FDA.reportPublic FDA data

Carmex Classic Lip Balm Medicated SPF15 Triple Force Formula

Product NDC
10210-0066
11-digit product format
102100066
Labeler code
10210
Product ID
10210-0066_152046a4-b208-8305-e063-6294a90aa7e2
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OXYBENZONE, WHITE PETROLATUM
Dosage form
SALVE
Route
TOPICAL
Labeler
Carma Laboratories, Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-01
Substance
OCTINOXATE; OXYBENZONE; WHITE PETROLATUM
Active strength
75; 40; 350 mg/g; 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 Classic Lip Balm Medicated SPF15 Triple Force Formula
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE75 mg/g
OXYBENZONE40 mg/g
WHITE PETROLATUM350 mg/g

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
3eb0f8ff-89e7-4410-8573-3349e4946548Available 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
10210-0066-1Carmex Classic Lip Balm Medicated SPF15 Triple Force Formula2 in 1 BLISTER PACKSALVE21
10210-0066-1Carmex Classic Lip Balm Medicated SPF15 Triple Force Formula4.25 g in 1 CYLINDERSALVE4.251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10210-0066CARMEX CLASSIC LIP BALM MEDICATED SPF15 TRIPLE FORCE FORMULA (OCTINOXATE, OXYBENZONE, WHITE PETROLATUM) SALVE [CARMA LABORATORIES, INC.]1Current NDC, 2 package rows20240403_3eb0f8ff-89e7-4410-8573-3349e4946548.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 43 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Juicy PeachCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company30b20bd5-3b4f-8cc7-e063-6394a90a91062025-03-19WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh StrawberryCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company30b2744d-fb59-f383-e063-6294a90abd2a2025-03-19WarningsExact identifier
application number: M016
Dr. Butler Hemorrhoid and PerinealMINERAL OIL 59.8%,PETROLATUM 36%Beyond Health P.A.d17b6f16-6893-ce0a-e053-2a95a90aa23a2025-03-19WarningsExact identifier
application number: M016
Gold Bond Diabetics Medicated Dry Skin Relief Foot CreamDIMETHICONE, WHITE PETROLATUMChattem, Inc.b951d1cb-b81e-4d7f-9a67-8405daa896672025-03-19WarningsExact identifier
application number: M016
Gold Bond Eczema Relief Medicated Hand CreamCOLLOIDAL OATMEALChattem, Inc.27457bc5-3edc-4c8b-b8a2-eaf09b511cf82025-03-19WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD30a977c3-6862-670e-e063-6294a90aeb2f2025-03-18WarningsExact identifier
application number: M016
YVTYVT Copper Peptides Face SerumCOPPER TRIPEPTIDE-1Beijing JUNGE Technology Co., Ltd.306f2d48-43b8-359a-e063-6394a90a06dc2025-03-16Boxed warning, WarningsExact identifier
application number: M016
Dr Talbots Cooling Perineal PadWATER, ALOE BARBADENSIS LEAF JUICE, BIOFLAVONOIDS, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CITRIC ACID, DECYL GLUCOSIDE, GLYCERIN, LACTIC ACID, LEVULINIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, SODIUM COCOAMPHOACETATE, POTASSIUM SORBATETalbot's Pharmaceuticals family Products, LLC.242277e2-ff26-ad4e-e063-6394a90ab3172025-03-14WarningsExact identifier
application number: M016
RID Poison Ivy Rash ReliefCALAMINE AND ZINC OXIDEOystershell Consumer Health Inc.36c3af9a-2646-4427-e063-6394a90a2c5e2025-03-13WarningsExact identifier
application number: M016
Aavini Double Layer Brightening Spot Correcting Essence OilAAVINI DOUBLE LAYER BRIGHTENING SPOT CORRECTING ESSENCE OILQingyuan Moksha Biotechnology Co., Ltd.2ff89a13-3969-2df1-e063-6394a90ac0d32025-03-10WarningsExact identifier
application number: M016
5% Signature Numb cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3008bbeb-abba-5cdb-e063-6294a90ae4832025-03-10WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Cucumber MelonCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company2fc4745c-fac9-7861-e063-6294a90a3f142025-03-07WarningsExact identifier
application number: M016
AD Skin ProtectantAD SKIN PROTECTANTWellSpring Pharmaceutical Corporationd26f1312-2e1b-4106-bc48-a336d4e034ad2025-03-07WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy Nighttime BalmOATMEALKenvue Brands LLC04d90e45-c2ee-4122-b919-a0eb6d11b59a2025-03-04WarningsExact identifier
application number: M016
5% Signature Numb cream5% SIGNATUREShengnan (Guangzhou) Cosmetics Co., LTD2f80abc0-49d8-968d-e063-6294a90a555b2025-03-04WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant VanillaCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companyf19b3056-063c-63ec-e053-2995a90a46142025-03-04WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Peppermint TwistCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company2770424d-7414-66d4-e063-6394a90ad4b12025-03-04WarningsExact identifier
application number: M016
Olay Sensitive Soothing Moisturizer Skin Protectant Fragrance-FreeCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company026bb3a1-3e01-1530-e063-6294a90ab1b12025-03-04WarningsExact identifier
application number: M016
5% Dr.care Numb creamLIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD2f905d76-ef9c-c844-e063-6394a90a4dc92025-03-04WarningsExact identifier
application number: M016
Desitin Maximum Strength Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLC1590101a-c968-fca5-e063-6394a90a7ccc2025-02-28WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10210-0066-1102100066012 CYLINDER in 1 BLISTER PACK (10210-0066-1) / 4.25 g in 1 CYLINDER2 cylinder2023-01-01NoNoCurrent