FDA.reportPublic FDA data

Solimo Renewing Cleanser For Acne Prone Skin

Manufacturer
Amazon.com Services LLC | Filltech USA, LLC
Effective date
2023-11-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:21:13

Label at a glance#

ProductSolimo Renewing Cleanser For Acne Prone Skin
Active ingredientBENZOYL PEROXIDE
Label structure7 sections

Indications and uses

for the management of acne

Dosage and administration

Apply product sparinglyto one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. Sensitivity Test for a New User: apply a small amount to dampened skin. cover the entire affected area with a thin layer and rinse thoroughly one to three times daily. because excessive drying of the skin may occur, start with one application daily, then gradually increase...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 2.5%

Purpose

OTC - PURPOSE SECTION

Acne treatment gel

Uses

INDICATIONS & USAGE SECTION

  • for the management of acne

Warnings

WARNINGS SECTION

For external use only.

When using this product:

OTC - WHEN USING SECTION

  • do not use this product more than three times per day.
  • 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.
  • 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.
  • 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.

Do not use

OTC - DO NOT USE SECTION

if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation becomes severe.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply product sparinglyto one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. Sensitivity Test for a New User:
  • apply a small amount to dampened skin.
  • cover the entire affected area with a thin layer and rinse thoroughly one to three times daily.
  • 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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, cetyl esters, sorbitol, propylene glycol, polyethylene, dimethyl isosorbide, magnesium aluminum silicate, tridecyl trimellitate, glyceryl stearate, xanthan gum, peg-100 stearate, disodium peg-12 dimethicone sulfosuccinate, tridecyl stearate, neopentylglycol dicaprylate/dicaprate, sodium pca, imidazolidinyl urea, fragrance, methylparaben, propylparaben, carthamus tinctorius (safflower) seed oil, sodium hyaluronate, chamomilla recutita (matricaria) flower extract.

Package Labeling: 2oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling: 4oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72288-52672288-526-02, 72288-526-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CETYL ESTERS WAXD072FFP9GUIACT
SORBITOL506T60A25RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
TRIDECYL TRIMELLITATEFY36J270ESIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
XANTHAN GUMTTV12P4NEEIACT
PEG-100 STEARATEYD01N1999RIACT
TRIDECYL STEARATEA8OE252M6LIACT
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATEVLW429K27KIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
IMIDUREAM629807ATLIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
SAFFLOWER OIL65UEH262ISIACT
HYALURONATE SODIUMYSE9PPT4THIACT
CHAMOMILEFGL3685T2XIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

Source Document#

Source XML

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
2cd805e2-8ab6-6a3e-e063-6294a90a26a525d9b4d1-1314-497e-ae79-ba0c38f020e72025-01-29WarningsExact identifier
spl set id: 25d9b4d1-1314-497e-ae79-ba0c38f020e7

Reported adverse events (FAERS/openFDA)#

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