Label: DR. C. TUNA SUN PROTECTOR LIP BALM SPF 15- homosalate, octinoxate cream

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

Drug Label Information

Updated December 9, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts:

  • Active Ingredients:

    Homosalate 4,45 %

    Ethylhexyl Methoxycinnamate 3,45 %

    Purpose:

    Sunscreen

  • Uses:

    • Helps prevent sunburn.
  • Warnings:

    For external use only.

    Do not use 

    on damaged or broken skin.

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    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. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Protects against UVB and UVA rays. This product does not provide 100% protection. Use physical protection (hat, t-shirt, glasses, etc.) Avoid long periods of sun exposure even if you are using sun protection. Keep babies and young children out of direct sunlight. The excessive sun exposure is a major health risk, Discontinue use if signs of irritation or rash occur. Aovid contact with eyes, may cause irritation. 

  • Directions:

    Apply liberally 15 minutes before sun exposure - reapply at least every two hours. Apply morning and night, and as often as needed during the day. Reapply frequently on sun-centric days, and adventures. Children under 6 months of age: Ask a doctor. Apply before sun exposure. To maintain protection, apply frequently, especially after sweating, swimming or drying off. Apply sufficient amount to the skin. Sun Protection Measures:

  • Other information:

    Protect this product from excessive heat and direct sun.

  • Inactive Ingredients:

    Polyisoprene, C18-70 Isoalkane, Caprylic/Capric Triglyceride, Olus Oil, Synthetic Beeswax, Ceresin, Cetyl Alcohol, Di-C12-15 Alkyl Fumarate, Butyrospermum Parkii Butter, Silica, Aroma/Flavour, Tocopheryl Acetate.

  • Questions or Comments?

    info@farmasius.com (833) 432-7627 Monday - Friday (9 a.m. -9 p.m. EST)

  • Package Labeling: Dr. C. TUNA SUN PROTECTOR LIP BALM SPF 15, 15ml/0.5fl.oz

    Label01

  • INGREDIENTS AND APPEARANCE
    DR. C. TUNA SUN PROTECTOR LIP BALM SPF 15 
    homosalate, octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74690-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE44.5 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE34.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    CERESIN (UNII: Q1LS2UJO3A)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74690-030-001 in 1 BOX01/05/2022
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/05/2022
    Labeler - FARMASI US LLC (113303351)