LASER SUNSCREEN 100- octinoxate, octisalate, zinc oxide, titanium dioxide cream

Laser Sunscreen 100 by

Drug Labeling and Warnings

Laser Sunscreen 100 by is a Otc medication manufactured, distributed, or labeled by Humex,Inc., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active ingredients                                                                                             Purpose

Ethylhexyl Methoxycinnamate 7.50% --------------------------------------------- Sunscreen 

Ethylhexyl Salicylate 5.00%---------------------------------------------------------- Sunscreen 

Zinc Oxide 4.80% ---------------------------------------------------------------------- Sunscreen 

Titanium Dioxide 2.49% -------------------------------------------------------------- Sunscreen 

WARNINGS AND PRECAUTIONS

Warnings
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs
Keep out of reach of children. If product is swallowed, get medical
help or contact a Poison Control Center right away.

INSTRUCTIONS FOR USE

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
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
use a water-resistant sunscreen if swimming or sweating

INACTIVE INGREDIENT

Inactive Ingredient

■ Water ■ Cyclopentasiloxane ■ Butylene Glycol ■ Dicaprylyl Carbonate ■ Dipropylene Glycol ■ Lauryl PEG-8 Dimethicon ■ PEG-10 Dimethicon ■ Dimethicon ■ Disteardimonium Hectorite ■ Tocopheryl Acetate ■ Magnesium Sulfate ■ Dimethicone/Vinyl Dimethicone Crosspolymer ■ Methyl Methacrylate Crosspolymer ■ Phenyl Trimethicone ■ Aluminium Hydroxide ■ Aluminium Stearate ■ Methicone ■ Polyglyceryl-6 Polyricinoleate ■ Glyceryl Caprylate ■ Caprylyl Glycol ■ Disodium EDTA■ Ubiquinone ■ Hydrolyzed Collagen ■ Acetyl Hexapeptide-8 ■ Fragrance ■ Phenoxyethanol

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LASER SUNSCREEN 100 
octinoxate, octisalate, zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76344-8001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.8 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.49 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Product Characteristics
Color	white (milky white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76344-8001-2	1 in 1 BOX	07/26/2017
1	NDC: 76344-8001-1	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2014

Labeler - Humex,Inc. (017945311)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(76344-8001)