FDA.reportPublic FDA data

Natural Acne Solutions 3 Step Regimen

Manufacturer
Burt's Bees
Effective date
2016-04-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:45:47

Label at a glance#

ProductNatural Acne Solutions 3 Step Regimen
Active ingredientSALICYLIC ACID
Label structure22 sections

Indications and uses

PENETRATES PORES TO CONTROL ACNE. HELPS PREVENT THE DEVELOPMENT OF NEW BLEMISHES.

Dosage and administration

APPLY TO FACE IN THE MORNING AND EVENING AFTER CLEANSING. IF BOTHERSOME DRYNESS OCCURS, REDUCE TO ONCE A DAY OR EVERY OTHER DAY.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

SALICYLIC ACID 1.0%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

INDICATIONS & USAGE SECTION

PENETRATES PORES TO CONTROL ACNE.

HELPS PREVENT THE DEVELOPMENT OF NEW BLEMISHES

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY. USING OTHER TOPICAL ACNE MEDICATION AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children IF SWALLOWED, GET MEDICATL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

APPLY TO FACE IN THE MORNING AND EVENING AFTER CLEANSING. IF BOTHERSOME DRYNESS OCCURS, REDUCE TO ONCE A DAY OR EVERY OTHER DAY.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, GLYCERIN, STEARIC ACID, SUCROSE POLYSTEARATE, SALIX NIGRA (WILLOW) BARK EXTRACT, BEESWAX, CYMBOPOGON SCHOENANTHUS EXTRACT, HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF EXTRACT, HUMULUS LUPULUS (HOPS) EXTRACT, EQUISETUM HIEMALE EXTRACT, HYDRASTIS CANADENSIS (GOLDENSEAL) EXTRACT, EPILOBIUM FLEISCHERI EXTRACT, LECITHIN, CHONDRUS CRISPUS (CARAGEENAN), FRAGRANCE, GLUCOSE, XANTHAN GUM, SUCROSE, SUCROSE STEARATE, POTASSIUM SORBATE, SODIUM CHLORIDE, GLUCOSE OXIDASE, LACTOPEROXIDASE, PHENOXYETHANOL.

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

SALICYLIC ACID 1.0%

PURPOSE

OTC - PURPOSE SECTION

ACNE TREATMENT

USES

INDICATIONS & USAGE SECTION

PENETRATES PORES TO CONTROL ACNE.

HELPS PREVENT THE DEVELOPMENT OF NEW BLEMISHES.

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY. USING OTHER TOPICAL ACNE MEDICATION AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION WHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

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

WASH FACE IN THE MORNING AND EVENING AVOIDING THE EYE AREA. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, DECYL GLUCOSIDE, LAURYL GLUCOSIDE, SUCROSE LAURATE, SALIX NIGRA (WILLOW) BARK EXTRACT, COCO-BETAINE, BETAINE, BETA VULGARIS (BEET) ROOT EXTRACT, CENOTHERA BIENNIS (EVENING PRIMROSE) LEAF EXTRACT, SODIUM COCOYL HYDROLYZED SOY PROTEIN, HYDROXYPROPYLTRIMONIUM HONEY, GLYCERIN, GLYCERYL OLEATE, COCO GLUCOSIDE, FRAGRANCE, GLUCOSE, ALCOHOL DENAT., GLUCOSE OXIDASE, LACTOPEROXIDASE, CITRIC ACID, SODIUM CHLORIDE, PHENOXYETHANOL.

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 0.75%

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • Penetrates pores to control acne

Warnings

WARNINGS SECTION

For external use only. Using other topical acne medication at the same time or immediately following use of this product may increased dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help and contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to face in the morning and evening after cleansing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: alcohol denat., citrus medica limonum (lemon) peel oil, water, achillea millefolium extract, borago officinalis extract, calendula officinalis flower extract, carum petroselinum (parsley) extract, foeniculum vulgare (fennel) oil, salix nigra (willow) bark extract, melaleuca alternifolia (tea tree) leaf oil, eucalyptus globulus leaf oil, juniperus communis fruit oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BURTS BEES

Natural

ACNE SOLUTIONS

1 Purifying Gel Cleanser

2 Daily Moisturizing Lotion

3 Targeted Spot Treatment

3 Step Regimen Kit Salicylic Acid Acne Treatment from Willow Bark

Acne Regimen KitAcne Regimen Kit

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1789221{1 (145 ML) (salicylic acid 10 MG/ML Medicated Liquid Soap) / 1 (60 ML) (salicylic acid 10 MG/ML Topical Lotion) / 1 (7.5 ML) (salicylic acid 7.5 MG/ML Topical Solution) } PackGPCK2
248411salicylic acid 0.75 % Topical SolutionPSN2
1038982salicylic acid 1 % Medicated Liquid SoapPSN2
1789221salicylic acid 1 % Medicated Liquid Soap (145 ML) / salicylic acid 1 % Topical Lotion (60 ML) / salicylic acid 0.75 % Topical Solution (7.5 ML) PackPSN2
245199salicylic acid 1 % Topical LotionPSN2
1038982salicylic acid 10 MG/ML Medicated Liquid SoapSCD2
245199salicylic acid 10 MG/ML Topical LotionSCD2
248411salicylic acid 7.5 MG/ML Topical SolutionSCD2
1789221{1 (5 OZ) (salicylic acid 1 % Medicated Liquid Soap) / 1 (2 OZ) (salicylic acid 1 % Topical Lotion) / 1 (0.26 OZ) (salicylic acid 0.75 % Topical Solution) } PackSY2
248411salicylic acid 0.75 % Topical SolutionSY2
1038982salicylic acid 1 % Medicated Liquid SoapSY2
245199salicylic acid 1 % Topical LotionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
26052-035-102020-01-31C16284748780-19d75b9d0-77b6-f424-e053-dadaa90a57ce310198a7-eb46-57e6-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
26052-010-02Natural Acne Solutions 3 Step Regimen145 mL in 1 BOTTLE, PLASTICGEL1 mL in 1001 g in 100mL2
26052-011-03Natural Acne Solutions 3 Step Regimen7.5 g in 1 BOTTLE, WITH APPLICATORLIQUID1 g in 1000.75 g in 100g2
26052-012-01Natural Acne Solutions 3 Step Regimen55 g in 1 BOTTLE, PUMPLOTION1 g in 1001 g in 100g2
26052-035-10Natural Acne Solutions 3 Step Regimen1 in 1 BOXKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
26052-010NATURAL ACNE SOLUTIONS 3 STEP REGIMEN (SALICYLIC ACID) KIT [BURT'S BEES]2Legacy NDC20160426_310198a7-eb46-57e6-e054-00144ff88e88.zip
26052-011NATURAL ACNE SOLUTIONS 3 STEP REGIMEN (SALICYLIC ACID) KIT [BURT'S BEES]2Legacy NDC20160426_310198a7-eb46-57e6-e054-00144ff88e88.zip
26052-012NATURAL ACNE SOLUTIONS 3 STEP REGIMEN (SALICYLIC ACID) KIT [BURT'S BEES]2Legacy NDC20160426_310198a7-eb46-57e6-e054-00144ff88e88.zip
26052-035NATURAL ACNE SOLUTIONS 3 STEP REGIMEN (SALICYLIC ACID) KIT [BURT'S BEES]2Legacy NDC, 4 package rows20160426_310198a7-eb46-57e6-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 2 · 50 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
26052-03526052-035-10
26052-01026052-010-02
26052-01126052-011-03
26052-01226052-012-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 58 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL OLEATE4PC054V79PIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
SUCROSE LAURATE05Q7CD0E49IACT
COCO GLUCOSIDEICS790225BIACT
GLUCOSE OXIDASE0T8392U5N1IACT
GLYCERINPDC6A3C0OXIACT
HYDROXYPROPYLTRIMONIUM CHLORIDE FRAGMENTN30M4819DBIACT
BETA VULGARIS4G174V5051IACT
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW)1394NXB9L6IACT
ALCOHOL3K9958V90MIACT
LACTOPEROXIDASE BOVINE01UIN5OC49IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM CHLORIDE451W47IQ8XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
SALICYLIC ACIDO414PZ4LPZACTIB
SALIX NIGRA BARKQU52J3A5B3IACT
COCO-BETAINE03DH2IZ3FYIACT
BETAINE3SCV180C9WIACT
OENOTHERA BIENNIS LEAF153YBS895WIACT
WATER059QF0KO0RIACT
SALICYLIC ACIDO414PZ4LPZACTIB
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
LEMON OILI9GRO824LLIACT
BORAGO OFFICINALIS SEED2GXJ790US0IACT
PARSLEY OILIXK9N7RJ7JIACT
SALIX NIGRA BARKQU52J3A5B3IACT
TEA TREE OILVIF565UC2GIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
FENNEL OIL59AAO5F6HTIACT
JUNIPER BERRY OILSZH16H44UYIACT
ALCOHOL3K9958V90MIACT
ACHILLEA MILLEFOLIUM2FXJ6SW4PKIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
HAMAMELIS VIRGINIANA LEAFT07U1161SVIACT
LEVOGLUCOSE02833ISA66IACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
EPILOBIUM FLEISCHERI WHOLE8E2KLS8J8KIACT

Source Document#

Source XML · Source PDF

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3165a1c3-b39e-0faa-e054-00144ff8d46c310198a7-eb46-57e6-e054-00144ff88e882016-04-26WarningsExact identifier
spl id: 3165a1c3-b39e-0faa-e054-00144ff8d46c
spl set id: 310198a7-eb46-57e6-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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