Label: RVR90 HYDRATING- zinc oxide kit
- NDC Code(s): 73122-063-01, 73122-064-01
- 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 January 10, 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 HYDRATING
zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73122-063 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73122-063-01 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 12/20/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 99.9 mL Part 2 1 BOTTLE 149.9 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:73122-064 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) 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) ISODODECANE (UNII: A8289P68Y2) TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO) PHENYLPROPANOL (UNII: 0F897O3O4M) WATER (UNII: 059QF0KO0R) CAFFEINE (UNII: 3G6A5W338E) LEVOMENOL (UNII: 24WE03BX2T) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73122-064-01 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 BRIGHTENING FOAMING CLEANSER
cleansing (cold creams, cleansing lotions, liquids, and pads) lotionProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR COCONUT OIL (UNII: Q9L0O73W7L) INGR CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR LINOLENIC ACID (UNII: 0RBV727H71) INGR .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR GLYCOL STEARATE (UNII: 0324G66D0E) INGR LAURIC ACID (UNII: 1160N9NU9U) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR SODIUM LACTATE (UNII: TU7HW0W0QT) INGR NIACINAMIDE (UNII: 25X51I8RD4) INGR LIME OIL, COLD PRESSED (UNII: UZH29XGA8G) INGR LEMON OIL, COLD PRESSED (UNII: I9GRO824LL) INGR LAVENDER OIL (UNII: ZBP1YXW0H8) INGR WATER (UNII: 059QF0KO0R) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) INGR SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR COCONUT ACID (UNII: 40U37V505D) INGR PANTHENOL (UNII: WV9CM0O67Z) INGR LINOLEIC ACID (UNII: 9KJL21T0QJ) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INGR PROPANEDIOL (UNII: 5965N8W85T) INGR EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) INGR BERGAMOT OIL (UNII: 39W1PKE3JI) INGR GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR CUCUMBER (UNII: YY7C30VXJT) INGR GERANIOL (UNII: L837108USY) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 149.9 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 12/20/2021 Part 3 of 4 ULTRA B2 HYDRATING SERUM
body and hand (excluding shaving preparations) creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR UREA (UNII: 8W8T17847W) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INGR NIACINAMIDE (UNII: 25X51I8RD4) INGR PANTHENOL (UNII: WV9CM0O67Z) INGR SORBIC ACID (UNII: X045WJ989B) INGR SALICYLIC ACID (UNII: O414PZ4LPZ) INGR CUCUMBER (UNII: YY7C30VXJT) INGR TREHALOSE (UNII: B8WCK70T7I) INGR PROPANEDIOL (UNII: 5965N8W85T) INGR WATER (UNII: 059QF0KO0R) INGR BENZYL ALCOHOL (UNII: LKG8494WBH) 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 12/20/2021 Part 4 of 4 ULTRA MOISTURISER CREAM
lotions, oils, powders, and creams creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR PHENYLPROPANOL (UNII: 0F897O3O4M) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR METHYLPROPANEDIOL (UNII: N8F53B3R4R) INGR STEARETH-20 (UNII: L0Q8IK9E08) INGR SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) INGR EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR PEG-75 STEARATE (UNII: OT38R0N74H) INGR COCONUT OIL (UNII: Q9L0O73W7L) INGR VANILLIN (UNII: CHI530446X) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR LINOLEIC ACID (UNII: 9KJL21T0QJ) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR GLYCERYL MONOBEHENATE (UNII: A626UU0W2A) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR LINOLENIC ACID (UNII: 0RBV727H71) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR CETETH-20 (UNII: I835H2IHHX) INGR POLYSORBATE 60 (UNII: CAL22UVI4M) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR UREA (UNII: 8W8T17847W) INGR CHOLESTEROL (UNII: 97C5T2UQ7J) INGR CERAMIDE NP (UNII: 4370DF050B) INGR LACTIC ACID (UNII: 33X04XA5AT) INGR ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) INGR WATER (UNII: 059QF0KO0R) INGR CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) INGR SODIUM LACTATE (UNII: TU7HW0W0QT) 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 12/20/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/20/2021 Labeler - Ultraceuticals US, LLC (117022448)
