-008010210-0080-1
10210-008110210-0081-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
LANOLIN7EV65EAW6HIACT
CANDELILLA WAXWL0328HX19IACT
YELLOW WAX2ZA36H0S2VIACT
CETYL ESTERS WAXD072FFP9GUIACT
PARAFFINI9O0E3H2ZEIACT
COCOA BUTTER512OYT1CRRIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
PETROLATUM4T6H12BN9UIACT
LANOLIN7EV65EAW6HIACT
CANDELILLA WAXWL0328HX19IACT
YELLOW WAX2ZA36H0S2VIACT
CETYL ESTERS WAXD072FFP9GUIACT
PARAFFINI9O0E3H2ZEIACT
COCOA BUTTER512OYT1CRRIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
PETROLATUM4T6H12BN9UIACT
LANOLIN7EV65EAW6HIACT
CANDELILLA WAXWL0328HX19IACT
YELLOW WAX2ZA36H0S2VIACT
CETYL ESTERS WAXD072FFP9GUIACT
PARAFFINI9O0E3H2ZEIACT
COCOA BUTTER512OYT1CRRIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB

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 SPF 15 AssortedHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECarma Laboratories, Inc.ff9eae5b-4963-429d-bb73-8e3b5402f0842024-04-05WarningsExact identifier
ndc (package): 10210-0078-1
ndc (package): 10210-0081-1
ndc (package): 10210-0079-1
ndc (package): 10210-0080-1
ndc (product): 10210-0078
ndc11 (package): 10210007801
ndc11 (package): 10210008001
ndc11 (package): 10210008101
ndc11 (package): 10210007901
spl id: 155e423c-6928-4f80-e063-6394a90ac8e6
spl set id: ff9eae5b-4963-429d-bb73-8e3b5402f084

Reported adverse events (FAERS/openFDA)#

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