FDA.reportPublic FDA data

Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment Mask

Manufacturer
Cosco International, Inc.
Effective date
2026-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:50:08

Label at a glance#

ProductSofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment Mask
Active ingredientBenzoyl Peroxide
Label structure8 sections

Dosage and administration

Clean the skin throughly before applying this product Apply to hands, add and massage gently onto the face. Allow to dry. Rinse thoroughly. Use 1 to 2 times daily or as directed by a doctor. If dryness of 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 consult a doctor.

Label contents#

Full prescribing information#

Active Ingredient/Purpose

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide............Acne Treatment

Use

OTC - PURPOSE SECTION

For the treatment of acne

Warnings

WARNINGS SECTION

For external use only

Do not use if you

OTC - DO NOT USE SECTION

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Ask doctor before use

OTC - ASK DOCTOR SECTION

if you have redness over the affected area

When using this product

INDICATIONS & USAGE SECTION

  • 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
  • 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.
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

  • Clean the skin throughly before applying this product
  • Apply to hands, add and massage gently onto the face. Allow to dry. Rinse thoroughly.
  • Use 1 to 2 times daily or as directed by a doctor.
  • If dryness of 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 consult a doctor.

Other Information

SPL UNCLASSIFIED SECTION

Store at room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Kaolin, Bentonite, Propanediol, Sodium Hyaluronate, Methyl Gluceth-20, Phenoxyethanol, Ethylhexylglycerin, Glycolic Acid, Niacinamide, Panthenol, Hydroxyethylcellulose, Xanthan Gum, Retinyl Palmitate, Tocopheryl Acetate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60ml label60ml label60ml label60ml label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60ml carton60ml carton60ml carton60ml carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308696benzoyl peroxide 5 % Medicated Liquid SoapPSN2
308696benzoyl peroxide 50 MG/ML Medicated Liquid SoapSCD2
308696benzoyl peroxide 5 % Medicated Liquid SoapSY2

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
52261-7300-1Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment Mask0.0618 kg in 1 TUBEPASTE0.06182
52261-7300-1Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment Mask1 in 1 CARTONPASTE12

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52261-730052261-7300-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzoyl PeroxideW9WZN9A0GMACTIB
WATER059QF0KO0RIACT
KAOLIN24H4NWX5COIACT
BENTONITEA3N5ZCN45CIACT
PROPANEDIOL5965N8W85TIACT
HYALURONATE SODIUMYSE9PPT4THIACT
METHYL GLUCETH-20J3QD0LD11PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCOLIC ACID0WT12SX38SIACT
NIACINAMIDE25X51I8RD4IACT
PANTHENOLWV9CM0O67ZIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
XANTHAN GUMTTV12P4NEEIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment MaskBENZOYL PEROXIDECosco International, Inc.6d7fd1ce-2155-4aa4-87c6-c6fc0c0d3f422026-01-01WarningsExact identifier
ndc (package): 52261-7300-1
ndc (product): 52261-7300
ndc11 (package): 52261730001
spl id: b0732f47-0633-4c79-a295-b0b84192fa0d
spl set id: 6d7fd1ce-2155-4aa4-87c6-c6fc0c0d3f42

Reported adverse events (FAERS/openFDA)#

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