NDC Code(s) : 49527-997-01, 49527-997-02, 49527-997-03
Packager : CLINIQUE LABORATORIES LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ACNE solutions BENZOYL PEROXIDE LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-997
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE(UNII: W9WZN9A0GM)
(BENZOYL PEROXIDE - UNII:W9WZN9A0GM) 		BENZOYL PEROXIDE25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DIMETHICONE(UNII: 92RU3N3Y1O)
ASTROCARYUM MURUMURU SEED BUTTER(UNII: 12V64UPU6R)
GLYCERIN(UNII: PDC6A3C0OX)
CHOLESTEROL(UNII: 97C5T2UQ7J)
XANTHAN GUM(UNII: TTV12P4NEE)
SUCROSE(UNII: C151H8M554)
BARLEY(UNII: 5PWM7YLI7R)
GLUCOSAMINE(UNII: N08U5BOQ1K)
GENTIANA LUTEA ROOT(UNII: S72O3284MS)
SACCHAROMYCES LYSATE(UNII: R85W246Z1C)
MYRISTYL ALCOHOL(UNII: V42034O9PU)
LINOLEIC ACID(UNII: 9KJL21T0QJ)
CUCUMBER(UNII: YY7C30VXJT)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
EDETATE DISODIUM(UNII: 7FLD91C86K)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
LIMOSILACTOBACILLUS REUTERI(UNII: 9913I24QEE)
FU LING(UNII: XH37TWY5O4)
POLY(METHYL METHACRYLATE; 450000 MW)(UNII: Z47NNT4J11)
ACRYLAMIDOPROPYLTRIMONIUM CHLORIDE/ACRYLAMIDE COPOLYMER (400 MPA.S)(UNII: 2RX4MI2LCX)
ZEOLITE A(UNII: Y3NG9WF08W)
AGAR, UNSPECIFIED(UNII: 89T13OHQ2B)
10-HYDROXYDECANOIC ACID(UNII: NP03XO416B)
CAFFEINE(UNII: 3G6A5W338E)
.ALPHA.-BISABOLOL, (+)-(UNII: 105S6I733Z)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL DICAPRATE(UNII: U783H9JHWY)
CAPRYLOYL GLYCINE(UNII: 8TY5YO42NJ)
SUNFLOWER SEED(UNII: R9N3379M4Z)
QUATERNIUM-22(UNII: MXO138JCBP)
ISOHEXADECANE(UNII: 918X1OUF1E)
CHLOROXYLENOL(UNII: 0F32U78V2Q)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49527-997-011 in 1 CARTON 24/11/2020
150 mL in 1 TUBE Type 0: Not a Combination Product
2NDC:49527-997-021 in 1 CARTON 24/11/2020
230 mL in 1 TUBE Type 0: Not a Combination Product
3NDC:49527-997-031 in 1 CARTON 24/11/2020
315 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 Drug M006 11/24/2020 12/31/2023

LABELER - CLINIQUE LABORATORIES LLC(044475127)

REGISTRANT - Estee Lauder Companies Inc.(790802086)

Establishment
Name Address ID/FEI Business Operations
Accupac, LLC 071609663 pack(49527-997)

Establishment
Name Address ID/FEI Business Operations
The Estee Lauder Inc 802599436 pack(49527-997)

Establishment
Name Address ID/FEI Business Operations
Vee Pak, LLC dba Voyant Beauty 874763303 manufacture(49527-997)

PRINCIPAL DISPLAY PANEL

acne

CLINIQUE

acne solutions

all-over clearing
treatment

oil-free

STEP 3

BENZOYL PEROXIDE
ACNE MEDICATION

ALL SKIN TYPES

1.7 FL.OZ.LIQ./50 ml ℮

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton