FDA.reportPublic FDA data

SPOTLESS Regimen for Acne, Blemishes and Breakouts

Manufacturer
Rodan & Fields
Effective date
2026-02-04
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:36:56

Label at a glance#

ProductSPOTLESS REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS
Active ingredientBENZOYL PEROXIDE
Label structure24 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

wet skin with lukewarm water using fingertips, apply a thin, even layer and massage over entire face for 90 seconds, avoiding all contact with eyes rinse thoroughly and pat dry use once daily and increase to twice daily as tolerated 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 ti...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DAILY ACNE WASH

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl peroxide 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

  • wet skin with lukewarm water
  • using fingertips, apply a thin, even layer and massage over entire face for 90 seconds, avoiding all contact with eyes
  • rinse thoroughly and pat dry
  • use once daily and increase to twice daily as tolerated
  • 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, polyacrylamide, C13-14 isoalkane, jojoba esters, carbomer, diethylhexyl sodium sulfosuccinate, cocamidopropyl betaine, laureth-7, sodium chloride, sodium citrate, sodium hydroxide, propanediol, ethylhexylglycerin, phenoxyethanol, sodium benzoate

Questions?

OTC - QUESTIONS SECTION

1-888-995-5656

SPL UNCLASSIFIED SECTION

ACNE CLEARING TREATMENT

Drug Facts

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 - Kit Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN+FIELDS

SPOTLESS

REGIMEN FOR
ACNE, BLEMISHES
AND BREAKOUTS

DESIGNED FOR
TEENS AND YOUNG ADULTS

  • Eliminates acne-causing bacteria
  • Helps clear blackheads, whiteheads
    and pimples
  • Helps prevent new blemishes
    from forming
  • Reduces shine

DEVELOPED BY STANFORD-TRAINED
DERMATOLOGISTS DR.KATIE RODAN
AND DR.KATHY FIELDS

Daily Acne Wash

Benzoyl Peroxide Cream

125 mL/4.2 Fl. Oz. U.S.

Acne Clearing Treatment

Benzoyl Peroxide Lotion*

50 mL/1.7 Fl. Oz. U.S.

Figure
Figure

Principal Display Panel - Daily Acne Wash Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN+FIELDS
SPOTLESS

DAILY
ACNE
WASH

1

Figure
Figure

Principal Display Panel - Acne Clearing Treatment Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN+FIELDS
SPOTLESS

ACNE
CLEARING
TREATMENT

2

Figure
Figure

Principal Display Panel - 30-DAY KIT Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN+FIELDS

SPOTLESS
30-DAY REGIMEN
FOR TEEN ACNE

FEMALE FOUNDED + DERMATOLOGIST DEVELOPED

95%
HAD LESS
ACNE IN
5 DAYS**

DAILY ACNE WASH
BENZOYL PEROXIDE
CREAM WASH
65 ML / 2.2 FL. OZ.

ACNE CLEARING
TREATMENT
BENZOYL PEROXIDE
CREAM LOTION***

2 x 10 ML / 2 x 0.33 FL. OZ.

Figure
Figure

Principal Display Panel - 65 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN+FIELDS
SPOTLESS

DAILY
ACNE
WASH
1

Benzoyl Peroxide Cream Wash

Figure
Figure

Principal Display Panel - 20 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN+FIELDS
SPOTLESS

ACNE
CLEARING
TREATMENT
2

Benzoyl Peroxide Lotion

Figure
Figure

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
200009benzoyl peroxide 2.5 % Topical LotionPSN7
308696benzoyl peroxide 5 % Medicated Liquid SoapPSN7
200009benzoyl peroxide 25 MG/ML Topical LotionSCD7
308696benzoyl peroxide 50 MG/ML Medicated Liquid SoapSCD7
200009benzoyl peroxide 2.5 % Topical LotionSY7
308696benzoyl peroxide 5 % Medicated Liquid SoapSY7

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
14222-1600-1SPOTLESS REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS1 in 1 CARTONKIT17
14222-1610-2SPOTLESS REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS125 mL in 1 TUBECREAM125 mL0.05 g in 1mL7
14222-1620-2SPOTLESS REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTS50 mL in 1 BOTTLE, PUMPLOTION50 mL0.025 g in 1mL7
14222-1602-1SPOTLESS 30-Day Regimen1 in 1 CARTONKIT17
14222-1610-3SPOTLESS 30-Day Regimen65 mL in 1 TUBECREAM65 mL0.05 g in 1mL7
14222-1620-3SPOTLESS 30-Day Regimen20 mL in 1 BOTTLE, PUMPLOTION20 mL0.025 g in 1mL7

Products#

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

DailyMed product names page 1 of 2 · 67 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14222-160014222-1600-1
14222-161014222-1610-2, 14222-1610-3
14222-162014222-1620-2, 14222-1620-3
14222-160214222-1602-1

Ingredients#

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

DailyMed ingredient rows page 1 of 4 · 142 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB
WATER059QF0KO0RIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
DOCUSATE SODIUMF05Q2T2JA0IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HYDROGENATED JOJOBA OIL, RANDOMIZEDQ47ST02F58IACT
LAURETH-7Z95S6G8201IACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPANEDIOL5965N8W85TIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM HYDROXIDE55X04QC32IIACT
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

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPOTLESS Daily Acne WashBENZOYL PEROXIDERodan & Fields8f7bb793-3c60-4014-954e-514ef87a44fb2026-02-04WarningsExact identifier
ndc (product): 14222-1610
SPOTLESS Acne Clearing TreatmentBENZOYL PEROXIDERodan & Fields3d4ef4ce-9be3-436a-9f93-c01caa93d1a82026-02-04WarningsExact identifier
ndc (product): 14222-1620
SPOTLESS REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTSBENZOYL PEROXIDERodan & Fields8b2c187d-4b66-4872-8243-4365ea2e8b592026-02-04WarningsExact identifier
ndc (package): 14222-1620-2
ndc (package): 14222-1602-1
ndc (package): 14222-1600-1
ndc (package): 14222-1610-3
ndc (package): 14222-1620-3
ndc (package): 14222-1610-2
ndc (product): 14222-1600
ndc (product): 14222-1602
ndc11 (package): 14222162002
ndc11 (package): 14222161002
ndc11 (package): 14222161003
ndc11 (package): 14222160201
ndc11 (package): 14222160001
ndc11 (package): 14222162003
spl id: d94caf04-c19a-40f0-843e-332db06b68a5
spl set id: 8b2c187d-4b66-4872-8243-4365ea2e8b59

Reported adverse events (FAERS/openFDA)#

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