ACNE TINTED SPOT TREATMENT cream

Acne Tinted Spot Treatment by

Drug Labeling and Warnings

Acne Tinted Spot Treatment by is a Otc medication manufactured, distributed, or labeled by Glytone, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

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

WARNINGS AND PRECAUTIONS

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

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

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)

ACTIVE INGREDIENT

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

WARNINGS

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

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

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

Purpose
Acne treatment

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACNE TINTED SPOT TREATMENT 
acne tinted spot treatment cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84262-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
4,6-BIS(1-METHYLPENTYL)RESORCINOL (UNII: 0GEI7362XR) (4,6-BIS(1-METHYLPENTYL)RESORCINOL - UNII:0GEI7362XR)	4,6-BIS(1-METHYLPENTYL)RESORCINOL	2 g  in 100 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FRAGRANCE 13576 (UNII: 5EM498GW35)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALCOHOL (UNII: 3K9958V90M)
SAFFLOWER SEED OIL POLYGLYCERYL-6 ESTERS (UNII: R2Z4507WJN)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84262-028-02	30 in 1 CARTON	07/01/2025
1	NDC: 84262-028-01	30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	07/01/2025

Labeler - Glytone, LLC (119226548)