Label: CARMEX CLASSIC LIP BALM MEDICATED FREE WINTERGREEN STICK (octinoxate, oxybenzone, camphor- synthetic, white petrolatum kit

  • NDC Code(s): 10210-0033-1, 10210-0038-0, 10210-0047-1
  • Packager: Carma Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 8, 2023

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  • Drug Facts

  • Active Ingredients

    Octinoxate 7.50%

    Oxybenzone 4.00%

  • Uses

    • helps protect against sunburn
    • 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.

    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: • after 80 minutes of swimming or sweating • immediately after towel drying
    • at least every 2 hours
    • children under 2 years of age: ask a doctor

  • Inactive Ingredients

    petrolatum, lanolin, euphorbia cerifera (candelilla) wax, isopropyl palmitate, ozokerite, beeswax, cetyl esters, paraffin, theobroma cacao (cocoa) seed butter, flavor, limnanthes alba (meadowfoam) seed oil, stevia rebaudiana extract

  • 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

    When using this product:

    keep out of eyes.

    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 on:

    • 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

  • Inactive Ingredients

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

  • Package Labeling:10210-0047-1

    Kit

  • Package labeling:10210-0038-0

    tube

  • Package Labeling:10210-0033-1

    Box

  • INGREDIENTS AND APPEARANCE
    CARMEX CLASSIC LIP BALM MEDICATED FREE WINTERGREEN STICK 
    octinoxate, oxybenzone, camphor (synthetic), white petrolatum kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10210-0047
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10210-0047-11 in 1 KIT06/20/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 CYLINDER 4.25 g
    Part 21 TUBE 10 g
    Part 1 of 2
    CARMEX DAILY CARE MOISTURIZING LIP BALM WINTERGREEN SPF 15 
    octinoxate, oxybenzone salve
    Product Information
    Item Code (Source)NDC:10210-0033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CERESIN (UNII: Q1LS2UJO3A)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10210-0033-14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/20/2018
    Part 2 of 2
    CARMEX CLASSIC LIP BALM MEDICATED 
    camphor (synthetic), white petrolatum salve
    Product Information
    Item Code (Source)NDC:10210-0038
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)17 mg  in 1 g
    WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4) WHITE PETROLATUM453 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    MENTHOL (UNII: L7T10EIP3A)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    PHENOL (UNII: 339NCG44TV)  
    VANILLIN (UNII: CHI530446X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10210-0038-010 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/20/2018
    Labeler - Carma Laboratories, Inc. (006090153)
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