Label: CARMEX DAILY CARE MOISTURIZING LIP BALM HOLIDAY SPF 15- octinoxate, oxybenzone kit

  • NDC Code(s): 10210-0033-1, 10210-0049-1, 10210-0050-1, 10210-0051-1, view more
    10210-0052-1
  • 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%

    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, 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: • 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 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

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

  • 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, 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: • 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 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

    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:10210-0049-1

    Kit

  • Package Labeling:10210-0050-1

    Label

  • Package Labeling:10210-0051-1

    label4

  • Package Labeling:10210-0052-1

    Label2

  • Package Labeling:10210-0033-1

    Label3

  • INGREDIENTS AND APPEARANCE
    CARMEX DAILY CARE MOISTURIZING LIP BALM HOLIDAY SPF 15 
    octinoxate, oxybenzone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10210-0049
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10210-0049-11 in 1 KIT01/31/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 CYLINDER 4.25 g
    Part 21 CYLINDER 4.25 g
    Part 31 CYLINDER 4.25 g
    Part 41 CYLINDER 4.25 g
    Part 1 of 4
    CARMEX DAILY CARE MOISTURIZING LIP BALM MERRY BERRY SPF 15 
    octinoxate, oxybenzone salve
    Product Information
    Item Code (Source)NDC:10210-0050
    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:10210-0050-14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/31/2019
    Part 2 of 4
    CARMEX DAILY CARE MOISTURIZING LIP BALM SUGAR PLUM SPF 15 
    octinoxate, oxybenzone salve
    Product Information
    Item Code (Source)NDC:10210-0051
    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:10210-0051-14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/31/2019
    Part 3 of 4
    CARMEX DAILY CARE MOISTURIZING LIP BALM VANILLA ICING SPF 15 
    octinoxate, oxybenzone salve
    Product Information
    Item Code (Source)NDC:10210-0052
    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)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10210-0052-14.25 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/31/2019
    Part 4 of 4
    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)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    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 DrugM02001/31/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/31/2019
    Labeler - Carma Laboratories, Inc. (006090153)
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