LAMUSE RETURN 2 BLESSING VISUAL BALM- titanium dioxide, octinoxate, octisalate cream 
INVITI INC.

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.

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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

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)

Revised: 3/2018
Document Id: 884614cc-409a-48e3-ba87-f47da4c17a8b
Set id: 0f23062a-ae42-4a5d-8c7d-a2b530d9181d
Version: 2
Effective Time: 20180315
 
INVITI INC.