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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ultra UV mineral Defense SPF 50
- Active ingredient- Ultra Clear Foaming Cleanser
- Active ingredients- Ultra Clear Treatment Lotion
- PURPOSE
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- Indications - Ultra Clear Foaming Cleanser
- Warnings- Ultra Clear Foaming Cleanser
- WARNINGS
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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.
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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
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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.
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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.
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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
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INGREDIENTS AND APPEARANCE
RVR90 CLEAR
zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73122-071 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73122-071-01 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 01/03/2022 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 99.9 mL Part 2 1 BOTTLE 149.9 mL Part 3 1 TUBE 49.9 mL Part 4 1 BOTTLE 75.1 mL Part 1 of 4 ULTRA UV PROTECTIVE MINERAL DEFENCE SPF 50
zinc oxide creamProduct Information Item Code (Source) NDC:73122-072 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 12 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:73122-072-01 99.9 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 M020 01/03/2022 Part 2 of 4 ULTRA CLEAR FOAMING CLEANSER
salicylic acid creamProduct Information Item Code (Source) NDC:73122-073 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.5 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:73122-073-01 149.9 mL in 1 BOTTLE; 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 01/03/2022 Part 3 of 4 ULTRA CLEAR TREATMENT
salicylic acid lotionProduct Information Item Code (Source) NDC:73122-074 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:73122-074-01 49.9 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 01/03/2022 Part 4 of 4 UITRA HYDRATING LOTION
lotions, oils, powders, and creams lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR GLYCERIN (UNII: PDC6A3C0OX) INGR UREA (UNII: 8W8T17847W) INGR POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR LINOLEIC ACID (UNII: 9KJL21T0QJ) INGR DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) INGR DECYL OLEATE (UNII: ZGR06DO97T) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR CHOLESTEROL (UNII: 97C5T2UQ7J) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR SOYBEAN OIL (UNII: 241ATL177A) INGR AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) INGR LACTIC ACID (UNII: 33X04XA5AT) INGR SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) INGR TERT-BUTYL ALCOHOL (UNII: MD83SFE959) INGR CETEARYL ISONONANOATE (UNII: P5O01U99NI) INGR SQUALENE (UNII: 7QWM220FJH) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR CETYL PALMITATE (UNII: 5ZA2S6B08X) INGR CERAMIDE NP (UNII: 4370DF050B) INGR CETEARETH-12 (UNII: 7V4MR24V5P) INGR AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) INGR WATER (UNII: 059QF0KO0R) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR PHENYLPROPANOL (UNII: 0F897O3O4M) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR METHYLPROPANEDIOL (UNII: N8F53B3R4R) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR BENZOIC ACID (UNII: 8SKN0B0MIM) INGR XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 75.1 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/03/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 01/03/2022 Labeler - Ultraceuticals US, LLC (117022448)