drug facts

drug facts

SPL v4

SPL

SPL Set ID c9fc0bd0-116d-4af6-97e7-2ba2d687821c

Route

topical

Published

Effective Date 2019-05-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

sulfur (0.1 g)

Inactive Ingredients

water kaolin glycerin pentylene glycol titanium dioxide magnesium aluminum silicate microcrystalline cellulose butylene glycol naringenin tea tree oil oat bran hydroxyphenyl propamidobenzoic acid mannitol panthenol triacetate, (+)- hypromellose, unspecified xanthan gum medium-chain triglycerides polysorbate 20 sodium alginate 1,2-hexanediol ascorbyl palmitate hydroxyacetophenone caprylyl glycol phenoxyethanol aluminum hydroxide barium sulfate silicon dioxide ferrosoferric oxide d&c red no. 30 ultramarine blue limonene, (+)- linalool, (+/-)- .beta.-citronellol, (r)- geraniol

Identifiers & Packaging

Marketing Status

otc monograph drug completed Since 2019-05-15 Until 2026-03-26

Purpose

Acne treatment

Description

Sulfur 10%

Medication Information

Warnings

For external use only

Uses

For the treatment of acne.
Helps keep skin clear of new acne blemishes, acne pimples, blackheads, and whiteheads.

Purpose

Acne treatment

Directions

Massage onto clean dry skin; leave on for 5-10 minutes. Rinse thoroughly.
Because excessive drying of the skin may occur, start with one application weekly.
If bothersome dryness or peeling occurs, reduce application frequency.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Kaolin, Glycerin, Pentylene Glycol, Titanium Dioxide (CI 77891), Magnesium Aluminum Silicate, Microcrystalline Cellulose, Butylene Glycol, Naringenin, Phaeodactylum Tricornutum Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Avena Sativa (Oat) Bran Extract, Hydroxyphenyl Propamidobenzoic Acid, Simethicone, Mannitol, Panthenyl Triacetate, Sodium Acryloyldimethyltaurate/VP Crosspolymer, Acrylates Copolymer, Hydroxypropyl Methylcellulose, Xanthan Gum, Caprylic/Capric Glycerides, Polysorbate 20, Algin, 1,2-Hexanediol, Ascorbyl Palmitate, Hydroxyacetophenone, Caprylyl Glycol, Phenoxyethanol, Aluminum Hydroxide, Barium Sulfate, Silica, Iron Oxides (CI 77499), Red 30 (CI 73360), Ultramarines (CI 77007).

Description

Sulfur 10%

Questions

1-888-995-5656

Do Not Use On

Broken skin
Large areas of the skin.

Active Ingredients

Sulfur 10%

Stop and Ask A Doctor

if skin irritation occurs or get worse.

When Using This Product

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 on topical acne medication at a time.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Principal Display Panel Unblemish Clarifying Mask 7 Ml Jar Label

RODAN+FIELDS

UNBLEMISH

Clarifying Mask

Principal Display Panel Unblemish Clarifying Mask 50 Ml Jar Label

RODAN+FIELDS

UNBLEMISH

Clarifying Mask

Principal Display Panel Unblemish Clarifying Mask 7 Ml Carton Label

RODAN+FIELDS

UNBLEMISH

Clarifying Mask

RODAN+FIELDS

7 mL/0.23 FL Oz. U.S

Principal Display Panel Unblemish Clarifying Mask 50 Ml Carton Label

RODAN+FIELDS

UNBLEMISH

Clarifying Mask

RODAN+FIELDS

50 mL/1.69 FL Oz. U.S

Structured Label Content

Warnings

For external use only

Uses

For the treatment of acne.
Helps keep skin clear of new acne blemishes, acne pimples, blackheads, and whiteheads.

Purpose

Acne treatment

Directions

Massage onto clean dry skin; leave on for 5-10 minutes. Rinse thoroughly.
Because excessive drying of the skin may occur, start with one application weekly.
If bothersome dryness or peeling occurs, reduce application frequency.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Questions

1-888-995-5656

Do Not Use On (Do not use on)

Broken skin
Large areas of the skin.

Active Ingredients

Sulfur 10%

Stop and Ask A Doctor (Stop and ask a doctor)

if skin irritation occurs or get worse.

When Using This Product (When using this product)

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 on topical acne medication at a time.

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.

Principal Display Panel Unblemish Clarifying Mask 7 Ml Jar Label (Principal Display Panel - Unblemish Clarifying Mask 7 mL Jar Label)

RODAN+FIELDS

UNBLEMISH

Clarifying Mask

Principal Display Panel Unblemish Clarifying Mask 50 Ml Jar Label (Principal Display Panel - Unblemish Clarifying Mask 50 mL Jar Label)

RODAN+FIELDS

UNBLEMISH

Clarifying Mask

Principal Display Panel Unblemish Clarifying Mask 7 Ml Carton Label (Principal Display Panel - Unblemish Clarifying Mask 7 mL Carton Label)

RODAN+FIELDS

UNBLEMISH

Clarifying Mask

RODAN+FIELDS

7 mL/0.23 FL Oz. U.S

Principal Display Panel Unblemish Clarifying Mask 50 Ml Carton Label (Principal Display Panel - Unblemish Clarifying Mask 50 mL Carton Label)

RODAN+FIELDS

UNBLEMISH

Clarifying Mask

RODAN+FIELDS

50 mL/1.69 FL Oz. U.S

Advanced Ingredient Data

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"strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM ALUMINUM SILICATE", "unii": "6M3P64V0NC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "NARINGENIN", "unii": "HN5425SBF2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TEA TREE OIL", "unii": "VIF565UC2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OAT BRAN", "unii": "KQX236OK4U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPHENYL PROPAMIDOBENZOIC ACID", "unii": "25KRT26H77", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PANTHENOL TRIACETATE, (+)-", "unii": "1206E8961B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MEDIUM-CHAIN TRIGLYCERIDES", "unii": "C9H2L21V7U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM ALGINATE", "unii": "C269C4G2ZQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "1,2-HEXANEDIOL", "unii": "TR046Y3K1G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASCORBYL PALMITATE", "unii": "QN83US2B0N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYACETOPHENONE", "unii": "G1L3HT4CMH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRYLYL GLYCOL", "unii": "00YIU5438U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALUMINUM HYDROXIDE", "unii": "5QB0T2IUN0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BARIUM SULFATE", "unii": "25BB7EKE2E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERROSOFERRIC OXIDE", "unii": "XM0M87F357", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 30", "unii": "2S42T2808B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ULTRAMARINE BLUE", "unii": "I39WR998BI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIMONENE, (+)-", "unii": "GFD7C86Q1W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LINALOOL, (+/-)-", "unii": "D81QY6I88E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".BETA.-CITRONELLOL, (R)-", "unii": "P01OUT964K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GERANIOL", "unii": "L837108USY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the treatment of acne. Helps keep skin clear of new acne blemishes, acne pimples, blackheads, and whiteheads.", "Purpose": "Acne treatment", "Warnings": "For external use only", "Questions": "1-888-995-5656", "Directions": "Massage onto clean dry skin; leave on for 5-10 minutes. Rinse thoroughly. Because excessive drying of the skin may occur, start with one application weekly. If bothersome dryness or peeling occurs, reduce application frequency.", "Do not use on": "Broken skin Large areas of the skin.", "Other Information": "Protect this product from excessive heat and direct sun.", "Active Ingredients": "Sulfur 10%", "Inactive Ingredients": "Water, Kaolin, Glycerin, Pentylene Glycol, Titanium Dioxide (CI 77891), Magnesium Aluminum Silicate, Microcrystalline Cellulose, Butylene Glycol, Naringenin, Phaeodactylum Tricornutum Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Avena Sativa (Oat) Bran Extract, Hydroxyphenyl Propamidobenzoic Acid, Simethicone, Mannitol, Panthenyl Triacetate, Sodium Acryloyldimethyltaurate/VP Crosspolymer, Acrylates Copolymer, Hydroxypropyl Methylcellulose, Xanthan Gum, Caprylic/Capric Glycerides, Polysorbate 20, Algin, 1,2-Hexanediol, Ascorbyl Palmitate, Hydroxyacetophenone, Caprylyl Glycol, Phenoxyethanol, Aluminum Hydroxide, Barium Sulfate, Silica, Iron Oxides (CI 77499), Red 30 (CI 73360), Ultramarines (CI 77007).", "Stop and ask a doctor": "if skin irritation occurs or get worse.", "When using this product": "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 on topical acne medication at a time.", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Principal Display Panel - Unblemish Clarifying Mask 7 mL Jar Label": "RODAN+FIELDS UNBLEMISH Clarifying Mask", "Principal Display Panel - Unblemish Clarifying Mask 50 mL Jar Label": "RODAN+FIELDS UNBLEMISH Clarifying Mask", "Principal Display Panel - Unblemish Clarifying Mask 7 mL Carton Label": "RODAN+FIELDS UNBLEMISH Clarifying Mask RODAN+FIELDS 7 mL/0.23 FL Oz. U.S", "Principal Display Panel - Unblemish Clarifying Mask 50 mL Carton Label": "RODAN+FIELDS UNBLEMISH Clarifying Mask RODAN+FIELDS 50 mL/1.69 FL Oz. U.S"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:46.755969 · Updated: 2026-03-14T23:11:35.907821