Breakout Clearing Daytime Treatment

Manufacturer: Dermalogica, Inc. | PakLab | Diamond Wipes
Effective date: 2015-11-24
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:44:12

Label at a glance#

ProductBreakout Clearing Daytime Treatment

Active ingredientBenzoyl Peroxide

Label structure10 sections

Dosage and administration

Cleanse the skin thoroughly before applying. Cover the affected area with a thin layer 1 to 3 times a day. Because too much drying of the skin may occur, start with one application daily, and then gradually increase to 2 or 3 times daily if needed or as directed by a physician. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. If going outside use a sunscreen. Allow Dayt...

Storage and handling

Protect this product from excessive heat and direct sun.

Contacts and useful links#

PhoneLabel contact1-800-831-5150

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 treatment of acne

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

in or near eyes
on broken skin
on lips or large areas of the body
if you have very sensitive skin
if you are sensitive to benzoyl peroxide

When using this product

OTC - WHEN USING SECTION

apply to affected areas only
avoid unnecessary sun exposure and use sunscreen
This product may bleach hair or dyed fabrics.
Using other topical acne products at the same time or immediately following the use of this product may increase dryness or irritation of the skin. Only one product should be used unless directed by a physican.

Stop use and ask a physician

OTC - STOP USE SECTION

if too much skin irritation or sensitivity develops or increases

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

Cleanse the skin thoroughly before applying.
Cover the affected area with a thin layer 1 to 3 times a day.
Because too much drying of the skin may occur, start with one application daily, and then gradually increase to 2 or 3 times daily if needed or as directed by a physician.
If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
If going outside use a sunscreen. Allow Daytime Treatment to dry then follow directions of the sunscreen labeling.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Niacinamide, Glycerin, Dimethicone, Helianthus Annuus (Sunflower) Seed Oil, Cucumis Sativus (Cucumber) Fruit Extract, Lavandula Angustifolia (Lavender) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Boerhavia Diffusa Root Extract, Sodium Acrylates Copolymer, Lecithin, Galactoarabinan, Glyceryl Polyacrylate, Polyisobutene, Dipotassium Glycyrrhizate, Butylene Glycol, Xanthan Gum, Polyacrylate-13, 1,2-Hexanediol, Polysorbate 20, Disodium EDTA, Citric Acid, Ethylhexylglycerin, Phenoxyethanol.

Other information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

Questions or comments

OTC - QUESTIONS SECTION

Call toll free 1-800-831-5150 in the US

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dermalogica^®
clear

2.5%
benzoyl
peroxide

Breakout Clearing
Daytime
Treatment

2.0 US Fl. Oz. / 60 mL e

Principal Display Panel - 60 mL Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
200009	benzoyl peroxide 2.5 % Topical Lotion	PSN	2
200009	benzoyl peroxide 25 MG/ML Topical Lotion	SCD	2
200009	benzoyl peroxide 2.5 % Topical Lotion	SY	2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a46239a7-5963-4008-8cbb-6b9000f497eb	Product name	1	20250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19	Product name	3	20250317
d9d61457-6a5a-41fc-b418-e5479a2904b7	Product name	2	20230303
32012d5c-25ac-49c7-9d4c-1313177fff7c	Product name	1	20230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06e	Product name	1	20220128
4a7d44fe-774d-404b-aad0-8a90fe78375a	Product name	4	20211025
3f45980c-c196-47e5-0e5e-48b7c57327c5	Product name	5	20200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27b	Product name	3	20200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992	Product name	4	20190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfa	Product name	1	20170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68479-160-00	2020-01-31	C162847	48780-1	9d75b9d0-d660-f424-e053-dadaa90a57ce	Breakout Clearing Daytime Treatment
68479-160-01	2020-01-31	C162847	48780-1	9d75b9d0-d660-f424-e053-dadaa90a57ce	Breakout Clearing Daytime Treatment
68479-160-02	2020-01-31	C162847	48780-1	9d75b9d0-d660-f424-e053-dadaa90a57ce	Breakout Clearing Daytime Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68479-160-00	Breakout Clearing Daytime Treatment	2 mL in 1 POUCH	LOTION	2	2
68479-160-01	Breakout Clearing Daytime Treatment	14 mL in 1 TUBE	LOTION	14	2
68479-160-02	Breakout Clearing Daytime Treatment	1 in 1 CARTON	LOTION	1	2
68479-160-02	Breakout Clearing Daytime Treatment	60 mL in 1 TUBE	LOTION	60	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68479-160	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2	Legacy NDC, 4 package rows	20151125_836ca02b-098d-456e-9a88-bdaf69656cab.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Benzoyl Peroxide	ACTIVE INGREDIENT	W9WZN9A0GM	2
Benzoyl Peroxide	ACTIVE MOIETY	W9WZN9A0GM	2
1,2-Hexanediol	INACTIVE INGREDIENT	TR046Y3K1G	2
Boerhavia Diffusa Root	INACTIVE INGREDIENT	KR0SR09KYL	2
Butylene Glycol	INACTIVE INGREDIENT	3XUS85K0RA	2
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	2
Cucumber	INACTIVE INGREDIENT	YY7C30VXJT	2
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	2
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	2
Egg Phospholipids	INACTIVE INGREDIENT	1Z74184RGV	2
Ethylhexylglycerin	INACTIVE INGREDIENT	147D247K3P	2
Galactoarabinan	INACTIVE INGREDIENT	SL4SX1O487	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	2
Glycyrrhizinate Dipotassium	INACTIVE INGREDIENT	CA2Y0FE3FX	2
Lavandula Angustifolia Flowering Top	INACTIVE INGREDIENT	9YT4B71U8P	2
Niacinamide	INACTIVE INGREDIENT	25X51I8RD4	2
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	2
Polyisobutylene (1300 MW)	INACTIVE INGREDIENT	241BN7J12Y	2
Polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	2
Rosemary	INACTIVE INGREDIENT	IJ67X351P9	2
Sunflower Oil	INACTIVE INGREDIENT	3W1JG795YI	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	2

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

Breakout Clearing Daytime Treatment
Benzoyl Peroxide
Water
Niacinamide
Glycerin
Dimethicone
Sunflower Oil
Cucumber
Lavandula Angustifolia Flowering Top
Rosemary
Boerhavia Diffusa Root
Glycyrrhizinate Dipotassium
Egg Phospholipids
Galactoarabinan
Polyisobutylene (1300 MW)
Butylene Glycol
Xanthan Gum
1,2-Hexanediol
Polysorbate 20
Edetate Disodium
Citric Acid Monohydrate
Phenoxyethanol
Ethylhexylglycerin

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68479-160	68479-160-02, 68479-160-01, 68479-160-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Benzoyl Peroxide	W9WZN9A0GM	ACTIB
Water	059QF0KO0R	IACT
Niacinamide	25X51I8RD4	IACT
Glycerin	PDC6A3C0OX	IACT
Dimethicone	92RU3N3Y1O	IACT
Sunflower Oil	3W1JG795YI	IACT
Cucumber	YY7C30VXJT	IACT
Lavandula Angustifolia Flowering Top	9YT4B71U8P	IACT
Rosemary	IJ67X351P9	IACT
Boerhavia Diffusa Root	KR0SR09KYL	IACT
Glycyrrhizinate Dipotassium	CA2Y0FE3FX	IACT
Egg Phospholipids	1Z74184RGV	IACT
Galactoarabinan	SL4SX1O487	IACT
Polyisobutylene (1300 MW)	241BN7J12Y	IACT
Butylene Glycol	3XUS85K0RA	IACT
Xanthan Gum	TTV12P4NEE	IACT
1,2-Hexanediol	TR046Y3K1G	IACT
Polysorbate 20	7T1F30V5YH	IACT
Edetate Disodium	7FLD91C86K	IACT
Citric Acid Monohydrate	2968PHW8QP	IACT
Phenoxyethanol	HIE492ZZ3T	IACT
Ethylhexylglycerin	147D247K3P	IACT

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 6 · 314 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	LOTION / TOPICAL		2000 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRABURSAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / INTRAVENOUS	0.2 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / RESPIRATORY (INHALATION)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOAP / TOPICAL	0.76 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / TOPICAL	0.11 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / OPHTHALMIC	0.06 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	LOTION / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	JELLY / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 88 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TAMPON / VAGINAL	64.8 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRA-ARTICULAR	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	POWDER, FOR SUSPENSION / ORAL		285 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION / ORAL		26208 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INFILTRATION		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	EMULSION / TOPICAL	2 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SUSPENSION, EXTENDED RELEASE / ORAL	140.8 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, FILM COATED / ORAL	4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	DROPS / ORAL	300 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	GRANULE, FOR SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Niacinamide	NIACINAMIDE	25X51I8RD4	INJECTION / INTRAVENOUS	2.5 %w/v		Exact identifier — unii candidate 4 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TROCHE / ORAL	12 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	ELIXIR / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 77 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, CHEWABLE / ORAL	7 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / RECTAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / AURICULAR (OTIC)	0.2 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		60 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / INTRAVENOUS		10 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAVENOUS		396 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TROCHE / ORAL		948 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION/ DROPS / TOPICAL	0.01 %w/v		Exact identifier — unii candidate 88 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAVENOUS	2068 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / SUBCUTANEOUS		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 29 equally ranked IID candidates
Citric Acid Monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INFILTRATION	0.02 %w/v		Exact identifier — unii candidate 88 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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d00ecad9-7ca8-4d61-a84b-3894c8f9a99e			836ca02b-098d-456e-9a88-bdaf69656cab	2015-11-24	Warnings	Exact identifier spl id: d00ecad9-7ca8-4d61-a84b-3894c8f9a99e spl set id: 836ca02b-098d-456e-9a88-bdaf69656cab

Reported adverse events (FAERS/openFDA)#

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