FDA.reportPublic FDA data

SPOTLESS Acne Clearing Treatment

Manufacturer
Rodan & Fields
Effective date
2026-02-04
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:36:42

Label at a glance#

ProductSPOTLESS Acne Clearing Treatment
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Indications and uses

for the treatment of acne helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads

Dosage and administration

clean the skin thoroughly before applying this product dispense 1-2 pumps and cover the entire affected area with a thin, even layer one to three times daily do not rinse product off face wash hands after application to help avoid staining fabrics 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 docto...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl peroxide 2.5%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

  • for the treatment of acne
  • helps keep skin clear of new acne blemishes, acne pimples, blackheads and whiteheads

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

When using this product

OTC - WHEN USING SECTION

  • 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.
  • 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 the eyes, lips and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product

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

  • clean the skin thoroughly before applying this product
  • dispense 1-2 pumps and cover the entire affected area with a thin, even layer one to three times daily
  • do not rinse product off face
  • wash hands after application to help avoid staining fabrics
  • 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.

Other information

OTHER SAFETY INFORMATION

store between 15-30°C (59-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water/aqua/eau, glycereth-18 ethylhexanoate, glycereth-18, disiloxane, glycerin, butylene glycol, propanediol, acrylamide/sodium acryloyldimethyltaurate copolymer, allantoin, ascorbyl palmitate, bisabolol, myristyl alcohol, PCA, phytosteryl/octyldodecyl lauroyl glutamate, polygonum cuspidatum root extract, sodium hyaluronate, zingiber officinale (ginger) root extract, fragrance/parfum, carbomer, methyl methacrylate crosspolymer, cetyl hydroxyethylcellulose, hydroxyphenyl propamidobenzoic acid, polyglyceryl-2 isostearate, polysorbate 80, sorbitan oleate, xanthan gum, diethylhexyl sodium sulfosuccinate, isohexadecane, dimethyl isosorbide, tocopherol, citric acid, sodium citrate, sodium hydroxide, caprylyl glycol, decylene glycol, hexylene glycol, pentylene glycol, 1,2-hexanediol, ethylhexylglycerin, hydroxyacetophenone, phenoxyethanol, citral, citronellol, limonene, linalool, carvone, citrus aurantium peel oil, mentha viridis (spearmint) leaf oil, pinene, mica, tin oxide, titanium dioxide (CI 77891), blue 1 (CI 42090), ext. violet 2 (CI 60730), red 33 (CI 17200)

Questions?

OTC - QUESTIONS SECTION

1-888-995-5656

Principal Display Panel - 50 mL Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN+FIELDS

SPOTLESS

ACNE CLEARING TREATMENT
Benzoyl Peroxide Lotion*

50 mL / 1.7 Fl. Oz U.S.

Principal Display Panel - 50 mL Carton Label
Principal Display Panel - 50 mL Carton Label

Principal Display Panel - 50 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN+FIELDS
SPOTLESS

ACNE
CLEARING
TREATMENT

2

Principal Display Panel - 50 mL Tube Label
Principal Display Panel - 50 mL Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
200009benzoyl peroxide 2.5 % Topical LotionPSN7
200009benzoyl peroxide 25 MG/ML Topical LotionSCD7
200009benzoyl peroxide 2.5 % Topical LotionSY7

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130884164015397GTIN-13: 0884164015397
EAN-13: 0884164015397
GTIN-12: 884164015397
UPC-A: 884164015397
GTIN storage (14 digits): 00884164015397		spo02-0007-01.jpg

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
14222-1620-1SPOTLESS Acne Clearing Treatment1 in 1 CARTONLOTION17
14222-1620-1SPOTLESS Acne Clearing Treatment50 mL in 1 BOTTLE, PUMPLOTION507

Products#

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

DailyMed product names page 1 of 2 · 56 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14222-162014222-1620-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 55 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB
WATER059QF0KO0RIACT
GLYCERETH-18 ETHYLHEXANOATEIWS58C6V2YIACT
GLYCERETH-18SA5E43C17CIACT
HEXAMETHYLDISILOXANED7M4659BPUIACT
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PROPANEDIOL5965N8W85TIACT
ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (120000 MPA.S AT 1%)5F4963KLHSIACT
ALLANTOIN344S277G0ZIACT
ASCORBYL PALMITATEQN83US2B0NIACT
LEVOMENOL24WE03BX2TIACT
MYRISTYL ALCOHOLV42034O9PUIACT
PIDOLIC ACIDSZB83O1W42IACT
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE65954KGO9QIACT
REYNOUTRIA JAPONICA ROOT7TRV45YZF7IACT
HYALURONATE SODIUMYSE9PPT4THIACT
GINGERC5529G5JPQIACT
POLYACRYLIC ACID (800000 MW)D0I6NSZ87UIACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
CETYL HYDROXYETHYLCELLULOSE (350000 MW)T7SWE4S2TTIACT
HYDROXYPHENYL PROPAMIDOBENZOIC ACID25KRT26H77IACT
POLYGLYCERYL-2 ISOSTEARATE7B8OE71MQCIACT
POLYSORBATE 806OZP39ZG8HIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
XANTHAN GUMTTV12P4NEEIACT
DOCUSATE SODIUMF05Q2T2JA0IACT
ISOHEXADECANE918X1OUF1EIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
TOCOPHEROLR0ZB2556P8IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM HYDROXIDE55X04QC32IIACT
CAPRYLYL GLYCOL00YIU5438UIACT
DECYLENE GLYCOLS57M60MI88IACT
HEXYLENE GLYCOLKEH0A3F75JIACT
PENTYLENE GLYCOL50C1307PZGIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT

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
SPOTLESS Acne Clearing TreatmentBENZOYL PEROXIDERodan & Fields3d4ef4ce-9be3-436a-9f93-c01caa93d1a82026-02-04WarningsExact identifier
ndc (package): 14222-1620-1
ndc (product): 14222-1620
ndc11 (package): 14222162001
spl id: 0aa7bb65-4878-4dd7-9213-2fcf11a9501d
spl set id: 3d4ef4ce-9be3-436a-9f93-c01caa93d1a8

Reported adverse events (FAERS/openFDA)#

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