FDA.reportPublic FDA data

Carmex Daily Care Moisturizing Lip Balm SPF 15 Sunscreen Minis

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 23:57:42

Label at a glance#

ProductCarmex Daily Care Moisturizing Lip Balm SPF 15 Sunscreen Minis
Active ingredientOCTINOXATE, OXYBENZONE
Label structure6 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, skin cancer or early skin aging. Skin Cancer/Skin Aging Alert: not

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Strawberry, Wild Berry & Peach Mango

petrolatum, lanolin, beeswax, cetyl esters, isopropyl palmitate, theobroma cacao seed butter, flavor, limnanthes alba seed oil, polypropylene, isohexadecane, polyamide 8, polyhydroxystearic acid, stevia rebaudiana extract

petrolatum, lanolin, beeswax, cetyl esters, isopropyl palmitate, theobroma cacao seed butter, limnanthes alba seed oil, polypropylene, isohexadecane, polyamide 8, polyhydroxystearic acid, stevia rebaudiana extract Cool Mint

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label04Label04

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10210-0032-0Carmex Daily Care Moisturizing Lip Balm SPF 15 Sunscreen Minis5 g in 1 TUBESALVE5 g75 mg in 1g2
10210-0034-0Carmex Daily Care Moisturizing Lip Balm SPF 15 Sunscreen Minis5 g in 1 TUBESALVE5 g75 mg in 1g2
10210-0035-0Carmex Daily Care Moisturizing Lip Balm SPF 15 Sunscreen Minis5 g in 1 TUBESALVE5 g75 mg in 1g2
10210-0036-0Carmex Daily Care Moisturizing Lip Balm SPF 15 Sunscreen Minis5 g in 1 TUBESALVE5 g75 mg in 1g2
10210-0065-1Carmex Daily Care Moisturizing Lip Balm SPF 15 Sunscreen Minis1 in 1 KITKIT12
10210-0065-1Carmex Daily Care Moisturizing Lip Balm SPF 15 Sunscreen Minis1 in 1 TRAYKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10210-0032CARMEX DAILY CARE MOISTURIZING LIP BALM SPF 15 SUNSCREEN MINIS (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]2Current NDC, Legacy NDC20231026_4e868b1a-7c47-45de-83cd-0bd5fbb05a27.zip
10210-0034CARMEX DAILY CARE MOISTURIZING LIP BALM SPF 15 SUNSCREEN MINIS (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]2Unmatched20231026_4e868b1a-7c47-45de-83cd-0bd5fbb05a27.zip
10210-0035CARMEX DAILY CARE MOISTURIZING LIP BALM SPF 15 SUNSCREEN MINIS (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]2Unmatched20231026_4e868b1a-7c47-45de-83cd-0bd5fbb05a27.zip
10210-0036CARMEX DAILY CARE MOISTURIZING LIP BALM SPF 15 SUNSCREEN MINIS (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]2Unmatched20231026_4e868b1a-7c47-45de-83cd-0bd5fbb05a27.zip
10210-0065CARMEX DAILY CARE MOISTURIZING LIP BALM SPF 15 SUNSCREEN MINIS (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]2Current NDC, 6 package rows20231026_4e868b1a-7c47-45de-83cd-0bd5fbb05a27.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
10210-006510210-0065-1
10210-003210210-0032-0
10210-003410210-0034-0
10210-003510210-0035-0
10210-003610210-0036-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
LANOLIN7EV65EAW6HIACT
YELLOW WAX2ZA36H0S2VIACT
CETYL ESTERS WAXD072FFP9GUIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
ISOHEXADECANE918X1OUF1EIACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
PETROLATUM4T6H12BN9UIACT
LANOLIN7EV65EAW6HIACT
YELLOW WAX2ZA36H0S2VIACT
CETYL ESTERS WAXD072FFP9GUIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
ISOHEXADECANE918X1OUF1EIACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
PETROLATUM4T6H12BN9UIACT
LANOLIN7EV65EAW6HIACT
YELLOW WAX2ZA36H0S2VIACT
CETYL ESTERS WAXD072FFP9GUIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
ISOHEXADECANE918X1OUF1EIACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
PETROLATUM4T6H12BN9UIACT
LANOLIN7EV65EAW6HIACT
YELLOW WAX2ZA36H0S2VIACT
CETYL ESTERS WAXD072FFP9GUIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
ISOHEXADECANE918X1OUF1EIACT
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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carmex Daily Care Moisturizing Lip Balm Strawberry SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baee366f-c1a0-5e21-e053-2a95a90a66872026-05-05WarningsExact identifier
ndc (product): 10210-0032
Carmex Daily Care Moisturizing Lip Balm SPF 15 Sunscreen MinisOCTINOXATE, OXYBENZONECarma Laboratories, Inc.4e868b1a-7c47-45de-83cd-0bd5fbb05a272023-10-25WarningsExact identifier
ndc (package): 10210-0035-0
ndc (package): 10210-0032-0
ndc (package): 10210-0036-0
ndc (package): 10210-0034-0
ndc (package): 10210-0065-1
ndc (product): 10210-0065
ndc11 (package): 10210006501
ndc11 (package): 10210003400
ndc11 (package): 10210003200
ndc11 (package): 10210003500
ndc11 (package): 10210003600
spl id: 08883637-b86d-23dc-e063-6394a90ae9f7
spl set id: 4e868b1a-7c47-45de-83cd-0bd5fbb05a27
Carmex Daily Care Moisturizing Lip Balm SPF 15 MinisOCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb029c71-4f07-2754-e053-2995a90a7c782023-10-25WarningsExact identifier
ndc (package): 10210-0035-0
ndc (package): 10210-0032-0
ndc (package): 10210-0036-0
ndc (package): 10210-0034-0
ndc11 (package): 10210003400
ndc11 (package): 10210003200
ndc11 (package): 10210003500
ndc11 (package): 10210003600

Reported adverse events (FAERS/openFDA)#

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