LAPCOS LASTING WATERPROOF SUN- octinoxate, octisalate, zinc oxide, titanium dioxide cream
LAP CO.,LTD

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.

----------

ACTIVE INGREDIENT

Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Ethylhexyl Salicylate 5.0%, Zinc Oxide 4.8%, Titanium Dioxide 2.9%

INACTIVE INGREDIENT

Inactive ingredients: Water,Cyclopentasiloxane, PEG-10 Dimethicone, Dimethicone,Dipropylene Glycol,Portulaca Oleracea Extract,Magnesium Sulfate,Disteardimonium Hectorite,C30-45 Alkyl Cetearyl Dimethicone Crosspolymer,Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer,Isoamyl p-Methoxycinnamate,Aluminum Hydroxide,Stearic Acid,Caffeine,Butylene Glycol,Triethoxycaprylylsilane,Disodium EDTA,Phenoxyethanol,Potassium Sorbate,Fragrance(Parfum),Iron Oxides (CI 77491),Iron Oxides (CI 77492)

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 - Higher SPF gives more sun protection

Directions: - Apply generously and as needed. - Children under 6 months of age : Ask a doctor. - Reapply as needed or after towel drying, swimming or sweating.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

LAPCOS LASTING WATERPROOF SUN
octinoxate, octisalate, zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71379-020
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	3.50 g in 50 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	2.50 g in 50 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.40 g in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.45 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Dimethicone (UNII: 92RU3N3Y1O)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71379-020-02	1 in 1 CARTON	04/01/2017
1	NDC:71379-020-01	50 mL in 1 CONTAINER; Type 0: Not a Combination Product

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

Labeler - LAP CO.,LTD (689041115)

Registrant - LAP CO.,LTD (689041115)

Name	Address	ID/FEI	Business Operations
Establishment
LAP CO.,LTD		689041115	relabel(71379-020)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmax, Inc		689049693	manufacture(71379-020)