FDA.reportPublic FDA data

Laser Sunscreen 100

Manufacturer
Humex,Inc. | Kolmar Korea Co., Ltd.
Effective date
2017-07-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:14:35

Label at a glance#

ProductLaser Sunscreen 100
Active ingredientOCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE
Label structure5 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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 SECTION

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 SECTION

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 SECTION

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

Package Label Principal Display PanelPackage Label Principal Display Panel

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
OCTISALATEACTIVE INGREDIENT4X49Y0596W2
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
OCTISALATEACTIVE MOIETY4X49Y0596W2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP2
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z2
Acetyl Hexapeptide-8INACTIVE INGREDIENTL4EL31FWIL2
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA2
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438U2
Dicaprylyl CarbonateINACTIVE INGREDIENT609A3V1SUA2
Dipropylene GlycolINACTIVE INGREDIENTE107L85C402
Disteardimonium HectoriteINACTIVE INGREDIENTX687XDK09L2
Glyceryl CaprylateINACTIVE INGREDIENTTM2TZD4G4A2
Magnesium SulfateINACTIVE INGREDIENTDE08037SAB2
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T2
Phenyl TrimethiconeINACTIVE INGREDIENTDR0K5NOJ4R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76344-800176344-8001-1, 76344-8001-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLENE GLYCOL3XUS85K0RAIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
DIPROPYLENE GLYCOLE107L85C40IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ACETYL HEXAPEPTIDE-8L4EL31FWILIACT
PHENOXYETHANOLHIE492ZZ3TIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 19 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
Dipropylene GlycolDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
3 equally ranked IID candidates
Dipropylene GlycolDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / TRANSDERMAL296 mgExact identifier — unii candidate
3 equally ranked IID candidates
Glyceryl CaprylateGLYCERYL MONOCAPRYLATETM2TZD4G4ACAPSULE / ORAL400 mgExact identifier — unii candidate
2 equally ranked IID candidates
Glyceryl CaprylateGLYCERYL MONOCAPRYLATETM2TZD4G4ATABLET / ORAL1 mgExact identifier — unii candidate
2 equally ranked IID candidates
Magnesium SulfateMAGNESIUM SULFATEDE08037SABTABLET / ORAL2.9 mgExact identifier — unii candidate
6 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
Magnesium SulfateMAGNESIUM SULFATEDE08037SABTABLET, FILM COATED / ORAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
Magnesium SulfateMAGNESIUM SULFATEDE08037SABTABLET, COATED / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
Magnesium SulfateMAGNESIUM SULFATEDE08037SABCAPSULE / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
Magnesium SulfateMAGNESIUM SULFATEDE08037SABTABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
6 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
Magnesium SulfateMAGNESIUM SULFATEDE08037SABSOAP / TOPICAL0.2 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
Dipropylene GlycolDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
3 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d57ec0cf-58b6-5979-e053-2a95a90a1621a99f03a7-4349-4e55-8083-988fdecd99632022-01-13WarningsExact identifier
spl set id: a99f03a7-4349-4e55-8083-988fdecd9963

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.