Label: SPF 25 LIP BALM- avobenzone, octisalate, homosalate paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 5, 2024

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  • Drug Facts

  • Active Ingredients

    Avobenzone 3.00%
    Octisalate 5.00%
    Homosalate 10.00%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • Warnings

    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.

    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 sweating • Immediately after towel • At least every 2 hours • After eating or drinking

    Sun Protection Measures
    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.

  • Inactive Ingredients

    Vegetable Oil, Bis-Diglyceryl Polyacyladipate-2, Candelillia (Euphorbia Cerifera) Wax, Sunflower (Helianthus Annuus) Seed Oil, Avocado (Persea Gratissima) Oil, Cocoa (Theobroma Cacao) Seed Butter, Shea (Butyrospermum Parkii) Butter, Peppermint (Mentha Piperita) Oil, Tocopherol, Menthol  

  • Other Information

    • Protect the product in this container from excessive heat and direct sun

  • Questions or comments?

    Call 1-888-DRMTLGY

  • SPL UNCLASSIFIED SECTION

    MEDICAL GRADE SKIN CARE

    Broad Spectrum SPF 25 Sunscreen

    A non-sticky SPF lip balm that protects, soothes, and relieves dry, chapped lips.

    Manufactured in USA

    DRMTLGY, LLC.
    Canoga Park, CA 91304
    www.DRMTLGY.com

    CRUELTY FREE 

    BACKED BY SCIENCE

    DERMATOLOGIST RECOMMENDED

  • Packaging

    LIPBALM-002

  • INGREDIENTS AND APPEARANCE
    SPF 25 LIP BALM 
    avobenzone, octisalate, homosalate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83286-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83286-002-011 in 1 CARTON01/18/2024
    17 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/18/2024
    Labeler - Drmtlgy, LLC (094762235)
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