FDA.reportPublic FDA data

Luminous Intensive Decollote Treatment SPF 20

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 22:35:16

Label at a glance#

ProductLuminous Intensive Decollote Treatment SPF 20
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

Cyclomethicone, Dimethicone Crosspolymer, Polysilicone-11, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Salicylic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Retinyl Palmitate, Fragrance, Isopropylparaben, Isobutylparaben, Butylparaben.

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 - 50 mL Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ERNO
LASZLO

NEW YORK

LUMINOUS

INTENSIVE DÉCOLLETÉ TREATMENT SPF 20

50mL e 1.7 fl.oz.

Principal Display Panel - 50 mL Jar Carton
Principal Display Panel - 50 mL Jar Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57913-2815-02020-01-31C16284748780-19d75b9d1-17e5-f424-e053-dadaa90a57ceLuminous Intensive Decollote Treatment SPF 20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57913-2815-0Luminous Intensive Decollote Treatment SPF 201 in 1 CARTONLOTION11
57913-2815-0Luminous Intensive Decollote Treatment SPF 2050 mL in 1 JARLOTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57913-2815LUMINOUS INTENSIVE DECOLLOTE TREATMENT SPF 20 (AVOBENZONE, OCTINOXATE, AND OCTISALATE) LOTION [ERNO LASZLO, INC.]1Legacy NDC, 2 package rows20130426_2712090e-923e-4bd5-a1fa-51b41f770f38.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX1
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OctisalateACTIVE INGREDIENT4X49Y0596W1
AvobenzoneACTIVE MOIETYG63QQF2NOX1
OctinoxateACTIVE MOIETY4Y5P7MUD511
OctisalateACTIVE MOIETY4X49Y0596W1
.Alpha.-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L01
butylparabenINACTIVE INGREDIENT3QPI1U3FV81
CyclomethiconeINACTIVE INGREDIENTNMQ347994Z1
Hexyl LaurateINACTIVE INGREDIENT4CG9F9W01Q1
IsobutylparabenINACTIVE INGREDIENT0QQJ25X58G1
IsopropylparabenINACTIVE INGREDIENTA6EOX47QK01
Polyglyceryl-4 IsostearateINACTIVE INGREDIENT820DPX33S71
Salicylic AcidINACTIVE INGREDIENTO414PZ4LPZ1
Tetrahexyldecyl AscorbateINACTIVE INGREDIENT9LBV3F07AZ1
Vitamin A PalmitateINACTIVE INGREDIENT1D1K0N0VVC1

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
57913-281557913-2815-0

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
AvobenzoneG63QQF2NOXACTIB
Octinoxate4Y5P7MUD51ACTIB
Octisalate4X49Y0596WACTIB
CyclomethiconeNMQ347994ZIACT
Polyglyceryl-4 Isostearate820DPX33S7IACT
Hexyl Laurate4CG9F9W01QIACT
Salicylic AcidO414PZ4LPZIACT
Tetrahexyldecyl Ascorbate9LBV3F07AZIACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT
Vitamin A Palmitate1D1K0N0VVCIACT
IsopropylparabenA6EOX47QK0IACT
Isobutylparaben0QQJ25X58GIACT
butylparaben3QPI1U3FV8IACT

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 · 23 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
butylparabenBUTYLPARABEN3QPI1U3FV8CAPSULE, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
CyclomethiconeCYCLOMETHICONENMQ347994ZCREAM, AUGMENTED / TOPICAL7.6 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
CyclomethiconeCYCLOMETHICONENMQ347994ZLOTION / TOPICAL3510 mgExact identifier — unii candidate
5 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8TABLET, COATED / ORAL0.08 mgExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8SOLUTION / ORAL6 mgExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8SOLUTION / OPHTHALMIC0.02 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8DROPS / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8CREAM / TOPICAL0.4 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8LOTION / TOPICAL4 mgExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8OINTMENT / TOPICAL0.18 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8LIQUID / TOPICAL0.02 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
CyclomethiconeCYCLOMETHICONENMQ347994ZCREAM / TOPICAL13 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
CyclomethiconeCYCLOMETHICONENMQ347994ZSOLUTION / TOPICAL11.57 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii candidate
15 equally ranked IID candidates
CyclomethiconeCYCLOMETHICONENMQ347994ZAEROSOL, FOAM / TOPICAL5.26 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8SYRUP / ORAL28.4 mg/1mlExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8SOLUTION / RECTAL0.01 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8CAPSULE / ORALNAExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8TABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
15 equally ranked IID candidates
butylparabenBUTYLPARABEN3QPI1U3FV8TABLET / ORALNAExact identifier — unii candidate
15 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
949958b9-b17b-48ee-abf3-74cfd85103c92712090e-923e-4bd5-a1fa-51b41f770f382013-04-09WarningsExact identifier
spl id: 949958b9-b17b-48ee-abf3-74cfd85103c9
spl set id: 2712090e-923e-4bd5-a1fa-51b41f770f38

Reported adverse events (FAERS/openFDA)#

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