Label: CARMEX VARIETY PACK CLASSIC MEDICATED LIP BALM LIP BALM SPF 15 (camphor- synthetic, white petrolatum, octinoxate, oxybenzone kit

  • NDC Code(s): 10210-0022-6, 10210-0023-1, 10210-0088-1
  • Packager: Carma Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 19, 2025

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  • Drug Facts

  • Active ingredients

    Camphor 1.70%

    White Petrolatum 45.30%

    Purpose

    External Analgesic

    Lip Protectant

  • Uses

    • helps provide relief of symptoms of cold sores and dry lips
  • Warnings

    For external use only

    When using this product:

    keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if:

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Do not use

    • deep puncture wounds 
    • serious burns
    • animal bites

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply to lips not more than 3 to 4 times daily

    • children under 2 years of age: ask a doctor 

  • Other information

    • this is a personal care item, and should be used by one individual only

  • Inactive ingredients 

    lanolin, beeswax, cetyl esters, paraffinum liquidum, theobroma cacao seed butter, menthol, salicylic acid, phenol, vanillin, flavor

  • Drug Facts

  • Active ingredients

    Octinoxate 7.50%

    Oxybenzone 4.00%

    White Petrolatum 35.00%

    Purpose

    Sunscreen

    Lip Protectant

  • Uses

    • helps protect against sunburn and chapped lips
    • higher SPF gives more sunburn protection
  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    For external use only

    Do not use

    on damaged or broken skin

    When using this product:

    keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if:

    rash occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure

    • reapply: • at least every 2 hours

    • children under 2 years of age: ask a doctor

  • Other information

    • this is a personal care item, and should be used by one individual only

    • protect this product from excessive heat and direct sun

    • do not use if safety seal is broken prior to purchase

  • Inactive ingredients

    lanolin, theobroma cacao seed butter, euphorbia cerifera cera, beeswax, cetyl esters, ozokerite, paraffin, limnanthes alba seed oil, camphor, menthol, salicylic acid, phenol, flavor, vanillin

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    CARMEX VARIETY PACK CLASSIC MEDICATED LIP BALM LIP BALM SPF 15 
    camphor (synthetic), white petrolatum, octinoxate, oxybenzone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10210-0088
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10210-0088-11 in 1 KIT04/01/2025
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 17 TUBE 70 g
    Part 22 CYLINDER 8.5 g
    Part 1 of 2
    CARMEX CLASSIC LIP BALM MEDICATED 
    camphor (synthetic), petrolatum salve
    Product Information
    Item Code (Source)NDC:10210-0022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1.7 g  in 100 g
    WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4) WHITE PETROLATUM45.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCOA BUTTER (UNII: 512OYT1CRR)  
    LANOLIN (UNII: 7EV65EAW6H)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    PHENOL (UNII: 339NCG44TV)  
    VANILLIN (UNII: CHI530446X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10210-0022-610 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/01/2025
    Part 2 of 2
    CARMEX CLASSIC LIP BALM MEDICATED SPF 15 
    octinoxate, oxybenzone, petrolatum salve
    Product Information
    Item Code (Source)NDC:10210-0023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (ETHYLHEXYL METHOXYCINNAMATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (BENZOPHENONE-3 - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 g
    WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4) WHITE PETROLATUM35 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    PHENOL (UNII: 339NCG44TV)  
    VANILLIN (UNII: CHI530446X)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10210-0023-14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/01/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/01/2025
    Labeler - Carma Laboratories, Inc. (006090153)
    Establishment
    NameAddressID/FEIBusiness Operations
    Carma Laboratories, Inc.006090153manufacture(10210-0088, 10210-0022, 10210-0023)
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