Label: CARMEX CLASSIC LIP BALM MEDICATED SPF 15- octinoxate, oxybenzone, petrolatum salve

  • NDC Code(s): 10210-0023-1, 10210-0023-2, 10210-0023-3, 10210-0023-4, view more
    10210-0023-5
  • Packager: Carma Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 25, 2023

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  • 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

     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. Skin Cancer/Skin Aging Alert:

    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: 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 wax, beeswax, cetyl esters, ozokerite, paraffin, limnanthes alba seed oil, camphor, menthol, salicylic acid, phenol, flavor, vanillin

  • Package Labeling:10210-0023-1

    Medicated SPF

  • Package Labeling: 10210-0023-4

    Label

  • Package Labeling:10210-0023-5

    Label02

  • INGREDIENTS AND APPEARANCE
    CARMEX CLASSIC LIP BALM MEDICATED SPF 15 
    octinoxate, oxybenzone, petrolatum salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10210-0023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - 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)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    MENTHOL (UNII: L7T10EIP3A)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    PHENOL (UNII: 339NCG44TV)  
    VANILLIN (UNII: CHI530446X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10210-0023-14.25 g in 1 CYLINDER; Type 0: Not a Combination Product09/26/2016
    2NDC:10210-0023-23 in 1 PACKAGE09/26/2016
    24.25 g in 1 CYLINDER; Type 0: Not a Combination Product
    3NDC:10210-0023-31 in 1 CARTON09/26/2016
    34.25 g in 1 CYLINDER; Type 0: Not a Combination Product
    4NDC:10210-0023-44 in 1 TRAY09/26/2016
    44.25 g in 1 CYLINDER; Type 0: Not a Combination Product
    5NDC:10210-0023-524 in 1 BOX01/01/2023
    54.25 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/26/2016
    Labeler - Carma Laboratories, Inc. (006090153)
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