Label: CARMEX CLASSIC LIP BALM MEDICATED FREE CUPCAKE BATTER STICK SUNSCREEN SPF 15- octinoxate, oxybenzone, white petrolatum kit

  • NDC Code(s): 10210-0023-1, 10210-0030-1, 10210-0059-1
  • Packager: Carma Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

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 of age: ask a doctor

  • Other Information

    • this is 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

  • Drug Facts

  • Active Ingredients

    Octinoxate 7.50%

    Oxybenzone 4.00%

    Purpose

    Sunscreen

  • Uses

    • helps protect against sunburn
    • 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, skin cancer or early skin aging. Skin Cancer/Skin Aging Alert:not

    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: • 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

  • Other Information

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

    • protect this product from excessive heat and direct sun

  • Inactive Ingredients

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

  • Package Labeling:

    Label3

  • INGREDIENTS AND APPEARANCE
    CARMEX CLASSIC LIP BALM MEDICATED FREE CUPCAKE BATTER STICK SUNSCREEN SPF 15 
    octinoxate, oxybenzone, white petrolatum kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10210-0059
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10210-0059-11 in 1 BLISTER PACK01/01/2023
    11 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 13 CYLINDER 12.75 g
    Part 21 CYLINDER 4.25 g
    Part 1 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) (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)  
    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)  
    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 DrugM02001/01/2023
    Part 2 of 2
    CARMEX DAILY CARE MOISTURIZING LIP BALM CUPCAKE BATTER SPF 15 
    octinoxate, oxybenzone salve
    Product Information
    Item Code (Source)NDC:10210-0030
    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)  
    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:10210-0030-14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2023
    Labeler - Carma Laboratories, Inc. (006090153)
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