Label: RVR90 FIRM- zinc oxide kit
- NDC Code(s): 73122-065-01, 73122-066-01
- 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 February 22, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
- Apply generously 15 minutes before sun exposure and Reapply at least every 2 hours.
- Children under 6 months of age: ask a doctor.
Use a water-resistant sunscreen if swimming or sweating
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. – 2 p.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 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
-
INGREDIENTS AND APPEARANCE
RVR90 FIRM
zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73122-065 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73122-065-01 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 BOTTLE 99.9 mL Part 2 1 BOTTLE 199 mL Part 3 1 BOTTLE 29.9 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:73122-066 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 ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) CARNOSINE (UNII: 8HO6PVN24W) ISODODECANE (UNII: A8289P68Y2) SODIUM HYDROXIDE (UNII: 55X04QC32I) LEVOMENOL (UNII: 24WE03BX2T) SODIUM CHLORIDE (UNII: 451W47IQ8X) PROPANEDIOL (UNII: 5965N8W85T) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) DIMETHICONE (UNII: 92RU3N3Y1O) NIACINAMIDE (UNII: 25X51I8RD4) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) METHYLPROPANEDIOL (UNII: N8F53B3R4R) ALLANTOIN (UNII: 344S277G0Z) POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO) PHENYLPROPANOL (UNII: 0F897O3O4M) WATER (UNII: 059QF0KO0R) CAFFEINE (UNII: 3G6A5W338E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73122-066-01 99.9 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 OTC monograph final part352 12/20/2021 Part 2 of 4 ULTRA BALANCING GEL CLEANSER
cleansing (cold creams, cleansing lotions, liquids, and pads) gelProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR DECYL GLUCOSIDE (UNII: Z17H97EA6Y) INGR HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) INGR GLYCOL DISTEARATE (UNII: 13W7MDN21W) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR WATER (UNII: 059QF0KO0R) INGR CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44) INGR SALICYLIC ACID (UNII: O414PZ4LPZ) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR BENZYL ALCOHOL (UNII: LKG8494WBH) INGR FORMIC ACID (UNII: 0YIW783RG1) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR PANTHENOL (UNII: WV9CM0O67Z) INGR CUCUMBER (UNII: YY7C30VXJT) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) INGR OATMEAL (UNII: 8PI54V663Y) INGR PROPANEDIOL (UNII: 5965N8W85T) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR LAURETH-4 (UNII: 6HQ855798J) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR SORBIC ACID (UNII: X045WJ989B) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 199.9 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 Part 3 of 4 ULTRA C FIRMING SERUM
body and hand (excluding shaving preparations) lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR ASCORBIC ACID (UNII: PQ6CK8PD0R) INGR CITRAL (UNII: T7EU0O9VPP) INGR SODIUM LACTATE (UNII: TU7HW0W0QT) INGR SODIUM METABISULFITE (UNII: 4VON5FNS3C) INGR PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C) INGR LACTIC ACID (UNII: 33X04XA5AT) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR LAVENDER OIL (UNII: ZBP1YXW0H8) INGR YLANG-YLANG OIL (UNII: 8YOY78GNNX) INGR CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR DEXTRAN 1 (UNII: I8LHQ0D645) INGR PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR GERANIOL (UNII: L837108USY) INGR .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) INGR DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) INGR ANOGEISSUS LEIOCARPUS BARK (UNII: U5TP1X38RH) INGR SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) INGR CAPROOYL TETRAPEPTIDE-3 (UNII: LZI0HJ3K2R) INGR ALCOHOL (UNII: 3K9958V90M) INGR SODIUM PHOSPHATE (UNII: SE337SVY37) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) INGR WATER (UNII: 059QF0KO0R) INGR PROPANEDIOL (UNII: 5965N8W85T) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) INGR POLYSORBATE 60 (UNII: CAL22UVI4M) INGR CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) INGR MENYANTHES TRIFOLIATA LEAF (UNII: GYG64DIH9P) INGR POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) INGR SODIUM SULFITE (UNII: VTK01UQK3G) INGR MANDARIN OIL (UNII: NJO720F72R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 29.9 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 Part 4 of 4 ULTRA HYDRATING LOTION
lotions, oils, powders, and creams lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR DECYL OLEATE (UNII: ZGR06DO97T) INGR SODIUM LACTATE (UNII: TU7HW0W0QT) INGR LINOLENIC ACID (UNII: 0RBV727H71) INGR SOYBEAN OIL (UNII: 241ATL177A) INGR TERT-BUTYL ALCOHOL (UNII: MD83SFE959) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR LACTIC ACID (UNII: 33X04XA5AT) INGR OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X) INGR SQUALENE (UNII: 7QWM220FJH) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) INGR AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR UREA (UNII: 8W8T17847W) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR CETEARETH-12 (UNII: 7V4MR24V5P) INGR SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) INGR CHOLESTEROL (UNII: 97C5T2UQ7J) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR PHENYLPROPANOL (UNII: 0F897O3O4M) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) INGR CETYL PALMITATE (UNII: 5ZA2S6B08X) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR BENZOIC ACID (UNII: 8SKN0B0MIM) INGR CETEARYL ISONONANOATE (UNII: P5O01U99NI) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR CERAMIDE NP (UNII: 4370DF050B) INGR METHYLPROPANEDIOL (UNII: N8F53B3R4R) INGR DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) INGR WATER (UNII: 059QF0KO0R) INGR POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) INGR LINOLEIC ACID (UNII: 9KJL21T0QJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 75.1 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 Cosmetic 12/20/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/03/2022 Labeler - Ultraceuticals US, LLC (117022448)
