ACNE SOLUTIONS ALL-OVER CLEARING TREATMENT- benzoyl peroxide lotion

ACNE SOLUTIONS by

Drug Labeling and Warnings

ACNE SOLUTIONS by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., Accupac, LLC, The Estee Lauder Inc, Vee Pak, LLC dba Voyant Beauty, PALC, Northtec Keystone. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT: BENZOYL PEROXIDE 2.5%

Purpose

Acne Treatment

Directions

DIRECTIONS:

• CLEANS SKIN THOROUGHLY BEFORE APPLYING THIS PRODUCT
• COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES DAILY
• BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY, THEN GRADUALLY INCREASE TO TWO OR THREE TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR
• IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DOY OR EVERY OTHER DAY
• IF GOING OUTSIDE, USE A SUNSCREEN AFTER APPLYING THIS PRODUCT. IF IRRITATION OR SENSITIVITY DEVELOPS, DISCONTINUE USE OF BOTH PRODUCTS AND CONSULT A DOCTOR
• FOR BEST RESULTS, USE AFTER ACNE SOLUTIONS CLEANSING FOAM AND CLARIFYING LOTION

Uses

Treats Acne

Clears acne blemishes

Helps prevent development of new acne blemishes

WARNINGS

WARNING: FOR EXTERNAL USE ONLY

DO NOT USE IF YOU

• HAVE VERY SENSITIVE SKIN
• ARE SENSITIVE TO BENZOYL PEROXIDE

WHEN USING THIS PRODUCT

• SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THIS TIME. IF IRRITATION OCCURS, USE ONLY ONE TOPICAL ACNE MEDICATION AT AT TIME
• AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN
• AVOID CONTACT WITH THE EYES, LIPS, AND MOUTH
• AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THIS PRODUCT
• SKIN IRRITATION MAY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHING, PEELING OR POSSIBLY SWELLING. IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION

STOP USE AND ASK A DOCTOR IF

• IRRITATION BECOMES SEVERE

KEEP OUT OF REACH OF CHILDREN

IF SWALLOWED, GET MECICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Inactive ingredients

water\aqua\eau∙cyclopentasiloxane∙butylene glycol∙cyclohexasiloxane∙ceteareth-20∙dimethicone∙sucrose∙camellia sinensis (green tea) leaf extract∙hordeum vulgare (barley) extract\extrait d'orge∙acetyl glucosamine∙lactobacillus ferment∙poria cocos sclerotium extract∙polymethyl methacrylate∙laminaria saccharina extract∙gentiana lutea (gentian) root extract∙astrocaryum murumuru seed butter∙acrylamide/sodium acryloyldimethyltaurate copolymer∙myristyl alcohol∙glycerin∙zeolite∙algae extract∙linoleic acid∙10-hydroxydecanoic acid∙cucumis sativus (cucumber) fruit extract∙caffeine∙ cholesterol∙tocopheryl acetate∙bisabolol∙polysorbate 80∙sodium hyaluronate∙propylene glycol dicaprate∙capryloyl glycine∙helianthus annuus (sunflower) seed extract∙quaternium-22∙caprylyl glycol∙isohexadecane∙xanthan gum∙disodiumedta∙chloroxylenol∙phenoxyethanol∙titanium dioxide (ci 77891) [iln47611]

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

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 ℮

INGREDIENTS AND APPEARANCE

ACNE SOLUTIONS  ALL-OVER CLEARING TREATMENT
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-117
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	25 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
1	NDC: 49527-117-01	1 in 1 CARTON	12/21/2023
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49527-117-02	1 in 1 CARTON	12/21/2023
2		30 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 49527-117-03	1 in 1 CARTON	12/21/2023
3		15 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	12/21/2023

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, LLC		071609663	pack(49527-117)

Establishment
Name	Address	ID/FEI	Business Operations
The Estee Lauder Inc		802599436	pack(49527-117)

Establishment
Name	Address	ID/FEI	Business Operations
Vee Pak, LLC dba Voyant Beauty		874763303	manufacture(49527-117)

Establishment
Name	Address	ID/FEI	Business Operations
PALC		078364654	pack(49527-117) , label(49527-117)

Establishment
Name	Address	ID/FEI	Business Operations
Northtec Keystone		949264774	pack(49527-117) , label(49527-117)