FDA.reportPublic FDA data

Nuvileo Acne Face Wash

Manufacturer
Cosmetic Specialty Labs, Inc. | Cosmetic Specialty Labs
Effective date
2015-07-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:43:07

Label at a glance#

ProductNuvileo Acne Face Wash
Active ingredientSalicylic Acid
Label structure8 sections

Indications and uses

for treatment of acne

Dosage and administration

Use twice a day. Wet face, apply to hands, add water and work into a lather. Massage into your face, rinse.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

for treatment of acne

Warnings

WARNINGS SECTION

for external use only

OTC - ASK DOCTOR SECTION

Ask a doctor if you are using other topical acne medications at the same time or immediately following use of this product. If increased dryness or irritation occurs, only one medication should be used, unless directed by a doctor.

Avoid contact with eyes. If contact occurs, flush thoroughly with water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Use twice a day. Wet face, apply to hands, add water and work into a lather. Massage into your face, rinse.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Mill, Caprylyl Glycol, Cocamidopropyl Betaine, Coco-Glucoside, Fragrance, Glyceryl Oleate, Hydrastis canadensis L., Lauramide D A, Lauryl Gucoside, Organic Greenhouse Grown Aloe Barbadensis Leaf, Panax quinquefolis L., Phenoxyethanol, Purified Water, Sodium Citrate, Sodium Lauryl Glucose Carboxylate.

PRINCIPAL DISPLAY PANEL - 180 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nuviléo™
Acne Face Wash

Oil-free AM / PM cleanser for
Clear Skin Everyday

Non-Drying Formula

  • Reduces redness
  • Clears breakouts
  • Gently exfoliates skin
  • Removes excess oil, dirt & makeup

Salicylic Acid Acne Treatment

6 FL. OZ. / 180 ml.

Principal Display Panel - 180 ml Bottle Label
Principal Display Panel - 180 ml Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1658311Nuvileo 2 % Medicated Liquid SoapPSN1
562600salicylic acid 2 % Medicated Liquid SoapPSN1
1658311salicylic acid 20 MG/ML Medicated Liquid Soap [Nuvileo]SBD1
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD1
1658311Nuvileo 2 % Medicated Liquid SoapSY1
562600salicylic acid 2 % Facial Cleanser TonerSY1
562600salicylic acid 2 % Facial ScrubSY1
562600salicylic acid 2 % Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-501-032020-01-31C16284748780-19d75b9d0-9f4c-f424-e053-dadaa90a57ceNuviléo™ Acne Face Wash
58133-501-062020-01-31C16284748780-19d75b9d0-9f4c-f424-e053-dadaa90a57ceNuviléo™ Acne Face Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-501-03Nuvileo Acne Face Wash90 mL in 1 BOTTLESOLUTION, GEL FORMING / DROPS901
58133-501-06Nuvileo Acne Face Wash180 mL in 1 BOTTLESOLUTION, GEL FORMING / DROPS1801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-501NUVILEO ACNE FACE WASH (SALICYLIC ACID) SOLUTION, GEL FORMING / DROPS [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 2 package rows20150721_dd31ffbd-88ba-4af3-9c97-a3cf4d66fbfc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZ1
Salicylic AcidACTIVE MOIETYO414PZ4LPZ1
Aloe Vera WholeINACTIVE INGREDIENTKIZ4X2EHYX1
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438U1
Cocamidopropyl BetaineINACTIVE INGREDIENT5OCF3O11KX1
Coco GlucosideINACTIVE INGREDIENTICS790225B1
Glyceryl OleateINACTIVE INGREDIENT4PC054V79P1
Hydrastis Canadensis WholeINACTIVE INGREDIENTR763EBH88T1
Lauryl GlucosideINACTIVE INGREDIENT76LN7P7UCU1
Panax Quinquefolius WholeINACTIVE INGREDIENT0P067WOA1X1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULR1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-50158133-501-06, 58133-501-03

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
Salicylic AcidO414PZ4LPZACTIB
Aloe Vera WholeKIZ4X2EHYXIACT
Caprylyl Glycol00YIU5438UIACT
Cocamidopropyl Betaine5OCF3O11KXIACT
Coco GlucosideICS790225BIACT
Glyceryl Oleate4PC054V79PIACT
Hydrastis Canadensis WholeR763EBH88TIACT
Lauryl Glucoside76LN7P7UCUIACT
Panax Quinquefolius Whole0P067WOA1XIACT
PhenoxyethanolHIE492ZZ3TIACT
Water059QF0KO0RIACT
Sodium Citrate1Q73Q2JULRIACT

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 · 13 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Glyceryl OleateGLYCERYL OLEATE4PC054V79PPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
Glyceryl OleateGLYCERYL OLEATE4PC054V79PCAPSULE / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
Glyceryl OleateGLYCERYL OLEATE4PC054V79PCREAM, AUGMENTED / TOPICAL3.5 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
Glyceryl OleateGLYCERYL OLEATE4PC054V79PFILM, EXTENDED RELEASE / TRANSDERMAL18.8 mgExact identifier — unii candidate
7 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
Glyceryl OleateGLYCERYL OLEATE4PC054V79PSPRAY / TOPICAL0.95 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
Glyceryl OleateGLYCERYL OLEATE4PC054V79PTABLET / ORAL3 mgExact identifier — unii candidate
7 equally ranked IID candidates
Glyceryl OleateGLYCERYL OLEATE4PC054V79PGEL / TOPICAL1 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 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
b7abc303-2b67-4eb3-8949-22dca4dad33add31ffbd-88ba-4af3-9c97-a3cf4d66fbfc2015-07-15WarningsExact identifier
spl id: b7abc303-2b67-4eb3-8949-22dca4dad33a
spl set id: dd31ffbd-88ba-4af3-9c97-a3cf4d66fbfc

Reported adverse events (FAERS/openFDA)#

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