Label: CARMEX CLASSIC LIP BALM MEDICATED SPF15 TRIPLE FORCE FORMULA- octinoxate, oxybenzone, white petrolatum salve

  • NDC Code(s): 10210-0066-1
  • Packager: Carma Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 2, 2024

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  • Drug Facts

  • Active ingredients

    Octinoxate 7.50%
    Oxybenzone 4.00%
    White Petrolatum 35.00%

    Purpose

    Sunscreen

    Suncreen

    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
  • 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

  • 10210-0066-1

    packageLabel1.jpg

  • INGREDIENTS AND APPEARANCE
    CARMEX CLASSIC LIP BALM MEDICATED SPF15 TRIPLE FORCE FORMULA 
    octinoxate, oxybenzone, white petrolatum salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10210-0066
    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
    WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4) WHITE PETROLATUM350 mg  in 1 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 (UNII: L7T10EIP3A)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    PHENOL (UNII: 339NCG44TV)  
    VANILLIN (UNII: CHI530446X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10210-0066-12 in 1 BLISTER PACK01/01/2023
    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 DrugM01601/01/2023
    Labeler - Carma Laboratories, Inc. (006090153)
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