Nuviléo™ Skin Perfecting Acne Cream

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 Skin Perfecting Acne

Active ingredientSalicylic Acid

Label structure8 sections

Indications and uses

for treatment of acne

Dosage and administration

Apply thin layer of cream on affected skin surface.

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.

OTC - WHEN USING SECTION

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

Apply thin layer of cream on affected skin surface.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf, Aloe barbadensis mill, C13-14 Isoparaffin, Caprylyl Glycol, Citrus Grandis (Grapefruit) Peel Oil, Cyclomethicone, Disodium EDTA, Emulsifying Wax, Ethylhexyl Stearate, Hydrastis canadensis L., Laureth-7, Olea Europaea (Olive) Fruit Oil, Panax quinquefolius L., Passiflora Incarnata, Phenoxyethanol, Polyacrylamide, Purified Water, Sorbitol, Tocopheryl Acetate, Triethanolamine

PRINCIPAL DISPLAY PANEL - 60 ml Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nuviléo™

Skin Perfecting
Acne Cream

Residue free acne cream for
Clear Skin Everyday

Reduces redness
Clears breakouts
Hydrates, soothes & repairs

Salicylic Acid Acne Treatment

2 FL. OZ. / 60 ml.

Principal Display Panel - 60 ml Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1658308	Nuvileo 2 % Topical Cream	PSN	1
317152	salicylic acid 2 % Topical Cream	PSN	1
1658308	salicylic acid 20 MG/ML Topical Cream [Nuvileo]	SBD	1
317152	salicylic acid 20 MG/ML Topical Cream	SCD	1
1658308	Nuvileo 2 % Topical Cream	SY	1
317152	salicylic acid 2 % Topical Cream	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58133-500-02	2020-01-31	C162847	48780-1	9d75b9d0-f6fa-f424-e053-dadaa90a57ce	Nuviléo™ Skin Perfecting Acne Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58133-500-02	Nuvileo Skin Perfecting Acne	60 mL in 1 TUBE	CREAM	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58133-500	NUVILEO SKIN PERFECTING ACNE (SALICYLIC ACID) CREAM [COSMETIC SPECIALTY LABS, INC.]	1	Legacy NDC, 1 package rows	20150721_731c60f5-8b27-41d6-baaf-1f4723e92aa9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Salicylic Acid	ACTIVE INGREDIENT	O414PZ4LPZ	1
Salicylic Acid	ACTIVE MOIETY	O414PZ4LPZ	1
.Alpha.-Tocopherol Acetate	INACTIVE INGREDIENT	9E8X80D2L0	1
Allantoin	INACTIVE INGREDIENT	344S277G0Z	1
Aloe Vera Leaf	INACTIVE INGREDIENT	ZY81Z83H0X	1
Aloe Vera Whole	INACTIVE INGREDIENT	KIZ4X2EHYX	1
C13-14 Isoparaffin	INACTIVE INGREDIENT	E4F12ROE70	1
Caprylyl Glycol	INACTIVE INGREDIENT	00YIU5438U	1
Citrus Maxima Fruit Rind Oil	INACTIVE INGREDIENT	8U3877WD44	1
Cyclomethicone	INACTIVE INGREDIENT	NMQ347994Z	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	1
Ethylhexyl Stearate	INACTIVE INGREDIENT	EG3PA2K3K5	1
Hydrastis Canadensis Whole	INACTIVE INGREDIENT	R763EBH88T	1
Laureth-7	INACTIVE INGREDIENT	Z95S6G8201	1
Olive Oil	INACTIVE INGREDIENT	6UYK2W1W1E	1
Panax Quinquefolius Whole	INACTIVE INGREDIENT	0P067WOA1X	1
Passiflora Incarnata Flowering Top	INACTIVE INGREDIENT	CLF5YFS11O	1
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	1
Trolamine	INACTIVE INGREDIENT	9O3K93S3TK	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

Nuvileo Skin Perfecting Acne
Salicylic Acid
Allantoin
Aloe Vera Leaf
Aloe Vera Whole
C13-14 Isoparaffin
Caprylyl Glycol
Citrus Maxima Fruit Rind Oil
Cyclomethicone
Edetate Disodium
Ethylhexyl Stearate
Hydrastis Canadensis Whole
Laureth-7
Olive Oil
Panax Quinquefolius Whole
Passiflora Incarnata Flowering Top
Phenoxyethanol
Water
Sorbitol
.Alpha.-Tocopherol Acetate
Trolamine

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58133-500	58133-500-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Salicylic Acid	O414PZ4LPZ	ACTIB
Allantoin	344S277G0Z	IACT
Aloe Vera Leaf	ZY81Z83H0X	IACT
Aloe Vera Whole	KIZ4X2EHYX	IACT
C13-14 Isoparaffin	E4F12ROE70	IACT
Caprylyl Glycol	00YIU5438U	IACT
Citrus Maxima Fruit Rind Oil	8U3877WD44	IACT
Cyclomethicone	NMQ347994Z	IACT
Edetate Disodium	7FLD91C86K	IACT
Ethylhexyl Stearate	EG3PA2K3K5	IACT
Hydrastis Canadensis Whole	R763EBH88T	IACT
Laureth-7	Z95S6G8201	IACT
Olive Oil	6UYK2W1W1E	IACT
Panax Quinquefolius Whole	0P067WOA1X	IACT
Passiflora Incarnata Flowering Top	CLF5YFS11O	IACT
Phenoxyethanol	HIE492ZZ3T	IACT
Water	059QF0KO0R	IACT
Sorbitol	506T60A25R	IACT
.Alpha.-Tocopherol Acetate	9E8X80D2L0	IACT
Trolamine	9O3K93S3TK	IACT

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 3 · 163 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Olive Oil	OLIVE OIL	6UYK2W1W1E	LOTION / TOPICAL		32468 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	GEL / OPHTHALMIC		396 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SYSTEM / IONTOPHORESIS	0.1 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
.Alpha.-Tocopherol Acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
Cyclomethicone	CYCLOMETHICONE	NMQ347994Z	CREAM / TOPICAL	13 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION, SOLUTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	CREAM / TOPICAL	1 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / NASAL	100 mg/100ml		Exact identifier — unii candidate 77 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Allantoin	ALLANTOIN	344S277G0Z	GEL / TOPICAL		8 mg	Exact identifier — unii candidate
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION / INTRA-ARTICULAR	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SPRAY / NASAL		49 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET, COATED / ORAL	12.96 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	GUM, CHEWING / ORAL		6168 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, EFFERVESCENT / ORAL		32 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	SPRAY / NASAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / SUBCUTANEOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	DROPS / NASAL	0.1 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, EMULSION / INTRAVENOUS		59 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION / OPHTHALMIC		6 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	SHAMPOO / TOPICAL	3.7 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET / SUBLINGUAL	50.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION / INTRASYNOVIAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	GEL / TRANSDERMAL		6 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	DROPS / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAVENOUS		7 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / NASAL	2 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	LOTION / TOPICAL	10.7 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	CREAM / VAGINAL		56 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	CREAM, AUGMENTED / TOPICAL		20 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	INJECTION / INTRAVENOUS		1276 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 77 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
230eff3b-ad49-4729-8b6c-2bd56e15b61b			731c60f5-8b27-41d6-baaf-1f4723e92aa9	2015-07-15	Warnings	Exact identifier spl id: 230eff3b-ad49-4729-8b6c-2bd56e15b61b spl set id: 731c60f5-8b27-41d6-baaf-1f4723e92aa9

Reported adverse events (FAERS/openFDA)#

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