Laser Sunscreen 100

Manufacturer
CMS LAB Inc. | Kolmar Korea Co., Ltd.
Effective date
2018-01-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:54:17

Label at a glance#

ProductLaser Sunscreen 100
Active ingredientOCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE
Label structure8 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

- Apply the adequate amount onto the entire face at the last stage of your skin care routine. Re-apply frequently and generously to maintain protection. the palm of the hands and pat lightly with the fingertips. - Apply liberally 15 minutes before sun exposure. - Reapply at least every 2 hours. - Use a water-resistant sunscreen if swimming or sweating. - Children under 6 months of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate (7.5%)

Octisalate (5%)

Zinc Oxide (4.8%)

Titanium Dioxide (2.49%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use when skin is red, inflamed, irritated, or painful

When using this product

- do not apply on other parts of the body

- do not use on damaged or broken skin

- avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

- do not apply directly to wound or open cut

Stop use and ask a doctor if

- Rash or irritation on skin develops and lasts

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

- Apply the adequate amount onto the entire face at the last stage of your skin care routine. Re-apply frequently and generously to maintain protection. the palm of the hands and pat lightly with the fingertips.

- Apply liberally 15 minutes before sun exposure.

- Reapply at least every 2 hours.

- Use a water-resistant sunscreen if swimming or sweating.

- Children under 6 months of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, DIPROPYLENE GLYCOL, DICAPRYLYL CARBONATE, PEG-10 DIMETHICONE, LAURYL PEG-8 DIMETHICONE, DIMETHICONE, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, PHENYL TRIMETHICONE, METHYL METHACRYLATE CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PHENOXYETHANOL, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, METHICONE, POLYGLYCERYL-6 POLYRICINOLEATE, CAPRYLYL GLYCOL, FRAGRANCE, GLYCERYL CAPRYLATE, TOCOPHERYL ACETATE, DISODIUM EDTA, HYDROLYZED COLLAGEN, UBIQUINONE, ACETYL HEXAPEPTIDE-8

Laser Sunscreen 100

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

laser sunscreen 100laser sunscreen 100

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52554-1115-22022-01-28C16284748780-1d6a99b39-d048-a426-e053-dadaa90af4c2Laser Sunscreen 100

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52554-1115-1Laser Sunscreen 10035 mL in 1 TUBECREAM354
52554-1115-2Laser Sunscreen 1001 in 1 PACKAGECREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52554-1115LASER SUNSCREEN 100 (OCTISALATE, OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE) CREAM [CMS LAB INC.]4Legacy NDC, 2 package rows20180130_62ede81a-ab15-8e88-e053-2991aa0aa069.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52554-111552554-1115-1, 52554-1115-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

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
63f41ca6-6c48-394c-e053-2991aa0a2b0362ede81a-ab15-8e88-e053-2991aa0aa0692018-01-29WarningsExact identifier
spl id: 63f41ca6-6c48-394c-e053-2991aa0a2b03
spl set id: 62ede81a-ab15-8e88-e053-2991aa0aa069

Reported adverse events (FAERS/openFDA)#

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