FDA.reportPublic FDA data

Lumasol

Manufacturer
Luma Suncare, Inc.
Effective date
2020-03-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:37:35

Label at a glance#

ProductLumasol
Active ingredientHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
Label structure9 sections

Indications and 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

Dosage and administration

* Apply liberally 15 minutes before sun exposure * Use a water resistant sunscreen if swimming or sweating * Reapply * after 80 minutes of swimming or sweating * immediately after towel drying * 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 Broad Spectrum SPF value of 15 or hi...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION


* 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

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION


When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

FLAMMABLE. Do not spray on an open flame or other ignition source. Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

INSTRUCTIONS FOR USE SECTION


* Apply liberally 15 minutes before sun exposure
* Use a water resistant sunscreen if swimming or sweating
* Reapply
* after 80 minutes of swimming or sweating
* immediately after towel drying
* 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
* Limit time in the sun, especially from 10 a.m. to 2 p.m.
* Wear long sleeve shirts, pants, hats and sunglasses

Other Information

OTHER SAFETY INFORMATION

* Do not expose to temperatures exceeding 100 °F/40 °C.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denat., C28-52 Olefin/Undecylenic Acid Copolymer, Isododecane, Dicaprylyl Ether, Cyclopentasiloxane, Diisopropyl Adipate, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Glycerin, Tocopheryl Acetate, Citrus Paradisi (Grapefruit) Peel Oil, Silica Silylate, Menthoxypropanediol

OTC - QUESTIONS SECTION

Questions? Call # (317) 586-2765

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packaging for inner glass

Inner 10 mL vial packageInner 10 mL vial package

First image of outer packaging

Lumasol Outer Packaging Part 1Lumasol Outer Packaging Part 1

Second image of outer packaging

Lumasol Outer Packaging Part 2Lumasol Outer Packaging Part 2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73578-288-102024-03-27C16284748780-1d6a99b39-5457-a426-e053-dadaa90af4c2Lumasol, a sunscreen product.
73578-288-302024-03-27C16284748780-1d6a99b39-5457-a426-e053-dadaa90af4c2Lumasol, a sunscreen product.
73578-288-102022-01-28C16284748780-1d6a99b39-5457-a426-e053-dadaa90af4c2Lumasol, a sunscreen product.
73578-288-302022-01-28C16284748780-1d6a99b39-5457-a426-e053-dadaa90af4c2Lumasol, a sunscreen product.

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73578-28873578-288-10, 73578-288-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
CYCLOMETHICONE 50THT5PCI0RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GRAPEFRUIT OILYR377U58W9IACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ISODODECANEA8289P68Y2IACT
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ALCOHOL3K9958V90MIACT
DICAPRYLYL ETHER77JZM5516ZIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOLKD6TZ2QICHIACT

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
14abe2fb-2185-461a-e063-6294a90ac6f6a2301598-1937-134e-e053-2995a90a0e942024-03-27WarningsExact identifier
spl set id: a2301598-1937-134e-e053-2995a90a0e94

Reported adverse events (FAERS/openFDA)#

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