FDA.reportPublic FDA data

OCTINOXATE, OXYBENZONE

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 23:57:40

Label at a glance#

ProductCarmex Daily Care Moisturizing Lip Balm with Free Cupcake Batter Stick Sunscreen SPF 15
Active ingredientOCTINOXATE, OXYBENZONE
Label structure7 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

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

Fresh Cherry, Strawberry

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

Wintergreen

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

Cupcake Batter

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:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label03Label03

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10210-0029-1Carmex Daily Care Moisturizing Lip Balm with Free Cupcake Batter Stick Sunscreen SPF 1510 g in 1 TUBESALVE10 g75 mg in 1g2
10210-0030-1Carmex Daily Care Moisturizing Lip Balm with Free Cupcake Batter Stick Sunscreen SPF 154.25 g in 1 CYLINDERSALVE4.25 g75 mg in 1g2
10210-0032-1Carmex Daily Care Moisturizing Lip Balm with Free Cupcake Batter Stick Sunscreen SPF 1510 g in 1 TUBESALVE10 g75 mg in 1g2
10210-0037-1Carmex Daily Care Moisturizing Lip Balm with Free Cupcake Batter Stick Sunscreen SPF 1510 g in 1 TUBESALVE10 g75 mg in 1g2
10210-0064-1Carmex Daily Care Moisturizing Lip Balm with Free Cupcake Batter Stick Sunscreen SPF 151 in 1 BLISTER PACKKIT12
10210-0064-1Carmex Daily Care Moisturizing Lip Balm with Free Cupcake Batter Stick Sunscreen SPF 151 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10210-0029CARMEX DAILY CARE MOISTURIZING LIP BALM WITH FREE CUPCAKE BATTER STICK SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]2Current NDC, Legacy NDC20231026_2caa7b23-2adb-4953-b044-1b1ad9a5798b.zip
10210-0030CARMEX DAILY CARE MOISTURIZING LIP BALM WITH FREE CUPCAKE BATTER STICK SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]2Current NDC, Legacy NDC20231026_2caa7b23-2adb-4953-b044-1b1ad9a5798b.zip
10210-0032CARMEX DAILY CARE MOISTURIZING LIP BALM WITH FREE CUPCAKE BATTER STICK SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]2Current NDC, Legacy NDC20231026_2caa7b23-2adb-4953-b044-1b1ad9a5798b.zip
10210-0037CARMEX DAILY CARE MOISTURIZING LIP BALM WITH FREE CUPCAKE BATTER STICK SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]2Current NDC, Legacy NDC20231026_2caa7b23-2adb-4953-b044-1b1ad9a5798b.zip
10210-0064CARMEX DAILY CARE MOISTURIZING LIP BALM WITH FREE CUPCAKE BATTER STICK SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]2Current NDC, 6 package rows20231026_2caa7b23-2adb-4953-b044-1b1ad9a5798b.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10210-006410210-0064-1
10210-003210210-0032-1
10210-002910210-0029-1
10210-003710210-0037-1
10210-003010210-0030-1

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
ISOPROPYL PALMITATE8CRQ2TH63MIACT
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 · 17 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 (package): 10210-0032-1
ndc (product): 10210-0032
ndc11 (package): 10210003201
Carmex Daily Care Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.26f8dc88-2096-4fa1-81ae-ea92fe1f353d2025-04-07WarningsExact identifier
ndc (package): 10210-0030-1
ndc11 (package): 10210003001
Carmex Variety Pack Daily Care Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.c7142781-fa57-43e5-9436-cb29dd03a6692025-03-21WarningsExact identifier
ndc (package): 10210-0030-1
ndc (package): 10210-0032-1
ndc11 (package): 10210003201
ndc11 (package): 10210003001
Carmex Variety Pack Daily Care Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECarma Laboratories, Inc.30de3d87-6cc7-b779-e063-6294a90a72f42025-03-21WarningsExact identifier
ndc (package): 10210-0037-1
ndc (package): 10210-0032-1
ndc (package): 10210-0029-1
ndc11 (package): 10210003201
ndc11 (package): 10210002901
ndc11 (package): 10210003701
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.5e2d7c94-d70a-47e4-9a4b-5953fe38ede22025-03-19WarningsExact identifier
ndc (package): 10210-0037-1
ndc (package): 10210-0032-1
ndc (package): 10210-0029-1
ndc11 (package): 10210003201
ndc11 (package): 10210002901
ndc11 (package): 10210003701
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.50206f9e-2dd5-494f-9eed-f7d7ea6efda92025-03-18WarningsExact identifier
ndc (package): 10210-0037-1
ndc (package): 10210-0032-1
ndc (package): 10210-0029-1
ndc11 (package): 10210003201
ndc11 (package): 10210002901
ndc11 (package): 10210003701
Carmex Daily Care Moisturizing Lip Balm Wintergreen SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb013e70-f081-f8f2-e053-2995a90a19812023-12-29WarningsExact identifier
ndc (package): 10210-0037-1
ndc (product): 10210-0037
ndc11 (package): 10210003701
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.0bc6812a-5c2a-7bb9-e063-6294a90a36e32023-12-05WarningsExact identifier
ndc (package): 10210-0030-1
ndc11 (package): 10210003001
Carmex Daily Care Moisturizing Lip Balm Cupcake Batter SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baec9be7-5ae6-135c-e053-2995a90a2ed42023-10-25WarningsExact identifier
ndc (package): 10210-0030-1
ndc (product): 10210-0030
ndc11 (package): 10210003001
Carmex Daily Care Moisturizing Lip Balm Fresh Cherry SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baea3596-6eb0-4d98-e053-2995a90a75cc2023-10-25WarningsExact identifier
ndc (package): 10210-0029-1
ndc (product): 10210-0029
ndc11 (package): 10210002901
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): 10210-0030-1
ndc11 (package): 10210003001
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): 10210-0030-1
ndc11 (package): 10210003001
Carmex Daily Care Moisturizing Lip Balm Sweets SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb62d499-1d78-1324-e053-2a95a90abe3c2023-10-25WarningsExact identifier
ndc (package): 10210-0030-1
ndc11 (package): 10210003001
Carmex Daily Care Moisturizing Lip Balm Sunscreen SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.f3eb98dc-9ab3-4123-9490-a1bbf9b3259a2023-10-25WarningsExact identifier
ndc (package): 10210-0037-1
ndc (package): 10210-0032-1
ndc (package): 10210-0029-1
ndc11 (package): 10210003201
ndc11 (package): 10210002901
ndc11 (package): 10210003701
Carmex Daily Care Moisturizing Lip Balm SPF 15 AssortedOCTINOXATE, OXYBENZONECarma Laboratories, Inc.bb132025-658f-d6f8-e053-2995a90a089b2023-10-25WarningsExact identifier
ndc (package): 10210-0037-1
ndc (package): 10210-0032-1
ndc (package): 10210-0029-1
ndc11 (package): 10210003201
ndc11 (package): 10210002901
ndc11 (package): 10210003701
Carmex Daily Care Moisturizing Lip Balm with Free Cupcake Batter Stick Sunscreen SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.2caa7b23-2adb-4953-b044-1b1ad9a5798b2023-10-25WarningsExact identifier
ndc (package): 10210-0037-1
ndc (package): 10210-0064-1
ndc (package): 10210-0030-1
ndc (package): 10210-0032-1
ndc (package): 10210-0029-1
ndc (product): 10210-0064
ndc11 (package): 10210003201
ndc11 (package): 10210003001
ndc11 (package): 10210002901
ndc11 (package): 10210003701
ndc11 (package): 10210006401
spl id: 08884106-3dfd-cf63-e063-6394a90ab094
spl set id: 2caa7b23-2adb-4953-b044-1b1ad9a5798b
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), PETROLATUMCarma Laboratories, Inc.5378d653-702d-405c-a067-882554aaf93a2023-08-21WarningsExact identifier
ndc (package): 10210-0030-1
ndc11 (package): 10210003001

Reported adverse events (FAERS/openFDA)#

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