NUVILEO SKIN PERFECTING ACNE- salicylic acid cream

Nuvileo Skin Perfecting Acne by

Drug Labeling and Warnings

Nuvileo Skin Perfecting Acne by is a Otc medication manufactured, distributed, or labeled by Cosmetic Specialty Labs, Inc., Cosmetic Specialty Labs . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Salicylic Acid 2%

Purpose

Acne Treatment

Uses

for treatment of acne

Warnings

for external use only

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.

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

Directions

Apply thin layer of cream on affected skin surface.

Inactive ingredients

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

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.

INGREDIENTS AND APPEARANCE

NUVILEO SKIN PERFECTING ACNE 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	20 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-500-02	60 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	06/30/2015

Labeler - Cosmetic Specialty Labs, Inc. (032973000)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Specialty Labs		032973000	MANUFACTURE(58133-500)