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

  • NDC Code(s): 10210-0029-1, 10210-0032-1, 10210-0037-1, 10210-0042-1
  • 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 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, 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: 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, beeswax,cetyl esters, flavor, isopropyl palmitate, theobroma cacao seed butter, limnanthes alba seed oil, polypropylene, isohexadecane, polyamide8 ,polyhydroxystearic acds, stevia rebaudiana extract. Wintergreen:

  • Drug Facts

  • Active Ingredients

    Octinoxate 7.50%

    Oxybenzone 4.00%

    Purpose

    Sunscreen

  • 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.

    For external use only

    Do not use

    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

    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: 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, beeswax,cetyl esters, flavor, isopropyl palmitate, theobroma cacao seed butter, limnanthes alba seed oil, polypropylene, isohexadecane, polyamide8 ,polyhydroxystearic acid, stevia rebaudiana extract. Fresh Cherry,Strawberry:

  • Package labeling:

    card

    tray

  • Package Labeling:10210-0029-1

    label4

  • Package Labeling: 10210-0032-1

    Bottle11

  • Package Labeling: 10210-0033-2

    Bottle15

  • INGREDIENTS AND APPEARANCE
    CARMEX DAILY CARE MOISTURIZING LIP BALM SPF 15 ASSORTED 
    octinoxate, oxybenzone kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10210-0042
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10210-0042-11 in 1 KIT01/31/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 10 g
    Part 22 TUBE 20 g
    Part 31 TUBE 10 g
    Part 1 of 3
    CARMEX DAILY CARE MOISTURIZING LIP BALM FRESH CHERRY SPF 15 
    octinoxate, oxybenzone salve
    Product Information
    Item Code (Source)NDC:10210-0029
    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)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10210-0029-110 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/20/2019
    Part 2 of 3
    CARMEX DAILY CARE MOISTURIZING LIP BALM STRAWBERRY SPF 15 
    octinoxate, oxybenzone salve
    Product Information
    Item Code (Source)NDC:10210-0032
    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)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10210-0032-110 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/12/2017
    Part 3 of 3
    CARMEX DAILY CARE MOISTURIZING LIP BALM WINTERGREEN SPF 15 
    octinoxate, oxybenzone salve
    Product Information
    Item Code (Source)NDC:10210-0037
    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
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CERESIN (UNII: Q1LS2UJO3A)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10210-0037-110 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/31/2020
    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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