FDA.reportPublic FDA data

Luminous Intensive Hand Treatment SPF 25

Manufacturer
Erno Laszlo, Inc. | Mana Products
Effective date
2013-04-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:35:18

Label at a glance#

ProductLuminous Intensive Hand Treatment SPF 25
Active ingredientAvobenzone, Octinoxate, Octisalate
Label structure11 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 reapply: after 40 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 a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, ...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%, Octinoxate 7.5%, Octisalate 5%

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.

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

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure

  • reapply: after 40 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 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Butyrospermum Parkii (Shea Butter), Octyldodecyl Neopentanoate, Cetyl Alcohol, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Cyclomethicone, Steareth-20, Ceteth-20, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Taraktogenos Kurzii Seed Oil, Glycerin, Centella Asiatica Extract, Echinacea Purpurea Extract, Saxifraga Sarmentosa Extract, Vitis Vinifera (Grape) Fruit Extract, Morus Nigra Root Extract, Scutellaria Baicalensis Root Extract, Algae Extract, Fragrance, Carbomer, Phenoxyethanol, Isopropylparaben, Isobutylparaben, Butylparaben, Sodium Hydroxide.

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free at 866-452-7956.

SPL UNCLASSIFIED SECTION

DISTRIBUTED IN U.S.A. BY ERNO LASZLO NEW YORK, NY 10001

PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ERNO
LASZLO

NEW YORK

LUMINOUS

INTENSIVE HAND TREATMENT
SPF 25

100mL e 3.3 fl.oz.

Principal Display Panel - 100 mL Tube Carton
Principal Display Panel - 100 mL Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57913-2525-92020-01-31C16284748780-19d75b9d0-681a-f424-e053-dadaa90a57ceLuminous Intensive Hand Treatment SPF 25

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57913-2525-9Luminous Intensive Hand Treatment SPF 25100 mL in 1 TUBELOTION1001
57913-2525-9Luminous Intensive Hand Treatment SPF 251 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57913-2525LUMINOUS INTENSIVE HAND TREATMENT SPF 25 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1Legacy NDC, 2 package rows20130502_6285f1f0-fd0c-4094-9f64-e9bf1bce8b85.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX1
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OctisalateACTIVE INGREDIENT4X49Y0596W1
AvobenzoneACTIVE MOIETYG63QQF2NOX1
OctinoxateACTIVE MOIETY4Y5P7MUD511
OctisalateACTIVE MOIETY4X49Y0596W1
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC11
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV81
CENTELLA ASIATICAINACTIVE INGREDIENT7M867G6T1U1
CETETH-20INACTIVE INGREDIENTI835H2IHHX1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994Z1
ECHINACEA PURPUREAINACTIVE INGREDIENTQI7G114Y981
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
HYDNOCARPUS KURZII SEED OILINACTIVE INGREDIENTN757YEZ18Q1
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58G1
ISOPROPYLPARABENINACTIVE INGREDIENTA6EOX47QK01
JOJOBA OILINACTIVE INGREDIENT724GKU717M1
MORUS NIGRA ROOTINACTIVE INGREDIENT033456LFG11
OCTYLDODECYL NEOPENTANOATEINACTIVE INGREDIENTX8725R883T1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SAXIFRAGA STOLONIFERA LEAFINACTIVE INGREDIENTO3TMV4903H1
SCUTELLARIA BAICALENSIS ROOTINACTIVE INGREDIENT7J95K7ID2S1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
STEARETH-20INACTIVE INGREDIENTL0Q8IK9E081
WATERINACTIVE INGREDIENT059QF0KO0R1
WINE GRAPEINACTIVE INGREDIENT3GOV20705G1

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57913-252557913-2525-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
Octinoxate4Y5P7MUD51ACTIB
Octisalate4X49Y0596WACTIB
WATER059QF0KO0RIACT
SHEA BUTTERK49155WL9YIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
CETYL ALCOHOL936JST6JCNIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
CYCLOMETHICONENMQ347994ZIACT
STEARETH-20L0Q8IK9E08IACT
CETETH-20I835H2IHHXIACT
AVOCADO OIL6VNO72PFC1IACT
JOJOBA OIL724GKU717MIACT
HYDNOCARPUS KURZII SEED OILN757YEZ18QIACT
GLYCERINPDC6A3C0OXIACT
CENTELLA ASIATICA7M867G6T1UIACT
ECHINACEA PURPUREAQI7G114Y98IACT
SAXIFRAGA STOLONIFERA LEAFO3TMV4903HIACT
WINE GRAPE3GOV20705GIACT
MORUS NIGRA ROOT033456LFG1IACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ISOPROPYLPARABENA6EOX47QK0IACT
ISOBUTYLPARABEN0QQJ25X58GIACT
BUTYLPARABEN3QPI1U3FV8IACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML · Source PDF

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 7 · 406 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS78.36 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, COATED / ORALNAExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISYRUP / ORAL71 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SOLUTION / RECTAL0.01 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, COATED / ORAL0.25 mgExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRADISCALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8CREAM / TOPICAL0.4 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPOWDER / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRATUMORADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, EXTENDED RELEASE / ORAL529 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / VAGINAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / ORAL2 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, COATED / ORAL0.08 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRACAUDALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LIQUID / RESPIRATORY (INHALATION)10 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii candidate
15 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / URETERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8TABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / TOPICAL82 mgExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IENEMA / RECTAL0.44 %v/vExact identifier — unii candidate
174 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8OINTMENT / TOPICAL0.18 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVENOUS456 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / DENTALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / PERINEURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CYCLOMETHICONECYCLOMETHICONENMQ347994ZSOLUTION / TOPICAL11.57 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCAPSULE, DELAYED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
CETETH-20CETETH-20I835H2IHHXSOLUTION / TOPICAL2 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / VAGINAL100 mgExact identifier — unii candidate
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, EXTENDED RELEASE / ORAL13 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR5.4 mgExact identifier — unii candidate
174 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
fe301d66-7a2a-40ff-9f68-be31eefa5c3c6285f1f0-fd0c-4094-9f64-e9bf1bce8b852013-04-09WarningsExact identifier
spl id: fe301d66-7a2a-40ff-9f68-be31eefa5c3c
spl set id: 6285f1f0-fd0c-4094-9f64-e9bf1bce8b85

Reported adverse events (FAERS/openFDA)#

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