Label: RVR90 CLEAR- zinc oxide kit

  • NDC Code(s): 73122-071-01, 73122-072-01, 73122-073-01, 73122-074-01
  • Packager: Ultraceuticals US, 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 September 1, 2023

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

  • Active Ultra UV mineral Defense SPF 50

    Active Ingredients Purpose

    Zinc Oxide 12 w/w Sunscreen

  • Active ingredient- Ultra Clear Foaming Cleanser

    Active ingredients Purpose

    Salicylic Acid 0.5% Acne Treatment

  • Active ingredients- Ultra Clear Treatment Lotion

    Active ingredients Purpose

    Salicylic Acid 2% w/w Acne Treatment

  • PURPOSE

    Uses

    Helps prevent sunburn if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

  • Purpose

    Uses

    • For treatment of acne
    • Clears acne blemishes
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • INDICATIONS & USAGE

    Stop use and ask a doctor

    • If skin rash occurs.
  • Indications - Ultra Clear Foaming Cleanser

    Stop use and ask a doctor:

    • if skin irritation becomes severe
  • Warnings- Ultra Clear Foaming Cleanser

    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.
  • WARNINGS

    Warnings

    Do not use:

    • on damaged or broken skin.

    When using this product

    • Keep out of eyes. Rinse with water to remove.
    • For external use only
  • Directions

    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 gradually increase to two or three times daily if needed or as directed by a doctor.
    • If dryness or peeling occurs, reduce application to once a day or every other day.
    • If going outside, apply Sunscreen after using this product. If Irritation or sensitivity develops, stop use of both product and ask a doctor.
  • DOSAGE & ADMINISTRATION

    Directions

    • Apply liberally 15 minutes before sun exposure and at least every 2 hours
    • Children under 6 months of age: ask a doctor.

    Sun Protection Measures

    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    • Limit your time in the sun, especially from 10 a.m. - 2p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses
    • reapply:
      • after 40 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours

  • Inactive Ingredients - Ultra Clear Treatment Lotion

    Inactive Ingredients:

    Water/Eau, PPG-15 Stearyl Ether, Arginine, Glycerin, Mandelic Acid, Niacinamide, Tribehenin PEG-20 Esters, Ethoxydiglycol, Methylpropanediol, Cetearyl Alcohol, Disodium Laurimodipropionate Tocopheryl Phosphates, Dimethicone, Bentonite, Caprylyl Glycol, Allantoin, Bisabolol, Hydrated Silica, Sodium PCA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate Crosspolymer-6 Xanthan Gum, Disodium EDTA, Phenylpropanol, Eucalyptus Globulus Leaf Oil, Fusanus Spicata Wood Oil, Phenoxyethanol, Eugenia Caryophyllus (Clove) Bud Oil, Aloe Barbadensis Leaf Juice Powder, Maltodextrin, T-Butyl Alcohol, Benzoic Acid, Dehydroacetic Acid.

  • Inactive ingredients- Ultra Clear Foaming Cleanser

    Inactive Ingredients

    Water/Eau, Polysorbate 20, Methylpropanediol, Decyl Glucoside, PEG-120 Methyl Glucose Dioleate, Lactic Acid, Hamamelis Virginiana Water, Cocamidopropyl Betaine, Sodium Hydroxide, Mandelic Acid, Caprylyl Glycol, Sodium Lauroyl Lactylate, Allantoin, Sodium Chloride, Sodium PCA, Disodium EDTA, Phenylpropanol, Niacinamide, Disodium Lauriminodipropionate Tocopheryl Phosphates, Eucalyptus Globulus Leaf Oil, Fusanus Spicatus Wood Oil, Eugenia Caryophyllus (Clove) Bud Oil, Sodium Benzoate, Benzoic acid, Phenoxyethanol, Dehydroacetic Acid.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Allantoin, Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caffeine, Caprylyl Glycol, Caprylyl Methicone, Carnosine, Dimethicone, Isododecane, Lauryl PEG-10 Tris (Trimethylsiloxy) Silylethyl Dimethicone, Lauryl PEG-8 Dimethicone, Methylpropanediol, Niacinamide, Octyldodecyl Neopentanoate, PEG-10, Phenylpropanol, Polymethylsilsesquioxane, Propanediol, Silica, Sodium Chloride, Sodium Hydroxide, Tetrasodium Glutamate Diacetate, Triceteareth-4 Phosphate, Tridecyl Salicylate, Water

  • PRINCIPAL DISPLAY PANEL

    Transform your skin in 90 Days

    Clear

    Visibly decongest and smooth skin while reducing future breakouts

    Acne Facial Cleanser 5.07 fl. oz.

    Acne Treatment Lotion 1.69 fl. oz.

    Facial Moisturizer 2.54 fl. oz.

    Sunscreen 3.38 fl. oz.

    Cosmetic Bag

    Belly band clear

  • INGREDIENTS AND APPEARANCE
    RVR90 CLEAR 
    zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73122-071
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73122-071-011 in 1 KIT; Type 1: Convenience Kit of Co-Package01/03/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 99.9 mL
    Part 21 BOTTLE 149.9 mL
    Part 31 TUBE 49.9 mL
    Part 41 BOTTLE 75.1 mL
    Part 1 of 4
    ULTRA UV PROTECTIVE MINERAL DEFENCE SPF 50 
    zinc oxide cream
    Product Information
    Item Code (Source)NDC:73122-072
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAFFEINE (UNII: 3G6A5W338E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73122-072-0199.9 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02001/03/2022
    Part 2 of 4
    ULTRA CLEAR FOAMING CLEANSER 
    salicylic acid cream
    Product Information
    Item Code (Source)NDC:73122-073
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    MANDELIC ACID (UNII: NH496X0UJX)  
    CLOVE OIL (UNII: 578389D6D0)  
    SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73122-073-01149.9 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/03/2022
    Part 3 of 4
    ULTRA CLEAR TREATMENT 
    salicylic acid lotion
    Product Information
    Item Code (Source)NDC:73122-074
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    WATER (UNII: 059QF0KO0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)  
    ARGININE (UNII: 94ZLA3W45F)  
    POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANDELIC ACID (UNII: NH496X0UJX)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALLANTOIN (UNII: 344S277G0Z)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CLOVE OIL (UNII: 578389D6D0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73122-074-0149.9 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/03/2022
    Part 4 of 4
    UITRA HYDRATING LOTION 
    lotions, oils, powders, and creams lotion
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRUREA (UNII: 8W8T17847W)  
    INGRPOLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    INGRTOCOPHEROL (UNII: R0ZB2556P8)  
    INGRLINOLEIC ACID (UNII: 9KJL21T0QJ)  
    INGRDICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    INGRDECYL OLEATE (UNII: ZGR06DO97T)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRCHOLESTEROL (UNII: 97C5T2UQ7J)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGROLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRSOYBEAN OIL (UNII: 241ATL177A)  
    INGRAMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    INGRLACTIC ACID (UNII: 33X04XA5AT)  
    INGRSODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    INGRTERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    INGRCETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    INGRSQUALENE (UNII: 7QWM220FJH)  
    INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGRCETYL PALMITATE (UNII: 5ZA2S6B08X)  
    INGRCERAMIDE NP (UNII: 4370DF050B)  
    INGRCETEARETH-12 (UNII: 7V4MR24V5P)  
    INGRAMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
    INGRPHENYLPROPANOL (UNII: 0F897O3O4M)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    INGRMETHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRBENZOIC ACID (UNII: 8SKN0B0MIM)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    175.1 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/03/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02001/03/2022
    Labeler - Ultraceuticals US, LLC (117022448)