FDA.reportPublic FDA data

Carmex Daily Care Moisturizing Lip Balm Wintergreen SPF 15

Product NDC
10210-0033
11-digit product format
102100033
Labeler code
10210
Product ID
10210-0033_0da943c7-e1e9-d090-e063-6294a90a07cc
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OXYBENZONE
Dosage form
SALVE
Route
TOPICAL
Labeler
Carma Laboratories, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-20
Substance
OCTINOXATE; OXYBENZONE
Active strength
75; 40 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Carmex Daily Care Moisturizing Lip Balm Wintergreen SPF 15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE75 mg/g
OXYBENZONE40 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
baff2dfe-fd0b-0709-e053-2a95a90a431bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10210-0033-1Carmex 10 Count Variety Pack SPF 15 Sunscreen4.25 g in 1 CYLINDERSALVE8.5 g75 mg in 1g3
10210-0033-1Carmex Classic Lip Balm Medicated Free Wintergreen Stick4.25 g in 1 CYLINDERSALVE4.25 g75 mg in 1g3
10210-0033-1Carmex Daily Care Moisturizing Lip Balm Free Cupcake Batter Stick Sunscreen SPF 154.25 g in 1 CYLINDERSALVE4.25 g75 mg in 1g2
10210-0033-1Carmex Daily Care Moisturizing Lip Balm Wintergreen SPF 154.25 g in 1 CYLINDERSALVE4.252
10210-0033-1Carmex Daily Care Moisturizing Lip Balm Holiday SPF 154.25 g in 1 CYLINDERSALVE4.25 g75 mg in 1g2
10210-0033-1Carmex Daily Care Moisturizing Lip Balm SPF 15 Assorted4.25 g in 1 CYLINDERSALVE4.25 g75 mg in 1g2
10210-0033-1Carmex Daily Care Moisturizing Lip Balm Free Wintergreen and Fresh Cherry SPF 154.25 g in 1 CYLINDERSALVE4.25 g75 mg in 1g2
10210-0033-1Carmex Daily Care Moisturizing Lip Balm Favorites SPF 154.25 g in 1 CYLINDERSALVE4.25 g75 mg in 1g2
10210-0033-1Carmex Variety Pack Daily Care Moisturizing Lip Balm SPF 154.25 g in 1 CYLINDERSALVE4.25 g40 mg in 1g1
10210-0033-1Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 154.25 g in 1 CYLINDERSALVE4.25 g75 mg in 1g1
10210-0033-1Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 154.25 g in 1 CYLINDERSALVE8.5 g75 mg in 1g1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10210-0033CARMEX 10 COUNT VARIETY PACK SPF 15 SUNSCREEN (OCTINOXATE, OXYBENZONE, PETROLATUM) KIT [CARMA LABORATORIES, INC.]3Current NDC, Legacy NDC20231026_bacc60ec-0b6a-4ba2-b246-a59694f06b77.zip
10210-0033CARMEX CLASSIC LIP BALM MEDICATED FREE WINTERGREEN STICK (OCTINOXATE, OXYBENZONE, CAMPHOR (SYNTHETIC), WHITE PETROLATUM) KIT [CARMA LABORATORIES, INC.]3Current NDC, Legacy NDC20231209_bc0162bc-92ca-ee78-e053-2a95a90a7c9d.zip
10210-0033CARMEX DAILY CARE MOISTURIZING LIP BALM FAVORITES SPF 15 (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]2Current NDC, Legacy NDC20231026_bb611c57-a8ac-0c23-e053-2995a90a5b40.zip
10210-0033CARMEX DAILY CARE MOISTURIZING LIP BALM FREE CUPCAKE BATTER STICK SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]2Current NDC, Legacy NDC20231026_6ef888a3-77c0-498f-92c4-d482cf96ef46.zip
10210-0033CARMEX DAILY CARE MOISTURIZING LIP BALM FREE WINTERGREEN AND FRESH CHERRY SPF 15 (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]2Current NDC, Legacy NDC20231026_bb28c2e7-4189-fc11-e053-2995a90a92ad.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
10210-0033CARMEX DAILY CARE MOISTURIZING LIP BALM SPF 15 ASSORTED (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]2Current NDC, Legacy NDC20231026_bb6086c1-f775-70ed-e053-2995a90a531e.zip
10210-0033CARMEX DAILY CARE MOISTURIZING LIP BALM WINTERGREEN SPF 15 (OCTINOXATE, OXYBENZONE) SALVE [CARMA LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20231230_baff2dfe-fd0b-0709-e053-2a95a90a431b.zip
10210-0033CARMEX VARIETY PACK DAILY CARE MOISTURIZING LIP BALM SPF 15 (OCTINOXATE, OXYBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE) KIT [CARMA LABORATORIES, INC.]1Current NDC, Legacy NDC20250402_d8ad45dc-e0ec-4324-b93e-8cf405d1d471.zip
10210-0033CARMEX VARIETY PACK DAILY CARE STICKS MOISTURIZING LIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]1Current NDC, Legacy NDC20250402_50206f9e-2dd5-494f-9eed-f7d7ea6efda9.zip
10210-0033CARMEX VARIETY PACK DAILY CARE STICKS MOISTURIZING LIP BALM SPF 15 (OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]1Current NDC, Legacy NDC20250402_5e2d7c94-d70a-47e4-9a4b-5953fe38ede2.zip

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 95 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Kids Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc240dd76a-8f39-caec-e063-6294a90abbbc2025-12-31WarningsExact identifier
application number: M020
Coppertone Protect and Tan SPF 30AVOBENZONE 3%, HOMOSALATE 14%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3994886-2ebe-a9d2-e053-2995a90aaf9a2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3d471b8-7430-98b0-e053-2995a90aba4b2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc241f78be-0d7f-c5ca-e063-6294a90a997a2025-12-31WarningsExact identifier
application number: M020
Coppertone Protect and Tan Sunscreen SPF 45AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdort Incd39a009d-1f33-88bb-e053-2a95a90a03a02025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd460d669-42df-46c0-e053-2a95a90ad77b2025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 8AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incd370094c-3373-594b-e053-2a95a90a114a2025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15(TO DELIVER) AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inc0a5a35be-9e24-18dd-e063-6394a90a097f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd462081f-f082-5df2-e053-2995a90aa1d92025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3e66496-bc3c-d189-e053-2a95a90a06b62025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inc.c05388dc-4282-ee79-e053-2a95a90a376a2025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incb60dcbd1-42d0-646f-e053-2a95a90a497d2025-12-31WarningsExact identifier
application number: M020
Coppertone Complete Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd474fea9-65a7-672b-e053-2a95a90ab9892025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 40AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Incd4d9ad73-6394-2391-e053-2a95a90a2df62025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 100AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incdf498e82-e1c9-51eb-e053-2a95a90a49b62025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incd3984138-763b-1002-e053-2995a90acefc2025-12-31WarningsExact identifier
application number: M020
Coppertone Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8%Beiersdorf Incd8b0d5ad-a82c-5304-e053-2a95a90afa632025-12-31WarningsExact identifier
application number: M020
Coppertone Pure and Simple Sunscreen SPF 50ZINC OXIDE 24.08%Beiersdorf Incd8d80a15-8282-a18e-e053-2a95a90a2c6c2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd915cb28-2813-5a38-e053-2a95a90a45c62025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 15AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd46052d3-6f45-5f4d-e053-2995a90a87602025-12-31WarningsExact identifier
application number: M020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentPSNbc0162bc-92ca-ee78-e053-2a95a90a7c9d3
2475168camphor 0.017 MG/MG / petrolatum 0.453 MG/MG Topical OintmentSCDbc0162bc-92ca-ee78-e053-2a95a90a7c9d3
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentSYbc0162bc-92ca-ee78-e053-2a95a90a7c9d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10210-0033-1102100033014.25 g in 1 CYLINDER (10210-0033-1) 4.25 g2018-06-200000-00-00NoNoCurrent