Label: MEDICATED LIP BALM- dimethicone, oxybenzone, and 2-ethylhexyl dimethyl paba cream

  • NDC Code(s): 74553-004-01
  • Packager: Xtreme Tools International, Inc
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 16, 2020

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  • Active ingredients

    Dimethicone 2.0%

    Oxybenzone 2.5%

    2-Ethylhexyl Dimethyl PABA 6.6%

  • Purpose

    Dimethicone 2.0% - Lip protectant

    Oxybenzone 2.5%- Sunscreen

    2-Ethylhexyl Dimethyl PABA 6.6%- Sunscreen

  • Uses

    • Temporarily protects and relieve chapped or cracked lips
    • Helps prevent sunburn
  • 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

    Do not use on broken or damaged skin.

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    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
    • use a water resistant sunscreen if swimming or sweating
    • children under 6 years of age: Ask a doctor
  • Inactive ingredients

    Prunus Arnygdalus Dulcis (Sweet Almond) Oil, Anthemis Nobilis Flower Extract, Hydrogenated Vegetable Oil, Beeswax, Shea Butter Ethyl Esters, Cocos Nucifera (Coconut) Oil, Argania Spinosa (Argan) Nut Oil, Tocopheryl Acetate, Organic flavors.

  • Other information

    • protect this product from excessive heat and direct sun.
  • Questions or comments?

    Call 1-305-622-7474 Monday through Friday 9:00 AM to 5:00 PM

  • PACKAGE LABEL

    5 gram in Jar ; NDC 74553-004-01

    LIPBALM

  • INGREDIENTS AND APPEARANCE
    MEDICATED LIP BALM 
    dimethicone, oxybenzone, and 2-ethylhexyl dimethyl paba cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74553-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.5 g  in 100 g
    PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O6.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALMOND OIL (UNII: 66YXD4DKO9)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74553-004-015 g in 1 JAR; Type 0: Not a Combination Product10/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/14/2020
    Labeler - Xtreme Tools International, Inc (125398904)
    Registrant - Xtreme Tools International, Inc (125398904)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xtreme Tools International, Inc125398904manufacture(74553-004)
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