Bareminerals Blemish Therapy

Bareminerals Blemish Therapy
SPL v1
SPL
SPL Set ID c5b9f8cb-6e79-47d3-bbc8-9914344be13b
Route
TOPICAL
Published
Effective Date 2014-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (30 mg)
Inactive Ingredients
Zinc Stearate Barium Sulfate Silicon Dioxide Salix Alba Bark Starch, Tapioca Kaolin Melaleuca Alternifolia Leaf Betaine Salicylate Aloe Vera Leaf Tea Tree Oil Phyllanthus Emblica Fruit Sophora Flavescens Root Retinol Icodextrin Maltodextrin Farnesol Niacinamide Magnesium Myristate Mica Bismuth Oxychloride Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-12-31

Description

Drug Facts

Purpose

ACNE TREATMENT


Medication Information

Indications and Usage

USE FOR THE TREATMENT OF ACNE. CLEARS ACNE BLEMISHES AND ALLOWS SKIN TO HEAL. PENETRATES PORES TO CONTROL BLACKHEADS. HELPS PREVENT NEW ACNE BLEMISHES FROM FORMING.

Purpose

ACNE TREATMENT

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9

IF EXCESSIVE SKIN IRRITATION DEVELOPS OR INCREASES, DISCONTINUE USE AND CONSULT A DOCTOR.

Section 50570-1

DO NOT GET INTO EYES.

Warnings

FOR EXTERNAL USE ONLY.

USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

Directions

SWIRL BRUSH INTO TREATMENT, TAP OFF EXCESS AND GENTLY PAT ONTO BLEMISH. FOR LARGER PROBLEM AREAS, APPLY A LIGHT LAYER OVER AFFECTED AREA (AVOIDING THE EYE AREA). FOR BEST RESULTS, USE AT THE ONSET OF A BLEMISH. APPLYING A LIGHT LAYER OVER PROBLEM AREAS DAILY CAN ALSO HELP PREVENT NEW BREAKOUTS FROM FORMING.

Active Ingredient

SULFUR 3.0%

Inactive Ingredients

ZINC STEARATE, ILITE, BARIUM SULFATE, SILICA, SALIX ALBA (WILOW) BARK EXTRACT, TAPI OCA STARCH, SOIL MINERALS, KA OLIN, CYCL ODEXTRIN, MELALEUCA ALTERNIF OLIA (TEA TRE) LEAF EXTRACT, DIMETHICONE/ VINYL DIMETHICONE CROSSPOLYMER, BETAINE SALICYLATE, CORN STARCH MODIFIED, ALOE BARBADENSIS LEAF JUICE, MELALEUCA ALTERNIF OLIA (TEA TRE) LEAF OIL, EMBLICA OFFICINALIS FRUIT EXTRACT, SOPHORA ANGUSTIFOLIA EXTRACT, ALGAE EXTRACT, RETINOL, DEXTRIN, HYDROXYPR OPYL CYCL ODEXTRIN, MALT ODEXTRIN, FARNE SOL, NIACINAMIDE, MAGNESIUM MYRISTATE, CALCIUM SODIUM PHOSPHOSILICATE, MICA, BISMUTH OXYCHL ORIDE, TITANIUM DIOXIDE.

Adverse Event Reporting

71 STEVENSON ST. 22 FL., SF, CA 94105. ATTN: OTC

Principal Display Panel 1 G Jar Carton

bareMinerals

BLEMISH

THERAPY

1 g / 0.03 Oz.


Structured Label Content

Indications and Usage (34067-9)

USE FOR THE TREATMENT OF ACNE. CLEARS ACNE BLEMISHES AND ALLOWS SKIN TO HEAL. PENETRATES PORES TO CONTROL BLACKHEADS. HELPS PREVENT NEW ACNE BLEMISHES FROM FORMING.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9 (50566-9)

IF EXCESSIVE SKIN IRRITATION DEVELOPS OR INCREASES, DISCONTINUE USE AND CONSULT A DOCTOR.

Section 50570-1 (50570-1)

DO NOT GET INTO EYES.

Purpose (PURPOSE)

ACNE TREATMENT

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

Directions (DIRECTIONS)

SWIRL BRUSH INTO TREATMENT, TAP OFF EXCESS AND GENTLY PAT ONTO BLEMISH. FOR LARGER PROBLEM AREAS, APPLY A LIGHT LAYER OVER AFFECTED AREA (AVOIDING THE EYE AREA). FOR BEST RESULTS, USE AT THE ONSET OF A BLEMISH. APPLYING A LIGHT LAYER OVER PROBLEM AREAS DAILY CAN ALSO HELP PREVENT NEW BREAKOUTS FROM FORMING.

Active Ingredient (ACTIVE INGREDIENT)

SULFUR 3.0%

Inactive Ingredients (INACTIVE INGREDIENTS)

ZINC STEARATE, ILITE, BARIUM SULFATE, SILICA, SALIX ALBA (WILOW) BARK EXTRACT, TAPI OCA STARCH, SOIL MINERALS, KA OLIN, CYCL ODEXTRIN, MELALEUCA ALTERNIF OLIA (TEA TRE) LEAF EXTRACT, DIMETHICONE/ VINYL DIMETHICONE CROSSPOLYMER, BETAINE SALICYLATE, CORN STARCH MODIFIED, ALOE BARBADENSIS LEAF JUICE, MELALEUCA ALTERNIF OLIA (TEA TRE) LEAF OIL, EMBLICA OFFICINALIS FRUIT EXTRACT, SOPHORA ANGUSTIFOLIA EXTRACT, ALGAE EXTRACT, RETINOL, DEXTRIN, HYDROXYPR OPYL CYCL ODEXTRIN, MALT ODEXTRIN, FARNE SOL, NIACINAMIDE, MAGNESIUM MYRISTATE, CALCIUM SODIUM PHOSPHOSILICATE, MICA, BISMUTH OXYCHL ORIDE, TITANIUM DIOXIDE.

Adverse Event Reporting (ADVERSE EVENT REPORTING)

71 STEVENSON ST. 22 FL., SF, CA 94105. ATTN: OTC

Principal Display Panel 1 G Jar Carton (PRINCIPAL DISPLAY PANEL - 1 g Jar Carton)

bareMinerals

BLEMISH

THERAPY

1 g / 0.03 Oz.


Advanced Ingredient Data


Raw Label Data

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