Label: TRILIPIDERM BROAD SPECTRUM SPF 30- butyl methoxydibenzoylmethane, ethylhexyl methoxycinnamate, homosalate, octocrylene cream

  • NDC Code(s): 60892-601-00, 60892-601-01, 60892-601-03, 60892-601-04, view more
    60892-601-05, 60892-601-08, 60892-601-32, 60892-601-64, 60892-601-77
  • Packager: TriLipid Research Institute, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 9, 2023

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  • Active Ingredients

    Butyl Methoxydibenzoylmethane 3%, Ethylhexyl Methoxycinnamate 7.5%, Homosalate 10%, Octocrylene 2.7%

  • 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

  • Stop Use and Ask a Doctor

    If Rash Occurs

  • 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
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Children under 6 months: ask a doctor
    • 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 10:00 AM – 2:00 PM
    • Wear long sleeved shirts, pants, hats, and sunglasses
  • Inactive Ingredients:

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua (Deionized Water), Butylene Glycol, Calendula Officinalis Extract, Carthamus Tinctorius (Safflower) Oil, Caprylyl Glycol, Ceteareth-20, Chamomilla Matricaria (Chamomile) Extract, Cholecalciferol (Vitamin B3), Crambe Abyssinica (Abyssinian) Oil, Dodecane, Gluconolactone, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Helianthus Annuus (Sunflower) Wax, Hexylene Glycol, Limnanthes Alba (Meadowfoam) Oil, Magnesium Aluminum Silicate, Meadowfoam Estolide, o-Cymen-5-ol, Olea Europeaea (Olive) Fruit Unsaponifiables, dl-Panthenol, Partum (Fragrance), Phenoxyethanol, Phytosterols, Polysorbate 20, Potassium Sorbate, Simmondsia Chinensis (Jojoba) Oil, Tocopherol (Vitamin E), Triethanolamine, Xanthan Gum.

  • Other Information

    • Protect this product from excessive heat and direct sun
  • SPL UNCLASSIFIED SECTION

    Made in the USA * Distributed by:

    Trilipid Research Institute LLC

    Jackson, WY 83002

  • PRINCIPAL DISPLAY PANEL

    All-Body Moisture Retention Creme Broad Spectrum SPF 30 Sample Image

  • INGREDIENTS AND APPEARANCE
    TRILIPIDERM  BROAD SPECTRUM SPF 30
    butyl methoxydibenzoylmethane, ethylhexyl methoxycinnamate, homosalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60892-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CHAMOMILE (UNII: FGL3685T2X)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    MEADOWFOAM ESTOLIDE (UNII: 3HH93SL2H9)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DODECANE (UNII: 11A386X1QH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    LIMNANTHES ALBA WHOLE (UNII: DKY81513ER)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CRAMBE HISPANICA SUBSP. ABYSSINICA WHOLE (UNII: 3885PD1IZ8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60892-601-641896 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/31/2014
    2NDC:60892-601-32948 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/31/2014
    3NDC:60892-601-041 in 1 BOX01/31/2014
    3NDC:60892-601-08237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    4NDC:60892-601-051 in 1 BOX12/13/2018
    4NDC:60892-601-0389 mL in 1 TUBE; Type 0: Not a Combination Product
    5NDC:60892-601-0129.625 mL in 1 TUBE; Type 0: Not a Combination Product01/31/2014
    6NDC:60892-601-009 mL in 1 PACKET; Type 0: Not a Combination Product01/31/2014
    7NDC:60892-601-774 mL in 1 PACKET; Type 0: Not a Combination Product12/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/31/2014
    Labeler - TriLipid Research Institute, LLC (013903326)
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