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 68 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Pink IceHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCea23616f-1d59-4e32-88bb-d035af7277282026-01-27WarningsExact identifier
application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Tropic TwistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC21b6239b-26d0-4b6b-8aee-fe1f20d8aaea2026-01-27WarningsExact identifier
application number: M020
Sugargirl Sun Gloss SPF 15 Tinted Lip Gloss Sunscreen Vanilla IcingHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC483b6873-fe58-4a38-bf82-df116617c5f02026-01-27WarningsExact identifier
application number: M020
Zinc Oxide 20%SUNSCREEN SPF 50 MINERALS&C Hampton Sun4960930e-a1bf-d850-e063-6294a90a40842026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen AmalfiCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN AMALFILE COSMETICS INC4963658b-59bb-b313-e063-6394a90a0a512026-01-27WarningsExact identifier
application number: M020
Golden Glow SHIMMER MISTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTD4963e513-d1fc-4b0e-e063-6394a90a7ddf2026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen RioCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN RIOLE COSMETICS INC49644002-153f-c254-e063-6394a90a46eb2026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen CaboCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CABOLE COSMETICS INC49643a56-3627-67f8-e063-6294a90a2d7b2026-01-27WarningsExact identifier
application number: M020
Ceile shade PROTECT Broad Spectrum SPF 45 Sunscreen CaymansCEILE SHADE PROTECT BROAD SPECTRUM SPF 45 SUNSCREEN CAYMANSLE COSMETICS INC49644002-153e-c254-e063-6394a90a46eb2026-01-27WarningsExact identifier
application number: M020
Hydrating Glow Mist with Pentavitin SPF 50 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTD496ba4c4-6577-88ff-e063-6294a90a09952026-01-27WarningsExact identifier
application number: M020
Vacation Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.b442530f-cae3-418b-9675-c188796538262026-01-27WarningsExact identifier
application number: M020
EltaMD UV Clear Blemish-Prone and Oil BalancingOCTINOXATE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6337b9e3-2524-4292-8fc8-1f6aad6cfe052026-01-27WarningsExact identifier
application number: M020
SPF Ginger Sunscreen SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENESPF GINGER LLCf303ad78-5fa3-40d1-9b1c-53ae1ca73aed2026-01-26WarningsExact identifier
application number: M020
ALOE UP COCO-MANGO SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC8506049f-cb43-4d1d-885b-c6d3a99bbba32026-01-26WarningsExact identifier
application number: M020
ALOE UP COCO-MANGO SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC144178e7-2df9-49c3-9667-43986cee89c42026-01-26WarningsExact identifier
application number: M020
ALOE KOTE SPF 25OCTINOXATE, OXYBENZONE, HOMOSALATEAloe Care International, LLC12e78c53-ba19-4c8e-bd2f-8c85fccbc1792026-01-26WarningsExact identifier
application number: M020
ALOE UP KIDS SPORT SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC62016e94-b5d2-4ba2-ab9c-b0b2c1ead6502026-01-26WarningsExact identifier
application number: M020
Homosalate 10 Avobenzone 3% Octocrylene 6%SPF 45 FACES&C Hampton Sun LLCe49808c9-5025-4965-8679-7fe824cf69072026-01-26WarningsExact identifier
application number: M020
ENVIRONMENTAL DEFENSEZINC OXIDEAvasol LLC1fbddab4-71f7-4167-ad21-30040b7c71bb2026-01-26WarningsExact identifier
application number: M020
Surfers BarrierZINC OXIDEAvasol LLCd6e2ac0a-3bf6-4d08-8647-6a23de2ac8572026-01-26WarningsExact 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