Label: LAMUSE RETURN 2 BLESSING VISUAL BALM- titanium dioxide, octinoxate, octisalate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 March 15, 2018

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

  • ACTIVE INGREDIENT

    Active ingredients: Titanium Dioxide 9.12%, Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 4.00%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Inactive ingredients: Myrothamnus Flabellifolia Callus Culture Extract, Dimethicone, Dipropylene Glycol, Isoamyl p-Methoxycinnamate, Niacinamide, 1,2-Hexanediol, Cetyl PEG/PPG-10/1 Dimethicone, Water, Sodium Chloride, Beeswax, Hydroxyacetophenone, CI 77492, Diisostearyl Malate, Centella Asiatica Extract, Scutellaria Baicalensis Root Extract, Sorbitan Sesquioleate, CI 77491, Chamomilla Recutita (Matricaria) Flower Extract, Fragrance, Butylene Glycol, Sodium Citrate, Glyceryl Caprylate, CI 77499, Ethylhexylglycerin, Glycerin, Adenosine, Disodium EDTA, Triethoxycaprylylsilane, Macadamia Ternifolia Seed Oil, Hydrogenated Lecithin, Cholesterol, Aluminum Hydroxide, Mica, Polymethyl Methacrylate, Rose Extract, Diospyros Kaki Leaf Extract, Vitis Vinifera (Grape) Fruit Extract, Brassica Campestris (Rapeseed) Sterols, Lavandula Angustifolia (Lavender) Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Borago Officinalis Extract, Centaurea Cyanus Flower Extract, Salvia Sclarea (Clary) Extract, Hyacinthus Orientalis Extract, Camellia Sinensis Leaf Extract, Castanea Crenata (Chestnut) Shell Extract, Zanthoxylum Schinifolium Leaf Extract, Coffea Arabica (Coffee) Seed Extract, Polygonum Cuspidatum Extract, Carthamus Tinctorius (Safflower) Flower Extract, Honey Extract, Eriobotrya Japonica Leaf Extract, Talc, Sucrose, Ceramide NP, Stearic Acid, Polyglutamic Acid, Royal Jelly Extract, Propolis Extract, Oleic Acid, Tocopheryl Acetate, Mineral Salts, sh-Decapeptide-9, Polysorbate 20, Lecithin, Acetyl Hexapeptide-8, Nicotinoyl Tripeptide-1, Nicotinoyl Octapeptide-9, sh-Octapeptide-4, Pentapeptide-37, Decapeptide-12, Caffeoyl Tripeptide-1, sh-Oligopeptide-1, Sh-polypeptide-22, sh-Oligopeptide-2, Sh-polypeptide-5, Sh-polypeptide-60, Sh-polypeptide-2, sh-Polypeptide-4, sh-Polypeptide-11

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings:

    For external use only

    Avoid contact with eyes.

    Discontinue use if signs of irritation or rashes appear.

    Replace the cap after use.

    Keep out of reach of children.

  • DESCRIPTION

    Uses:

    Helps prevent sunburn

    Directions:

    Take a proper amount of the product and spread it evenly over the entire face.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    LAMUSE RETURN 2 BLESSING VISUAL BALM 
    titanium dioxide, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72161-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.36 g  in 15 mL
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate1.05 g  in 15 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.60 g  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    Dimethicone (UNII: 92RU3N3Y1O)  
    Dipropylene Glycol (UNII: E107L85C40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72161-010-021 in 1 CARTON02/01/2018
    1NDC:72161-010-0115 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2018
    Labeler - INVITI INC. (694812156)
    Registrant - INVITI INC. (694812156)
    Establishment
    NameAddressID/FEIBusiness Operations
    DERMAMEAL CO., LTD.694253327manufacture(72161-010)