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 82 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Blue Lizard Baby SPF 50ZINC OXIDECrown Laboratories9948f5b8-43bd-1c99-e053-2a95a90a61212026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sheer SPF 50 SunscreenZINC OXIDECrown Laboratories3368f1cb-c341-e886-e063-6394a90a9b7c2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sport SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories2f3844d8-0367-aad9-e063-6294a90a1fce2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sheer Face SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories30cd79da-2f25-a42a-e063-6394a90a83322026-01-12WarningsExact identifier
application number: M020
ACCOJE PROTECTIVE AIR-FIT MINERAL SUNSCREENTITAMIUN DIOXIDE, ZINC OXIDEUCL Co., Ltd.4837b4f6-ada9-801a-e063-6294a90a85472026-01-12WarningsExact identifier
application number: M020
Intellishade Original SPF 45OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe213a681-eb22-69c0-e053-2995a90a899e2026-01-12WarningsExact identifier
application number: M020
GINZING SPF 40 ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40 SHEER TINT RELEASEHOMOSALATE,OCTINOXATE,OCTISALATE, AND ZINC OXIDEORIGINS NATURAL RESOURCES INC.48393640-4b97-04de-e063-6294a90aa6a62026-01-12WarningsExact identifier
application number: M020
Hale and Hush Broad Spectrum SPF 30 SPF 30ZINC OXIDEEclectic Solutions LLC0530904f-b02c-d8cf-e063-6294a90aa5a72026-01-12WarningsExact identifier
application number: M020
Minori Daily Mineral Face Sunscreen Broad Spectrum SPF 30ZINC OXIDEMinori Inc.1d4e2654-1638-0d01-e063-6394a90af3032026-01-12WarningsExact identifier
application number: M020
LUXURY BODY RITUAL HYDRATING SPF 30ZINC OXIDEJANE STREET LLC15e9d688-f226-1a19-e063-6394a90ab9062026-01-12WarningsExact identifier
application number: M020
BROAD SPECTRUM SPF50 SPF 50AVOBENZONE, HOMOSALATE OCTISALATE,NAKED SUNDAYS PTY LTD0426b1e9-063b-c1e6-e063-6294a90a25542026-01-11WarningsExact identifier
application number: M020
SPF30 MINERAL SUNSCREEN MOUSSEZINC OXIDEAopline Biotechnology (Guangzhou) Co., Ltd.48031a0f-c2ed-5424-e063-6294a90ad0ff2026-01-10WarningsExact identifier
application number: M020
SPF 30 MINERAL WHIPPED CREAMS SHIMMERZINC OXIDEAopline Biotechnology (Guangzhou) Co., Ltd.48037a05-722e-4231-e063-6294a90ac51f2026-01-10WarningsExact identifier
application number: M020
ODLUMIVIE Tinted Mineral SunscreenZINC OXIDE,TITANIUM DIOXIDEGuangzhou Meijiao Medical Biotechnology Co., Ltd.480d6e65-f6dc-d2a5-e063-6294a90a24a12026-01-10WarningsExact identifier
application number: M020
Cloud Brush On Sunscreen Clear Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFUTURE 8 LLC9922f132-f6a5-41ca-847a-936b20bf17162026-01-09WarningsExact identifier
application number: M020
Sunscreen Lotion118mLZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd46355437-4068-9d03-e063-6394a90ae52c2026-01-09WarningsExact identifier
application number: M020
ST MORIZ SUNCARE FACE SUNSCREEN SPF30SUNCARE FACE SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.47f26af6-4d02-3506-e063-6294a90a0fe62026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Sun 6 SPF Tan and Care CarrotOCTINOXATEFarmasi US LLC67de9257-70f3-4444-a4a2-a8d7425fcc0e2026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Sunscreen SPF30 Broad SpectrumAVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATEFarmasi US LLCd9197dce-20a3-4d10-807c-ec84ab9021652026-01-09WarningsExact identifier
application number: M020
Dr. C. Tuna Lumi Radiance BrighteningOCTOCRYLENE, OCTINOXATE, AVOBENZONEFarmasi US LLCadf5621b-7cf0-53b3-e053-2a95a90a80582026-01-09WarningsExact 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