SUPERSMOOTH ACNE CLEAR 5 MIN MASK- salicylic acid cream

SUPERSMOOTH ACNE CLEAR 5 MIN MASK by

Drug Labeling and Warnings

SUPERSMOOTH ACNE CLEAR 5 MIN MASK by is a Otc medication manufactured, distributed, or labeled by GLAMGLOW LLC, Estee Lauder Companies Inc., The Estee Lauder Inc, PADC 1, Northtec LLC, PALC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid 1.0%

Purpose

Acne Treatment

Use

• For the treatment of acne
• Helps clear acne blemishes
• Helps prevent development of new acne blemishes

Warnings

For external use only

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If this occurs, use only one topical acne medication at a time.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• As a cleansing scrub, massage gently over wet skin avoiding eye area; rinse with water
• Because excessive drying of the skin may occur, start with one use daily, then gradually increase to twice daily, or as directed by a doctor
• If bothersome dryness or peeling occurs, reduce use to once a day or every other day
• As a 5 minute mask (one to two times per week), apply a thin layer over the face or affected areas, avoiding eye area; rinse with water

Inactive Ingredients

WATER\AQUA\EAU KAOLIN GLYCERIN BUTYLENE GLYCOL MAGNESIUM ALUMINUM SILICATE GLYCERYL STEARATE PEG-100 STEARATE SILICA SODIUM LAUROYL SARCOSINATE TOCOPHERYL ACETATE CHARCOAL POWDER ACETYL GLUCOSAMINE SUCROSE GENTIANA LUTEA (GENTIAN) ROOT EXTRACT LAMINARIA SACCHARINA EXTRACT XANTHAN GUM SODIUM HYDROXIDE CAPRYLYL GLYCOL 1,2-HEXANEDIOL ALLYL METHACRYLATES CROSSPOLYMER FRAGRANCE (PARFUM) LINALOOL DISODIUM EDTA TETRASODIUM EDTA PHENOXYETHANOL TITANIUM DIOXIDE (CI 77891) IRON OXIDES (CI 77499) <ILN49835>

PRINCIPAL DISPLAY PANEL - 125 ml Tube Label

SUPERSMOOTH™
ACNE CLEARING 5-MINUTE MASK TO SCRUB

HOLLYWOOD, CALIFORNIA
GLAMGLOW ®

★ CLEAR ★ SMOOTH ★ REFINE ★

4.2 FL. OZ. LIQ/125 ml ℮

INGREDIENTS AND APPEARANCE

SUPERSMOOTH ACNE CLEAR 5 MIN MASK 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82753-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
KAOLIN (UNII: 24H4NWX5CO)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
SUCROSE (UNII: C151H8M554)
GENTIANA LUTEA ROOT (UNII: S72O3284MS)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALLYL METHACRYLATE (UNII: G2IG50653Z)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82753-001-01	125 mL in 1 TUBE; Type 0: Not a Combination Product	05/25/2022
2	NDC: 82753-001-02	15 mL in 1 TUBE; Type 0: Not a Combination Product	05/25/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	05/25/2022

Labeler - GLAMGLOW LLC (079784541)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
The Estee Lauder Inc		802599436	manufacture(82753-001) , pack(82753-001) , label(82753-001)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	pack(82753-001) , label(82753-001)

Establishment
Name	Address	ID/FEI	Business Operations
Northtec LLC		943871157	pack(82753-001) , label(82753-001)

Establishment
Name	Address	ID/FEI	Business Operations
PALC		078364654	pack(82753-001) , label(82753-001)