Acne Tinted Spot Treatment

Manufacturer
Glytone, LLC
Effective date
2025-06-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:07:01

Label at a glance#

ProductAcne Tinted Spot Treatment
Active ingredient4,6-BIS(1-METHYLPENTYL)RESORCINOL, SULFUR
Label structure12 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

For the treatment of acne.
Dries and helps clear up acne pimples and blackheads.
Helps prevent new acne blemishes from forming

WARNINGS AND PRECAUTIONS SECTION

For external use only

Do not use
• on broken skin
• on large areas of the body

When using this product
• avoid contact with eyes. If contact occurs, rinse thoroughly with water
• apply only to areas with acne
• skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only one topical acne medication at a time

Stop use and ask a doctor if
• skin irritation becomes severe

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Clean the skin thoroughly before applying this product
Cover the entire affected area with a thin layer 1 to 3 times daily
Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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

INACTIVE INGREDIENT SECTION

Water, Cyclopentasiloxane, Isocetyl Stearate, Polysorbate 60, Sorbitan Stearate, Steareth-2, PEG-100 Stearate, Steareth-21, Glycerin, Glyceryl Stearate, Butylene Glycol, Cetearyl Alcohol, Bentonite, Dimethicone Crosspolymer, Diazolidinyl Urea, Sodium Hydroxide, Methylparaben, Propylparaben, Fragrance (Parfum), Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891)

OTC - ACTIVE INGREDIENT SECTION

Sulfur 8% – Acne treatment
Resorcinol 2% – Acne treatment

WARNINGS SECTION

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

OTHER SAFETY INFORMATION

• Store at room temperature
• Avoid excessive heat and direct sunlight

DOSAGE & ADMINISTRATION SECTION

• Clean the skin thoroughly before applying this product
• Cover the entire affected area with a thin layer 1 to 3 times daily
• Because excessive drying may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day

RECENT MAJOR CHANGES SECTION

Updated section type

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.

OTC - PURPOSE SECTION

Purpose
Acne treatment

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tube labeltube labelcarton labelcarton label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84262-028-01Acne Tinted Spot Treatment30 g in 1 TUBECREAM301
84262-028-02Acne Tinted Spot Treatment30 in 1 CARTONCREAM301

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84262-02884262-028-01, 84262-028-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

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
386ed0e2-566c-9166-e063-6394a90a4f2d386ed0e2-566b-9166-e063-6394a90a4f2d2025-06-25WarningsExact identifier
spl id: 386ed0e2-566c-9166-e063-6394a90a4f2d
spl set id: 386ed0e2-566b-9166-e063-6394a90a4f2d

Reported adverse events (FAERS/openFDA)#

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