SUNDAY RILEY SULFUR ACNE TREATMENT MASK- sulfur cream

SUNDAY RILEY SULFUR ACNE TREATMENT MASK by

Drug Labeling and Warnings

SUNDAY RILEY SULFUR ACNE TREATMENT MASK by is a Otc medication manufactured, distributed, or labeled by Sunday Riley Modern Skincare, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug facts

Active Ingredients

Sulfur 10%

Purpose

Acne treatment

Uses

• For the management of acne
• Penetrates pores to control blackheads
• Helps prevent new acne blemishes and blackheads from forming

Warnings

For external use only.

When using this product

• Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin
• if this occurs, only one medication should be used
• Apply only to areas with acne

Do not use on

• Broken skin
• Large areas of the skin

Keep out of reach of children.

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

Directions

• Cleanse the skin thoroughly before applying medication.
• For rinse off treatment, apply to dry skin.
• Leave on for 20 minutes and rinse off thoroughly with water.
• For leave-on, overnight treatment, apply to affected area, and rinse off thoroughly in the morning with water.
• Use 2-3 times a week.
• If going outside, use a sunscreen.
• If bothersome dryness or peeling occurs, reduce application use.

Inactive Ingredients

Aqua/Water, Bentonite, Niacinamide, Isoamyl Laurate, Cetyl Ethyhexanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Olive Oil Glycereth-8 Esters, Polyglyceryl-2 Caprate, Gum Arabic, Sorbitan Isostearate, Polysorbate 60, Zinc PCA, Leptospermum Scoparium (Manuca) Brach/Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Dipotassium Glycyrrhizate, Allantoin, Quartz, Plosorbate 20, PEG-40 Hydrogenated Castor Oil, Disodium EDTA, Tocopherol, Alcohol Denat., Melia Azadirachta Leaf Extract, Amber Powder, Melia Azadirachta Flower Extract, Coccinia Indica Fruit Extract, Ocimum Basilicum Flower/Leaf Extract, Solanum Melongena Leaf Extract, Curcuma Longa Root Extract, Corallina Officinalis Extract, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin

SPL UNCLASSIFIED SECTION

for acne-prone skin

10% Sulfur + 4% Niacinamide + 1% Zinc

SATURN

Medicated mask dries and clears up acne, while preventing new blemishes from forming

10% sulfur penetrates pores to clear up existing acne while preventing new blemishes from forming. Treats multiple forms of acne breakouts, including blocked pores, inflammatory acne, hormonal acne and acne rosacea.

4% niacinamide promotes clear skin, while boosting skin's healthy-looking radiance. Zinc PCA and bentonite help to clear impurities, reduce excess oil, and soothe the appearance of redness, without overdrying.

Highly potent tea tree oil, standardized for high levels of terpinen-4-ol, partnered with manuka oil, purifies the skin, Complexion looks and feels smoother and clearer with each use.

Made in USA of responsibly sourced domestic and foreign ingredients

Dist: Sunday Riley Modern Skincare, LLC

Houston, TX 77027

EU RP: Obelis s.a., 1030 Brussels, Belgium

www.sundayriley.com

Packaging

INGREDIENTS AND APPEARANCE

SUNDAY RILEY SULFUR ACNE TREATMENT MASK 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73001-340
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	6 g  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BENTONITE (UNII: A3N5ZCN45C)
NIACINAMIDE (UNII: 25X51I8RD4)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
OLIVE OIL GLYCERETH-8 ESTERS (UNII: 322K2STO13)
POLYGLYCERYL-2 CAPRATE (UNII: JX7WXJ41DH)
ACACIA (UNII: 5C5403N26O)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ZINC PIDOLATE (UNII: C32PQ86DH4)
MANUKA OIL (UNII: M6QU9ZUH2X)
4-TERPINEOL, (+/-)- (UNII: L65MV77ZG6)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ALLANTOIN (UNII: 344S277G0Z)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
TOCOPHEROL (UNII: R0ZB2556P8)
ALCOHOL (UNII: 3K9958V90M)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
AMBER (UNII: 70J9Z0J26P)
AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)
COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)
OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2)
EGGPLANT (UNII: W5K7RAS4VK)
TURMERIC (UNII: 856YO1Z64F)
CORALLINA OFFICINALIS (UNII: 4004498D06)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73001-340-60	1 in 1 BOX	01/08/2017
1		60 mL 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 final	part333D	01/08/2017

Labeler - Sunday Riley Modern Skincare, Llc (012302640)