FDA.reportPublic FDA data

Carmex Daily Care Moisturizing Lip Balm Holiday 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 23:57:51

Label at a glance#

ProductCarmex Daily Care Moisturizing Lip Balm Holiday SPF 15
Active ingredientOCTINOXATE, OXYBENZONE
Label structure17 sections

Indications and uses

• helps protect against sunburn • 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 • 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: • 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 wax, isopropyl palmitate, ozokerite, flavor, beeswax, cetyl esters, paraffin, theobroma cacao seed butter, limnanthes alba seed oil, stevia rebaudiana extract

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 • 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: • 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 wax, isopropyl palmitate, ozokerite, beeswax, cetyl esters, paraffin, theobroma cacao seed butter, flavor,  limnanthes alba seed oil, stevia rebaudiana extract

Package Labeling:10210-0049-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KitKit

Package Labeling:10210-0050-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:10210-0051-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label4label4

Package Labeling:10210-0052-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling:10210-0033-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10210-0033-1Carmex Daily Care Moisturizing Lip Balm Holiday SPF 154.25 g in 1 CYLINDERSALVE4.25 g75 mg in 1g2
10210-0049-1Carmex Daily Care Moisturizing Lip Balm Holiday SPF 151 in 1 KITKIT12
10210-0050-1Carmex Daily Care Moisturizing Lip Balm Holiday SPF 154.25 g in 1 CYLINDERSALVE4.25 g75 mg in 1g2
10210-0051-1Carmex Daily Care Moisturizing Lip Balm Holiday SPF 154.25 g in 1 CYLINDERSALVE4.25 g75 mg in 1g2
10210-0052-1Carmex Daily Care Moisturizing Lip Balm Holiday SPF 154.25 g in 1 CYLINDERSALVE4.25 g75 mg in 1g2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10210-0033CARMEX DAILY CARE MOISTURIZING LIP BALM HOLIDAY SPF 15 (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]2Current NDC, Legacy NDC20231026_bbf118c0-7cd5-5a82-e053-2a95a90ac8c8.zip
10210-0049CARMEX DAILY CARE MOISTURIZING LIP BALM HOLIDAY SPF 15 (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]2Current NDC, Legacy NDC, 5 package rows20231026_bbf118c0-7cd5-5a82-e053-2a95a90ac8c8.zip
10210-0050CARMEX DAILY CARE MOISTURIZING LIP BALM HOLIDAY SPF 15 (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]2Unmatched20231026_bbf118c0-7cd5-5a82-e053-2a95a90ac8c8.zip
10210-0051CARMEX DAILY CARE MOISTURIZING LIP BALM HOLIDAY SPF 15 (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]2Unmatched20231026_bbf118c0-7cd5-5a82-e053-2a95a90ac8c8.zip
10210-0052CARMEX DAILY CARE MOISTURIZING LIP BALM HOLIDAY SPF 15 (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]2Unmatched20231026_bbf118c0-7cd5-5a82-e053-2a95a90ac8c8.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10210-004910210-0049-1
10210-005010210-0050-1
10210-005110210-0051-1
10210-005210210-0052-1
10210-003310210-0033-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

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

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carmex Variety Pack Daily Care Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECarma Laboratories, Inc.d8ad45dc-e0ec-4324-b93e-8cf405d1d4712025-03-20WarningsExact identifier
ndc (package): 10210-0033-1
ndc11 (package): 10210003301
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.5e2d7c94-d70a-47e4-9a4b-5953fe38ede22025-03-19WarningsExact identifier
ndc (package): 10210-0033-1
ndc11 (package): 10210003301
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.50206f9e-2dd5-494f-9eed-f7d7ea6efda92025-03-18WarningsExact identifier
ndc (package): 10210-0033-1
ndc11 (package): 10210003301
Carmex Daily Care Moisturizing Lip Balm Wintergreen SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baff2dfe-fd0b-0709-e053-2a95a90a431b2023-12-29WarningsExact identifier
ndc (package): 10210-0033-1
ndc (product): 10210-0033
ndc11 (package): 10210003301
Carmex Classic Lip Balm Medicated Free Wintergreen StickOCTINOXATE, OXYBENZONE, CAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.bc0162bc-92ca-ee78-e053-2a95a90a7c9d2023-12-08WarningsExact identifier
ndc (package): 10210-0033-1
ndc11 (package): 10210003301
Carmex 10 Count Variety Pack SPF 15 SunscreenOCTINOXATE, OXYBENZONE, PETROLATUMCarma Laboratories, Inc.bacc60ec-0b6a-4ba2-b246-a59694f06b772023-10-25WarningsExact identifier
ndc (package): 10210-0033-1
ndc11 (package): 10210003301
Carmex Daily Care Moisturizing Lip Balm Free Cupcake Batter Stick Sunscreen SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.6ef888a3-77c0-498f-92c4-d482cf96ef462023-10-25WarningsExact identifier
ndc (package): 10210-0033-1
ndc11 (package): 10210003301
Carmex Daily Care Moisturizing Lip Balm SPF 15 AssortedOCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb6086c1-f775-70ed-e053-2995a90a531e2023-10-25WarningsExact identifier
ndc (package): 10210-0033-1
ndc11 (package): 10210003301
Carmex Daily Care Moisturizing Lip Balm Free Wintergreen and Fresh Cherry SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb28c2e7-4189-fc11-e053-2995a90a92ad2023-10-25WarningsExact identifier
ndc (package): 10210-0033-1
ndc11 (package): 10210003301
Carmex Daily Care Moisturizing Lip Balm Favorites SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb611c57-a8ac-0c23-e053-2995a90a5b402023-10-25WarningsExact identifier
ndc (package): 10210-0033-1
ndc11 (package): 10210003301
Carmex Daily Care Moisturizing Lip Balm Holiday SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bbf118c0-7cd5-5a82-e053-2a95a90ac8c82023-10-25WarningsExact identifier
ndc (package): 10210-0051-1
ndc (package): 10210-0050-1
ndc (package): 10210-0052-1
ndc (package): 10210-0033-1
ndc (package): 10210-0049-1
ndc (product): 10210-0049
ndc11 (package): 10210005001
ndc11 (package): 10210003301
ndc11 (package): 10210005101
ndc11 (package): 10210005201
ndc11 (package): 10210004901
spl id: 088887f7-e01a-d47a-e063-6294a90a00df
spl set id: bbf118c0-7cd5-5a82-e053-2a95a90ac8c8

Reported adverse events (FAERS/openFDA)#

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