FDA.reportPublic FDA data

b pure Pressed Powder for Acne Prone Skin Tan

Manufacturer
Fourstar Group USA, Inc.
Effective date
2024-06-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:18:19

Label at a glance#

Productb pure Pressed Powder for Acne Prone Skin Tan
Active ingredientSALICYLIC ACID
Label structure8 sections

Indications and uses

For the treatment of acne.

Dosage and administration

Apply all over your face using a makeup brush, avoiding the eye area Start from the center and move to the outer portion of the face.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 0.5%

Purpose

OTC - PURPOSE SECTION

Acne medication

Uses

INDICATIONS & USAGE SECTION

For the treatment of acne.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • If using other topical acne medicines, dryness and skin irritation can occur.
  • Discontinue use if irritation occurs.
  • Do not use this product around the eye area.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply all over your face using a makeup brush, avoiding the eye area
  • Start from the center and move to the outer portion of the face.

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

mica, magnesium stearate, silica, aluminum starch octenylsuccinate, ethylhexyl palmitate, hydrogenated polyisobutene, isononyl isononanoate, tridecyl trimellitate, bis-diglyceryl polyacyladipate-2, phenoxyethanol, caprylyl glycol, ethylhexylglycerin, tocopheryl acetate, iron oxides

Questions?

OTC - QUESTIONS SECTION

1-800-639-3803

Weekdays 9 AM to 4 PM EST

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package0.jpgOuter Package0.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1241639salicylic acid 0.5 % Topical PowderPSN1
1241639salicylic acid 0.005 MG/MG Topical PowderSCD1
1241639salicylic acid 0.5 % Topical PowderSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-111-00b pure Pressed Powder for Acne Prone Skin Tan4.8 g in 1 CONTAINERPOWDER4.81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-111B PURE PRESSED POWDER FOR ACNE PRONE SKIN TAN (SALICYLIC ACID) POWDER [FOURSTAR GROUP USA, INC.]1Current NDC, 1 package rows20240901_1158f6c2-2b59-4ed3-8d28-73b6da885a5d.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80684-11180684-111-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICAV8A1AW0880IACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
ETHYLHEXYL PALMITATE2865993309IACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
TRIDECYL TRIMELLITATEFY36J270ESIACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FERRIC OXIDE RED1K09F3G675IACT
SALICYLIC ACIDO414PZ4LPZACTIB

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
b pure Pressed Powder for Acne Prone Skin TanSALICYLIC ACIDFourstar Group USA, Inc.1158f6c2-2b59-4ed3-8d28-73b6da885a5d2024-06-17WarningsExact identifier
ndc (package): 80684-111-00
ndc (product): 80684-111
ndc11 (package): 80684011100
spl id: 1b1ad176-c025-bbdb-e063-6294a90a0764
spl set id: 1158f6c2-2b59-4ed3-8d28-73b6da885a5d

Reported adverse events (FAERS/openFDA)#

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