Label: RVR90 BRIGHTEN- zinc oxide kit
- NDC Code(s): 73122-061-01, 73122-062-01
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
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 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 BRIGHTEN
zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73122-061 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73122-061-01 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 11/15/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 99.9 mL Part 2 1 BOTTLE 147.9 mL Part 3 1 BOTTLE 29.8 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:73122-062 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:73122-062-01 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 part352 11/15/2021 Part 2 of 4 ULTRA BRIGHTENING FOAMING CLEANSER
cleansing (cold creams, cleansing lotions, liquids, and pads) creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR LINOLEIC ACID (UNII: 9KJL21T0QJ) INGR GERANIOL (UNII: L837108USY) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) INGR EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) INGR .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) INGR WATER (UNII: 059QF0KO0R) INGR SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM) INGR GLYCOL STEARATE (UNII: 0324G66D0E) INGR SODIUM LACTATE (UNII: TU7HW0W0QT) INGR PROPANEDIOL (UNII: 5965N8W85T) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR PANTHENOL (UNII: WV9CM0O67Z) INGR NIACINAMIDE (UNII: 25X51I8RD4) INGR COCONUT OIL (UNII: Q9L0O73W7L) INGR SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR COCONUT ACID (UNII: 40U37V505D) INGR BERGAMOT OIL (UNII: 39W1PKE3JI) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR LAURIC ACID (UNII: 1160N9NU9U) INGR LEMON OIL, COLD PRESSED (UNII: I9GRO824LL) INGR GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG) INGR LAVENDER OIL (UNII: ZBP1YXW0H8) INGR CUCUMBER (UNII: YY7C30VXJT) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR TOCOPHEROL (UNII: R0ZB2556P8) 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 11/15/2021 Part 3 of 4 ULTRA BRIGHTENING SERUM
body and hand (excluding shaving preparations) creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR LACTIC ACID (UNII: 33X04XA5AT) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR NIACINAMIDE (UNII: 25X51I8RD4) INGR SALICYLIC ACID (UNII: O414PZ4LPZ) INGR HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) INGR SODIUM SULFITE (UNII: VTK01UQK3G) INGR SODIUM PHOSPHATE (UNII: SE337SVY37) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR ALCOHOL (UNII: 3K9958V90M) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR SODIUM METABISULFITE (UNII: 4VON5FNS3C) INGR CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR MELISSA OFFICINALIS FLOWERING TOP (UNII: 5JQG17B06J) INGR BELLIS PERENNIS WHOLE (UNII: 2HU33I03UY) INGR HYDROXYRESVERATROL (UNII: 6V071CP5CR) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) INGR POLYSORBATE 60 (UNII: CAL22UVI4M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 29.8 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 11/15/2021 Part 4 of 4 ULTRA BRIGHTENING MOISTURISER CREAM
lotions, oils, powders, and creams creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR STEARETH-20 (UNII: L0Q8IK9E08) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR WATER (UNII: 059QF0KO0R) INGR NIACINAMIDE (UNII: 25X51I8RD4) INGR LAVENDER OIL (UNII: ZBP1YXW0H8) INGR SANTALUM SPICATUM OIL (UNII: H9LVS6REV4) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR RUMEX OCCIDENTALIS WHOLE (UNII: XS2Y2E2M0T) INGR OCTADECENEDIOIC ACID (UNII: 565ZMT5QRG) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR CETETH-20 (UNII: I835H2IHHX) INGR POLYSORBATE 60 (UNII: CAL22UVI4M) INGR EUCALYPTUS RADIATA LEAF OIL (UNII: SB9A7612BD) INGR CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) INGR GLYCERYL MONOBEHENATE (UNII: A626UU0W2A) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) INGR PEG-75 STEARATE (UNII: OT38R0N74H) INGR DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) INGR ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B) INGR BERGAMOT OIL (UNII: 39W1PKE3JI) INGR EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) INGR POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) INGR YLANG-YLANG OIL (UNII: 8YOY78GNNX) INGR PHENYLPROPANOL (UNII: 0F897O3O4M) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR LINOLEIC ACID (UNII: 9KJL21T0QJ) INGR SQUALANE (UNII: GW89575KF9) INGR METHYLPROPANEDIOL (UNII: N8F53B3R4R) 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 11/18/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/15/2021 Labeler - Ultraceuticals US, LLC (117022448)
