Label: RVR90 RETEXTURIZE- zinc oxide kit
- NDC Code(s): 73122-069-01, 73122-070-01
- 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 23, 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 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 RETEXTURIZE
zinc oxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73122-069 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73122-069-01 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 TUBE 29.8 mL Part 4 1 TUBE 75.1 mL Part 1 of 4 ULTRA UV PROTECTIVE MINERAL DEFENCE SPF 50
zinc oxide creamProduct Information Item Code (Source) NDC:73122-070 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) PHENYLPROPANOL (UNII: 0F897O3O4M) WATER (UNII: 059QF0KO0R) CAFFEINE (UNII: 3G6A5W338E) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73122-070-01 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 01/03/2022 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 LIMONENE, (+)- (UNII: GFD7C86Q1W) 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 EDETATE DISODIUM (UNII: 7FLD91C86K) INGR ALOE VERA LEAF (UNII: ZY81Z83H0X) 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) 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 EVEN SKINTONE SMOOTHING SERUM MILD
body and hand (excluding shaving preparations) creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR ALCOHOL (UNII: 3K9958V90M) INGR LACTIC ACID (UNII: 33X04XA5AT) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INGR CUCUMBER (UNII: YY7C30VXJT) INGR HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) INGR SALIX ALBA BARK (UNII: 205MXS71H7) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR NIACINAMIDE (UNII: 25X51I8RD4) INGR CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) INGR SALICYLIC ACID (UNII: O414PZ4LPZ) INGR WATER (UNII: 059QF0KO0R) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR PROPANEDIOL (UNII: 5965N8W85T) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 29.8 mL in 1 TUBE; 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 EVEN SKINTONE SMOOTHING MOISTURISER
moisturizing creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR 3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P) INGR CETETH-20 (UNII: I835H2IHHX) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR LINOLENIC ACID (UNII: 0RBV727H71) INGR PHENYLPROPANOL (UNII: 0F897O3O4M) INGR UREA (UNII: 8W8T17847W) INGR WATER (UNII: 059QF0KO0R) INGR CERAMIDE NP (UNII: 4370DF050B) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR LINOLEIC ACID (UNII: 9KJL21T0QJ) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR GLYCERYL MONOBEHENATE (UNII: A626UU0W2A) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) INGR STEARETH-20 (UNII: L0Q8IK9E08) INGR POLYSORBATE 60 (UNII: CAL22UVI4M) INGR PEG-75 STEARATE (UNII: OT38R0N74H) INGR EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) INGR ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR METHYLPROPANEDIOL (UNII: N8F53B3R4R) INGR NIACINAMIDE (UNII: 25X51I8RD4) INGR HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 75.1 mL in 1 TUBE; 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)
