Label: SUNDAY RILEY SULFUR ACNE TREATMENT MASK- sulfur cream

  • NDC Code(s): 73001-340-60
  • Packager: Sunday Riley Modern Skincare, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 4, 2021

If you are a consumer or patient please visit this version.

  • 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

    image description

  • INGREDIENTS AND APPEARANCE
    SUNDAY RILEY SULFUR ACNE TREATMENT MASK 
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73001-340
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR0.1 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73001-340-601 in 1 BOX01/08/2017
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/08/2017
    Labeler - Sunday Riley Modern Skincare, LLC (012302640)