FDA.reportPublic FDA data

Proactivplus Skin Smoothing Exfoliator

Manufacturer
Alchemee, LLC | Apex International Mfg LLC | Vee Pak, LLC dba Voyant Beauty
Effective date
2026-01-07
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:31:50

Label at a glance#

ProductProactivplus Skin Smoothing Exfoliator
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Dosage and administration

Sensitivity Test for a New User.  Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. cover the entire affected area with a thin layer and rinse thoroughly 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...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl peroxide 2.5%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

for the management of acne

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with 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.

OTC - DO NOT USE SECTION

Do not useif you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation becomes severe.

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

  • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
  • cover the entire affected area with a thin layer and rinse thoroughlyone 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 day or every other day
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sodium cocoyl isethionate, glycerin, paraffin, lauryl/myristyl benzoate, coconut acid, butylene glycol, acrylates/C10-30 alkyl acrylate crosspolymer, phenoxyethanol, sodium isethionate, sodium hydroxide, fragrance, dimethicone, linoleic acid, ethylhexylglycerin, glycolic acid, linolenic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-950-4695

SPL UNCLASSIFIED SECTION

Distributed by Alchemee LLC, Santa Monica, CA 90401
Made in the USA of Foreign and Domestic Components
Questions? 1-800-950-4695 • proactiv.com • Proactiv is a
registered trademark of Taro Pharmaceuticals U.S.A., Inc.

PRINCIPAL DISPLAY PANEL - 60 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

proactiv+

Skin
Smoothing
Exfoliator

2 FL. OZ. (60 mL)

benzoyl peroxide
acne treatment

unit carton image
unit carton image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11410-011-68Proactivplus Skin Smoothing Exfoliator1 in 1 BOXLOTION110
11410-011-68Proactivplus Skin Smoothing Exfoliator177.4 mL in 1 TUBELOTION177.410
11410-011-82Proactivplus Skin Smoothing Exfoliator1 in 1 BOXLOTION110
11410-011-82Proactivplus Skin Smoothing Exfoliator60 mL in 1 TUBELOTION6010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GM1
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GM1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995L1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCOLIC ACIDINACTIVE INGREDIENT0WT12SX38S1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR71
LAURYL/MYRISTYL BENZOATEINACTIVE INGREDIENTN5RS934G6D1
LINOLEIC ACIDINACTIVE INGREDIENT9KJL21T0QJ1
LINOLENIC ACIDINACTIVE INGREDIENT0RBV727H711
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
SODIUM COCOYL ISETHIONATEINACTIVE INGREDIENT518XTE84931
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11410-01111410-011-68, 11410-011-82

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
GLYCERINPDC6A3C0OXIACT
LAURYL/MYRISTYL BENZOATEN5RS934G6DIACT
COCONUT ACID40U37V505DIACT
LINOLEIC ACID9KJL21T0QJIACT
LINOLENIC ACID0RBV727H71IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
GLYCOLIC ACID0WT12SX38SIACT
SODIUM ISETHIONATE3R36J71C17IACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PARAFFINI9O0E3H2ZEIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

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 1 · 33 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7PASTE / TOPICAL2.5 %w/wExact identifier — unii+route
15 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7OINTMENT / TOPICAL94 %w/wExact identifier — unii+route
15 equally ranked IID candidates
SODIUM COCOYL ISETHIONATESODIUM COCOYL ISETHIONATE518XTE8493SHAMPOO / TOPICAL1 %w/wExact identifier — unii+route
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7OINTMENT / TOPICAL94 %w/wExact identifier — unii+route
15 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7GEL / TOPICAL26 %w/wExact identifier — unii+route
15 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7CREAM / TOPICAL54.5 %w/wExact identifier — unii+route
15 equally ranked IID candidates
SODIUM COCOYL ISETHIONATESODIUM COCOYL ISETHIONATE518XTE8493SHAMPOO / TOPICAL1 %w/wExact identifier — unii+route
3 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILOTION / TOPICAL21 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7CREAM / TOPICAL54.5 %w/wExact identifier — unii+route
15 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
3 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7GEL / TOPICAL26 %w/wExact identifier — unii+route
15 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7PASTE / TOPICAL2.5 %w/wExact identifier — unii+route
15 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii+route
3 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7OINTMENT / TOPICAL94 %w/wExact identifier — unii+route
15 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7PASTE / TOPICAL2.5 %w/wExact identifier — unii+route
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7CREAM / TOPICAL54.5 %w/wExact identifier — unii+route
15 equally ranked IID candidates
SODIUM COCOYL ISETHIONATESODIUM COCOYL ISETHIONATE518XTE8493SHAMPOO / TOPICAL1 %w/wExact identifier — unii+route
3 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7TAPE / TOPICALNAExact identifier — unii+route
15 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7TAPE / TOPICALNAExact identifier — unii+route
15 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7TAPE / TOPICALNAExact identifier — unii+route
15 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7GEL / TOPICAL26 %w/wExact identifier — unii+route
15 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILOTION / TOPICAL21 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILOTION / TOPICAL21 mgExact identifier — unii+route+dosage form
3 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Proactivplus Skin Smoothing ExfoliatorBENZOYL PEROXIDEAlchemee, LLCb56b63d6-5635-4fd4-9517-8b08c3cbf9aa2026-01-07WarningsExact identifier
ndc (package): 11410-011-82
ndc (package): 11410-011-68
ndc (product): 11410-011
ndc11 (package): 11410001182
ndc11 (package): 11410001168
spl id: 47d2927b-b68b-90ff-e063-6294a90a34f6
spl set id: b56b63d6-5635-4fd4-9517-8b08c3cbf9aa
Proactiv Plus KitSOLUTIONS KITAlchemee, LLC1bbe19ff-0bc8-7b8b-e063-6394a90aa7f42026-01-07WarningsExact identifier
ndc (package): 11410-011-82
ndc11 (package): 11410001182

Reported adverse events (FAERS/openFDA)#

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