LAPCOS DOUBLET COVER CUSHION 01 ROSY IVORY- titanium dioxide, octinoxate, octisalate powder

LAPCOS Doublet Cover Cushion 01 Rosy Ivory by

Drug Labeling and Warnings

LAPCOS Doublet Cover Cushion 01 Rosy Ivory by is a Otc medication manufactured, distributed, or labeled by LAP CO.,LTD, Cosmax, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Titanium Dioxide 13.7%, Ethylhexyl Methoxycinnamate 6.7%, Ethylhexyl Salicylate 4.0%

INACTIVE INGREDIENT

Inactive ingredients: Water, Cyclopentasiloxane, Butylene Glycol, PEG-8 Dimethicone, Glycerin, Niacinamide, Butylene Glycol Dicaprylate/Dicaprate, Caprylyl Methicone, Trimethylsiloxysilicate, Pentylene Glycol, Iron Oxides (CI 77492), Rosa Canina Fruit Oil, Tremella Fuciformis (Mushroom) Extract, Hydrolyzed Pearl, Honey Extract, Actinidia Polygama Fruit Extract, Dimethicone, Magnesium Sulfate, Synthetic Fluorphlogopite, Diphenyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer, Stearic Acid, Alumina, Dimethicone Crosspolymer, Aluminum Hydroxide, Triethoxycaprylylsilane, Disteardimonium Hectorite, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Adenosine, Hydrogenated Castor Oil Isostearate, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Polyglutamic Acid, Ethyl Hexanediol, Ceramide 3, Polysorbate 20, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Carbomer, Disodium EDTA, Phenoxyethanol, Fragrance(Parfum), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

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. 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.

Directions: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. 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 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LAPCOS DOUBLET COVER CUSHION 01 ROSY IVORY 
titanium dioxide, octinoxate, octisalate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71379-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.64 g  in 12 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	0.80 g  in 12 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	0.48 g  in 12 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71379-030-02	1 in 1 CARTON	04/01/2017
1	NDC: 71379-030-01	12 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2017

Labeler - LAP CO.,LTD (689041115)

Registrant - LAP CO.,LTD (689041115)

Establishment
Name	Address	ID/FEI	Business Operations
LAP CO.,LTD		689041115	relabel(71379-030)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc		689049693	manufacture(71379-030)