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

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

■ 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

Package Label Principal Display Panel

LASER SUNSCREEN 100 
octinoxate, octisalate, zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76344-8001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.8 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.49 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (milky white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76344-8001-21 in 1 BOX07/26/2017
1NDC:76344-8001-150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/201401/01/2018
Labeler - Humex,Inc. (017945311)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(76344-8001)

Revised: 1/2022
 
Humex,Inc.