Label: ACNE ALL-STAR 3-IN-1 ACNE CLEANSER, MASK AND SPOT TREATMENT- sulfur lotion liquid

  • 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 July 24, 2022

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

  • Active Ingredients

    Sulfur 3%

  • Purpose

    Acne Treatment

  • Uses

    Treats acne. Helps prevent the development of new acne blemishes.

  • Warnings

    For external use only.

    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 one
    topical acne medication at a time.

    Do not use on
    • Broken skin
    • Large areas of the skin.

    When using this product
    • Apply only to areas with acne
    • Avoid contact with the eyes
    • If contact occurs, rinse thoroughly with water

  • 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.

  • Directions

    • Clean the skin thoroughly before applying this product.
    • Cover the entire affected area with a thin layer and rinse thoroughly one
    to three times daily.
    • Because excessive drying of the skin may occur, start with one
    application daily, then increase to two or three 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 Ingredients

    WATER (AQUA), GLYCERIN, BENTONITE, SODIUM COCOYL ISETHIONATE, PROPANEDIOL, SODIUM COCOYL GLYCINATE, 1,2-HEXANEDIOL, MAGNESIUM ALUMINUM SILICATE, ACACIA SENEGAL GUM, SEA WATER, SALIX ALBA (WILLOW) BARK EXTRACT, LACTOCOCCUS FERMENT LYSATE, LACTOBACILLUS, LACTOBACILLUS FERMENT, CAMELLIA OLEIFERA LEAF EXTRACT, BETULA ALBA BARK EXTRACT, SCROPHULARIA NODOSA EXTRACT, BETULA ALBA JUICE, PINUS DENSIFLORA LEAF EXTRACT, ASPALATHUS LINEARIS LEAF EXTRACT,
    PANTHENOL, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, BETA VULGARIS (BEET) ROOT EXTRACT, ALPHA-GLUCAN OLIGOSACCHARIDE, POLYMNIA SONCHIFOLIA ROOT JUICE, INULIN, LACTIC ACID, LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE, ANANAS SATIVUS (PINEAPPLE) FRUIT EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT, CITRUS LIMON (LEMON) PEEL EXTRACT, EUGENIA CARYPHYLLUS (CLOVE) FLOWER EXTRACT, PYRUS COMMUNIS (PEAR) FRUIT EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, SALVIA OFFICINALIS (SAGE) LEAF EXTRACT, VANILLA PLANIFOLIA FRUIT EXTRACT, SODIUM CHLORIDE, SORBITAN OLEATE DECYLGLUCOSIDE CROSSPOLYMER, MALTODEXTRIN, BUTYLENE GLYCOL, SODIUM BENZOATE, DIPROPYLENE GLYCOL, HYDROXYPROPYL CYCLODEXTRIN, POTASSIUM SORBATE, CITRIC ACID, QUARTZ, CHLOROPHYLLIN-COPPER COMPLEX, SODIUM COCOATE, COCONUT ACID, SODIUM ISETHIONATE, TITANIUM DIOXIDE (CI 77891).

  • Principal Display Panel

    72296-090-01

  • INGREDIENTS AND APPEARANCE
    ACNE ALL-STAR 3-IN-1 ACNE CLEANSER, MASK AND SPOT TREATMENT 
    sulfur lotion liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72296-090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BENTONITE (UNII: A3N5ZCN45C)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    ACACIA (UNII: 5C5403N26O)  
    COCONUT ACID (UNII: 40U37V505D)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    WILLOW BARK (UNII: S883J9JDYX)  
    SODIUM ISETHIONATE (UNII: 3R36J71C17)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PINEAPPLE JUICE (UNII: O4KOG0B1KC)  
    ORANGE JUICE (UNII: 5A9KE2L9L3)  
    LEMON PEEL (UNII: 72O054U628)  
    CLOVE (UNII: K48IKT5321)  
    PEAR JUICE (UNII: F214DLA9BE)  
    APPLE JUICE (UNII: 9871T0PD5P)  
    SALVIA OFFICINALIS FLOWERING TOP (UNII: 48JCS720FN)  
    VANILLA PLANIFOLIA SEED (UNII: GKQ4MH0F2E)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    BETA VULGARIS (UNII: 4G174V5051)  
    COPPER CHLOROPHYLLIN (UNII: EEM82VOY7C)  
    TURMERIC (UNII: 856YO1Z64F)  
    INULIN (UNII: JOS53KRJ01)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    LACTOBACILLUS ACIDOPHILUS (UNII: 1PRR1V42V5)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    SCROPHULARIA NODOSA (UNII: 7H443NUB2T)  
    ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
    HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN (UNII: ZFR0T80O4Y)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    PINUS DENSIFLORA LEAF (UNII: Q1Q9P50WIY)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72296-090-011 in 1 CARTON07/25/2022
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/25/2022
    Labeler - Tula Life LLC (080051358)
    Registrant - Tula Life LLC (080051358)
    Establishment
    NameAddressID/FEIBusiness Operations
    Innovation Labs, Inc.117109069manufacture(72296-090)