Breakout Clearing Foaming Wash

Manufacturer: Dermalogica | McKenna
Effective date: 2024-12-24
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:49:20

Label at a glance#

ProductBreakout Clearing Foaming Wash

Active ingredientSalicylic Acid

Label structure9 sections

Dosage and administration

Morning and night, work a pea-sized amount into a lather in wet hands. Apply to dampened face and neck, massaging in circular motions while concentrating on areas of congestion and oiliness. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two daily. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. Avoid eye ar...

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

Salicylic Acid (0.5%).

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

around eye area. If contact occurs, flush thoroughly with water.

When using this product

OTC - WHEN USING SECTION

skin irritation and dryness are 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.

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

Morning and night, work a pea-sized amount into a lather in wet hands.
Apply to dampened face and neck, massaging in circular motions while concentrating on areas of congestion and oiliness.
Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two daily.
If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Avoid eye area.
Rinse thoroughly with warm water.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Cocamidopropyl Betaine, Sodium Lauroyl Methyl Isethionate, Acrylates/Beheneth-25 Methacrylate Copolymer, Polysorbate 20, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Oleanolic Acid, Butylene Glycol, Enantia Chlorantha Bark Extract, Disodium Cocoamphodiacetate, Spiraea Ulmaria Extract, Camellia Sinensis Leaf Extract, Porphyra Umbilicalis Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol.

Questions or comments

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 295 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

breakout clearing
foaming
wash

dermalogica
clear start

deep cleans + purifies

10 US FL OZ / 295 mL ℮

PRINCIPAL DISPLAY PANEL - 295 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68479-101-00	2022-07-13	C162847	48780-1	9d75b9d0-d666-f424-e053-dadaa90a57ce	Breakout Clearing Foaming Wash
68479-101-01	2022-07-13	C162847	48780-1	9d75b9d0-d666-f424-e053-dadaa90a57ce	Breakout Clearing Foaming Wash
68479-101-02	2022-07-13	C162847	48780-1	9d75b9d0-d666-f424-e053-dadaa90a57ce	Breakout Clearing Foaming Wash
68479-101-00	2020-01-31	C162847	48780-1	9d75b9d0-d666-f424-e053-dadaa90a57ce	Breakout Clearing Foaming Wash
68479-101-01	2020-01-31	C162847	48780-1	9d75b9d0-d666-f424-e053-dadaa90a57ce	Breakout Clearing Foaming Wash
68479-101-02	2020-01-31	C162847	48780-1	9d75b9d0-d666-f424-e053-dadaa90a57ce	Breakout Clearing Foaming Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68479-101-00	Breakout Clearing Foaming Wash	2 mL in 1 POUCH	LIQUID	2	4
68479-101-01	Breakout Clearing Foaming Wash	50 mL in 1 BOTTLE	LIQUID	50	4
68479-101-02	Breakout Clearing Foaming Wash	177 mL in 1 BOTTLE	LIQUID	177	4
68479-101-02	Breakout Clearing Foaming Wash	1 in 1 CARTON	LIQUID	1	4
68479-101-03	Breakout Clearing Foaming Wash	295 mL in 1 BOTTLE	LIQUID	295	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68479-101	BREAKOUT CLEARING FOAMING WASH (SALICYLIC ACID) LIQUID [DERMALOGICA]	4	Current NDC, Legacy NDC, 5 package rows	20241228_e55d212b-7687-47fd-86ec-f8709804dd04.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Salicylic Acid	ACTIVE INGREDIENT	O414PZ4LPZ	2
Salicylic Acid	ACTIVE MOIETY	O414PZ4LPZ	2
ANNICKIA CHLORANTHA BARK	INACTIVE INGREDIENT	H70115MP4A	2
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	2
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	2
DISODIUM COCOAMPHODIACETATE	INACTIVE INGREDIENT	18L9G3U51M	2
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	2
FILIPENDULA ULMARIA ROOT	INACTIVE INGREDIENT	997724QNDS	2
GLYCYRRHIZA GLABRA	INACTIVE INGREDIENT	2788Z9758H	2
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	2
LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	2
OLEANOLIC ACID	INACTIVE INGREDIENT	6SMK8R7TGJ	2
ORANGE OIL	INACTIVE INGREDIENT	AKN3KSD11B	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	2
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	2
PORPHYRA UMBILICALIS	INACTIVE INGREDIENT	14AN0J70WO	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	2
SODIUM LAUROYL METHYL ISETHIONATE	INACTIVE INGREDIENT	II6VCD3S6R	2
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

Breakout Clearing Foaming Wash
Salicylic Acid
WATER
COCAMIDOPROPYL BETAINE
SODIUM LAUROYL METHYL ISETHIONATE
POLYSORBATE 20
TEA TREE OIL
ORANGE OIL, COLD PRESSED
LAVENDER OIL
OLEANOLIC ACID
BUTYLENE GLYCOL
ANNICKIA CHLORANTHA BARK
DISODIUM COCOAMPHODIACETATE
FILIPENDULA ULMARIA ROOT
GREEN TEA LEAF
PORPHYRA UMBILICALIS
GLYCYRRHIZA GLABRA
SODIUM HYDROXIDE
ETHYLHEXYLGLYCERIN
PHENOXYETHANOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68479-101	68479-101-02, 68479-101-01, 68479-101-00, 68479-101-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Salicylic Acid	O414PZ4LPZ	ACTIB
WATER	059QF0KO0R	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
SODIUM LAUROYL METHYL ISETHIONATE	II6VCD3S6R	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
TEA TREE OIL	VIF565UC2G	IACT
ORANGE OIL, COLD PRESSED	AKN3KSD11B	IACT
LAVENDER OIL	ZBP1YXW0H8	IACT
OLEANOLIC ACID	6SMK8R7TGJ	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
ANNICKIA CHLORANTHA BARK	H70115MP4A	IACT
DISODIUM COCOAMPHODIACETATE	18L9G3U51M	IACT
FILIPENDULA ULMARIA ROOT	997724QNDS	IACT
GREEN TEA LEAF	W2ZU1RY8B0	IACT
PORPHYRA UMBILICALIS	14AN0J70WO	IACT
GLYCYRRHIZA GLABRA	2788Z9758H	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
ETHYLHEXYLGLYCERIN	147D247K3P	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT

Source Document#

Source XML · Source PDF

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 2 · 100 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LIQUID / TOPICAL	ADJ PH		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
BUTYLENE GLYCOL	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TOPICAL		1400 mg	Exact identifier — unii+route 5 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SOLUTION / TOPICAL	15 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	GEL / TOPICAL	5 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	LOTION / TOPICAL		2000 mg	Exact identifier — unii+route 45 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SOLUTION / TOPICAL	15 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii+route 30 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / TOPICAL	3.7 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SOAP / TOPICAL	0.02 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	GEL / TOPICAL	5 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
LAVENDER OIL	LAVENDER OIL	ZBP1YXW0H8	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route 5 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii+route 30 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	EMULSION / TOPICAL	2 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	EMULSION / TOPICAL	2 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CLOTH / TOPICAL	NA		Exact identifier — unii+route 45 equally ranked IID candidates
LAVENDER OIL	LAVENDER OIL	ZBP1YXW0H8	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route 5 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii+route 30 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / TOPICAL	3.7 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
BUTYLENE GLYCOL	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TOPICAL		1400 mg	Exact identifier — unii+route 5 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii+route 30 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	LOTION / TOPICAL		2000 mg	Exact identifier — unii+route 45 equally ranked IID candidates
ORANGE OIL	ORANGE OIL, COLD PRESSED	AKN3KSD11B	LIQUID / ORAL	50 mg		Exact identifier — unii+dosage form 5 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CREAM / TOPICAL		108 mg	Exact identifier — unii+route 45 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM, AUGMENTED / TOPICAL		10 mg	Exact identifier — unii+route 30 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LIQUID / TOPICAL	ADJ PH		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM, AUGMENTED / TOPICAL		10 mg	Exact identifier — unii+route 30 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	EMULSION / TOPICAL	2 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
DISODIUM COCOAMPHODIACETATE	DISODIUM COCOAMPHODIACETATE	18L9G3U51M	SHAMPOO, SUSPENSION / TOPICAL	5 %w/v		Exact identifier — unii+route 5 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LIQUID / TOPICAL	ADJ PH		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii+route 30 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii+route 30 equally ranked IID candidates
BUTYLENE GLYCOL	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TOPICAL		1400 mg	Exact identifier — unii+route 5 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
BUTYLENE GLYCOL	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TOPICAL		1400 mg	Exact identifier — unii+route 5 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CREAM / TOPICAL		108 mg	Exact identifier — unii+route 45 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	LOTION / TOPICAL		2000 mg	Exact identifier — unii+route 45 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
DISODIUM COCOAMPHODIACETATE	DISODIUM COCOAMPHODIACETATE	18L9G3U51M	SHAMPOO, SUSPENSION / TOPICAL	5 %w/v		Exact identifier — unii+route 5 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	GEL / TOPICAL	5 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
ORANGE OIL	ORANGE OIL, COLD PRESSED	AKN3KSD11B	LIQUID / ORAL	50 mg		Exact identifier — unii+dosage form 5 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LIQUID / TOPICAL	ADJ PH		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CREAM / TOPICAL		108 mg	Exact identifier — unii+route 45 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CREAM / TOPICAL		108 mg	Exact identifier — unii+route 45 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CLOTH / TOPICAL	NA		Exact identifier — unii+route 45 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii+route 30 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM, AUGMENTED / TOPICAL		10 mg	Exact identifier — unii+route 30 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	AEROSOL, FOAM / TOPICAL	3.7 %w/w		Exact identifier — unii+route 45 equally ranked IID candidates
LAVENDER OIL	LAVENDER OIL	ZBP1YXW0H8	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii+route 5 equally ranked IID candidates
BUTYLENE GLYCOL	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TOPICAL		1400 mg	Exact identifier — unii+route 5 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii+route 30 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	GEL / TOPICAL	5 %w/w		Exact identifier — unii+route 45 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
Breakout Clearing Foaming Wash	SALICYLIC ACID	Dermalogica	e55d212b-7687-47fd-86ec-f8709804dd04	2024-12-24	Warnings	Exact identifier ndc (package): 68479-101-03 ndc (package): 68479-101-00 ndc (package): 68479-101-02 ndc (package): 68479-101-01 ndc (product): 68479-101 ndc11 (package): 68479010102 ndc11 (package): 68479010103 ndc11 (package): 68479010101 ndc11 (package): 68479010100 spl id: 315524e4-cb5e-4afc-86d8-8d9a00c26ee1 spl set id: e55d212b-7687-47fd-86ec-f8709804dd04

Reported adverse events (FAERS/openFDA)#

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