FDA.reportPublic FDA data

Carmex Classic Lip Balm Medicated SPF 15

Product NDC
10210-0023
11-digit product format
102100023
Labeler code
10210
Product ID
10210-0023_088825e1-7f9e-23b3-e063-6394a90a58db
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OXYBENZONE, PETROLATUM
Dosage form
SALVE
Route
TOPICAL
Labeler
Carma Laboratories, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-09-26
Substance
OCTINOXATE; OXYBENZONE; WHITE PETROLATUM
Active strength
7.5; 4; 35 g/100g; g/100g; g/100g
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 Classic Lip Balm Medicated SPF 15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE7.5 g/100g
OXYBENZONE4 g/100g
WHITE PETROLATUM35 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
95OOS7VE0YInternal UNII lookup
B6E5W8RQJ4Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ca20b2dc-97e5-461a-94c8-5c109cd15285Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10210-0023-1Carmex Classic Lip Balm Medicated SPF 154.25 g in 1 CYLINDERSALVE4.256
10210-0023-2Carmex Classic Lip Balm Medicated SPF 153 in 1 PACKAGESALVE36
10210-0023-2Carmex Classic Lip Balm Medicated SPF 154.25 g in 1 CYLINDERSALVE4.256
10210-0023-3Carmex Classic Lip Balm Medicated SPF 151 in 1 CARTONSALVE16
10210-0023-3Carmex Classic Lip Balm Medicated SPF 154.25 g in 1 CYLINDERSALVE4.256
10210-0023-4Carmex Classic Lip Balm Medicated SPF 154 in 1 TRAYSALVE46
10210-0023-4Carmex Classic Lip Balm Medicated SPF 154.25 g in 1 CYLINDERSALVE4.256
10210-0023-5Carmex Classic Lip Balm Medicated SPF 154.25 g in 1 CYLINDERSALVE4.256
10210-0023-5Carmex Classic Lip Balm Medicated SPF 1524 in 1 BOXSALVE246
10210-0023-1Carmex 10 Count Variety Pack SPF 15 Sunscreen4.25 g in 1 CYLINDERSALVE12.75 g7.5 g in 100g3
10210-0023-1Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 154.25 g in 1 CYLINDERSALVE12.75 g7.5 g in 100g2
10210-0023-1Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 154.25 g in 1 CYLINDERSALVE29.75 g4 g in 100g1
10210-0023-1Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 154.25 g in 1 CYLINDERSALVE12.75 g35 g in 100g1
10210-0023-1Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 154.25 g in 1 CYLINDERSALVE8.5 g7.5 g in 100g1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10210-0023CARMEX CLASSIC LIP BALM MEDICATED SPF 15 (OCTINOXATE, OXYBENZONE, PETROLATUM) SALVE [CARMA LABORATORIES, INC.]6Current NDC, Legacy NDC, 9 package rows20231026_ca20b2dc-97e5-461a-94c8-5c109cd15285.zip
10210-0023CARMEX 10 COUNT VARIETY PACK SPF 15 SUNSCREEN (OCTINOXATE, OXYBENZONE, PETROLATUM) KIT [CARMA LABORATORIES, INC.]3Current NDC, Legacy NDC20231026_bacc60ec-0b6a-4ba2-b246-a59694f06b77.zip
10210-0023CARMEX CLASSIC LIP BALM MEDICATED FREE CUPCAKE BATTER STICK SUNSCREEN SPF 15 (OCTINOXATE, OXYBENZONE, WHITE PETROLATUM) KIT [CARMA LABORATORIES, INC.]2Current NDC, Legacy NDC20231026_5720bd35-de4a-4db4-a4df-0fbc59719bfd.zip
10210-0023CARMEX VARIETY PACK CLASSIC MEDICATED LIP BALM LIP BALM SPF 15 (CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]1Current NDC, Legacy NDC20250402_3a36a241-37a9-445a-a6e0-97709a7457a8.zip
10210-0023CARMEX VARIETY PACK CLASSIC MEDICATED LIP BALM LIP BALM SPF 15 (CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]1Current NDC, Legacy NDC20250402_3a3af6e1-0281-462e-85e7-144cc5d46f32.zip
10210-0023CARMEX VARIETY PACK CLASSIC MEDICATED LIP BALM LIP BALM SPF 15 (CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE) KIT [CARMA LABORATORIES, INC.]1Current NDC, Legacy NDC20250402_c04059e9-8175-46c2-8582-f84ef193abd3.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 54 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATENice-Pak Products, LLCaf052521-bfa6-4142-a10b-ef51f474a0772026-03-13Warnings, Adverse reactionsExact identifier
application number: M020
Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATENice-Pak Products, LLC42647444-93a3-4d2c-9bfc-91621fd098f72026-03-13Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Babies SPF 50AVOBENZONE, HOMOSALATE, OCTISALATENice-Pak Products, LLCa4b9d7c0-dc09-4f0e-8b65-90ba180552bf2026-03-13Warnings, Adverse reactionsExact identifier
application number: M020
TINTED WATERY SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEKSISTERS PTE. LTD.4ced53d0-8bfc-ff8e-e063-6294a90a9dbd2026-03-13WarningsExact identifier
application number: M020
Round Lab Birch Juice Mother s Day Gift SetAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.4cf03092-7886-ffa1-e063-6294a90a2aad2026-03-13WarningsExact identifier
application number: M020
Daily Moisturizing Mineral SunscreenBROAD SPECTRUM SPF30EDINA PLASTIC SURGERY,LTD.4d056e2b-5813-da42-e063-6294a90ac5192026-03-13WarningsExact identifier
application number: M020
La Roche Posay Anthelios Sunscreen SPF 60 Ultra lightAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEL'Oreal USA, Inc.dad00eee-92cd-7610-e053-2a95a90a1fac2026-03-13WarningsExact identifier
application number: M020
VITARAN REJUVENA SUNCAREALLANTOIN, AVOBENZONE, HOMOSALATE, OCTISALATEBR PHARM CO. , Ltd.4cb7af72-49f6-0738-e063-6394a90a79eb2026-03-12WarningsExact identifier
application number: M020
MIZON SNAIL REPAIR INTENSIVE BB No. 21ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4cd0a8a7-11aa-e168-e063-6394a90a2ff22026-03-12WarningsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEVi-Jon, LLC3da4706e-7c1a-435e-9603-e9aa984320182026-03-12Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENice-Pak Products, LLC53806657-7b4d-45ff-a75b-9340dcd8140e2026-03-12Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENice-Pak Products, LLC08237b4c-4e5c-4b12-9510-2f8d64ab7f3a2026-03-12Warnings, Adverse reactionsExact identifier
application number: M020
SunnyDays Broad Spectrum SPF 30 Tinted Sunscreen 5 FairfaxZINC OXIDETower 28108851ac-3812-4c02-a04a-9f9a7f529ed62026-03-12WarningsExact identifier
application number: M020
DIY Booster SPF 30 Facial Serum UnscentedOCTINOXATE, OCTISALATE, AVOBENZONE, AND ZINC OXIDEAndalou naturalsebaf5ef7-84aa-4cb1-a701-2e0d0fd357df2026-03-12WarningsExact identifier
application number: M020
Vacation SPF 50 ClassicAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVacation INC.f268fb1c-d7c2-f2f9-e053-2995a90a9e222026-03-12WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440CTITANIUM DIOXIDEKenvue Brands LLC4c335d9c-40ca-c0ce-e063-6394a90ac20a2026-03-11WarningsExact identifier
application number: M020
CENTELLA SUNSCREEN CreamZINC OXIDEYunqi Cosmetics (Shenzhen) Co., Ltd4cbac4e9-7540-f703-e063-6394a90ad8082026-03-11WarningsExact identifier
application number: M020
Vacation Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.4ba8ed52-2f52-40b9-a810-8450f9b907782026-03-10WarningsExact identifier
application number: M020
COOLA Zinc Oxide BodyLotion SPF 50 Fragrance-FreeZINC OXIDECOOLA LLC4cad89a5-325c-b3c2-e063-6294a90ac2252026-03-10WarningsExact identifier
application number: M020
Olay Complete plus Facial Moisturizer with Sunscreen Broad Spectrum SPF 40 SensitiveAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company4caf2ab5-76cb-4b0f-e063-6294a90a233e2026-03-10WarningsExact identifier
application number: M020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentPSN3a36a241-37a9-445a-a6e0-97709a7457a81
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentPSN3a3af6e1-0281-462e-85e7-144cc5d46f321
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentPSNc04059e9-8175-46c2-8582-f84ef193abd31
2475168camphor 0.017 MG/MG / petrolatum 0.453 MG/MG Topical OintmentSCD3a36a241-37a9-445a-a6e0-97709a7457a81
2475168camphor 0.017 MG/MG / petrolatum 0.453 MG/MG Topical OintmentSCD3a3af6e1-0281-462e-85e7-144cc5d46f321
2475168camphor 0.017 MG/MG / petrolatum 0.453 MG/MG Topical OintmentSCDc04059e9-8175-46c2-8582-f84ef193abd31
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentSY3a36a241-37a9-445a-a6e0-97709a7457a81
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentSY3a3af6e1-0281-462e-85e7-144cc5d46f321
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentSYc04059e9-8175-46c2-8582-f84ef193abd31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10210-0023-1102100023014.25 g in 1 CYLINDER (10210-0023-1) 4.25 g2016-09-260000-00-00NoNoCurrent
10210-0023-2102100023023 CYLINDER in 1 PACKAGE (10210-0023-2) / 4.25 g in 1 CYLINDER3 cylinder2016-09-260000-00-00NoNoCurrent
10210-0023-3102100023031 CYLINDER in 1 CARTON (10210-0023-3) / 4.25 g in 1 CYLINDER1 cylinder2016-09-260000-00-00NoNoCurrent
10210-0023-4102100023044 CYLINDER in 1 TRAY (10210-0023-4) / 4.25 g in 1 CYLINDER4 cylinder2016-09-260000-00-00NoNoCurrent
10210-0023-51021000230524 CYLINDER in 1 BOX (10210-0023-5) / 4.25 g in 1 CYLINDER24 cylinder2023-01-01NoNoCurrent