Label: FIRMARINE MOISTURIZER SPF 30- avobenzone, octinoxate, and octisalate lotion

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

Drug Label Information

Updated December 7, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%

  • 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 useon damaged or broken skin.

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

    Stop use and ask a doctorif rash occurs.

    Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control center right away.

  • Directions

    Apply liberally 15 minutes before sun exposure

    • reapply: after 40 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • 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 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-sleeve shirts, pants, hats, and sunglasses
      • children under 6 months: Ask a doctor
  • Inactive Ingredients

    Water, Butylene Glycol, Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Glycerin, Simmondsia Chinensis (Jojoba) Seed Oil, Glyceryl Stearate, Cetearyl Alcohol, Behenyl Alcohol, Palmitic Acid, Stearic Acid, Lecithin, Lauryl Alcohol, Cetyl Alcohol, Myristyl Alcohol, Coco-Glucoside, Ethylhexylglycerin, Dimethicone, PEG-100 Stearate, Spirulina Maxima Extract, Cucumis Sativus (Cucumber) Fruit Extract, Camellia Sinensis Leaf Extract, Phospholipids, Tocopheryl Acetate, Retinyl Palmitate, Ascorbyl Palmitate, Algae Extract, Pullulan, Sodium Hyaluronate, Trifluoroacetyl Tripeptide-2, Sea Water, Carbomer, Dextran, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Disodium EDTA, O-Cymen-5-Ol, Phenoxyethanol, Fragrance, Blue 1, Ext Violet 2.

  • Other information

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

    Call toll free at 866-452-7956.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED IN U.S.A. BY ERNO LASZLO NEW YORK, NY 10001

  • Product label

    image description
  • INGREDIENTS AND APPEARANCE
    FIRMARINE MOISTURIZER SPF 30 
    avobenzone, octinoxate, and octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57913-2833
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LAURYL ALCOHOL (UNII: 178A96NLP2)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)  
    CUCUMBER (UNII: YY7C30VXJT)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57913-2833-01 in 1 CARTON04/10/2013
    150 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/10/2013
    Labeler - Erno Laszlo, Inc. (098821031)
    Establishment
    NameAddressID/FEIBusiness Operations
    Mana Products078870292manufacture(57913-2833)
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