RVR90 BRIGHTEN- zinc oxide 
Ultraceuticals US, LLC

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.

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RVR90 Brighten

Active Ingredients Purpose

Zinc Oxide 12 w/w Sunscreen

Uses

Helps prevent sunburn if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor

Warnings

Do not use:

When using this product

Directions

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:

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

Transform your skin in 90 Days

Brighten

Enhance skin's luminosity and clarity

Face Cleanser 5.07 fl. oz.

Facial Serum 1.01 fl. oz.

Facial Moisturizer 2.54 fl. oz.

sunscreen 3.38 fl. oz.

Cosmetics Bag

RVR90 brighten

RVR90 BRIGHTEN 
zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73122-061
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73122-061-011 in 1 KIT; Type 1: Convenience Kit of Co-Package11/15/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 99.9 mL
Part 21 BOTTLE 147.9 mL
Part 31 BOTTLE 29.8 mL
Part 41 BOTTLE 75.1 mL
Part 1 of 4
ULTRA UV PROTECTIVE MINERAL DEFENCE SPF 50 
zinc oxide cream
Product Information
Item Code (Source)NDC:73122-062
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73122-062-0199.9 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/15/2021
Part 2 of 4
ULTRA BRIGHTENING FOAMING CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRLINOLEIC ACID (UNII: 9KJL21T0QJ)  
INGRGERANIOL (UNII: L837108USY)  
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
INGRCAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGR.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
INGRWATER (UNII: 059QF0KO0R)  
INGRSODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)  
INGRGLYCOL STEARATE (UNII: 0324G66D0E)  
INGRSODIUM LACTATE (UNII: TU7HW0W0QT)  
INGRPROPANEDIOL (UNII: 5965N8W85T)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
INGRSODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGRCOCONUT ACID (UNII: 40U37V505D)  
INGRBERGAMOT OIL (UNII: 39W1PKE3JI)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRLAURIC ACID (UNII: 1160N9NU9U)  
INGRLEMON OIL, COLD PRESSED (UNII: I9GRO824LL)  
INGRGERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
INGRLAVENDER OIL (UNII: ZBP1YXW0H8)  
INGRCUCUMBER (UNII: YY7C30VXJT)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1149.9 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic11/15/2021
Part 3 of 4
ULTRA BRIGHTENING SERUM 
body and hand (excluding shaving preparations) cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRLACTIC ACID (UNII: 33X04XA5AT)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRSALICYLIC ACID (UNII: O414PZ4LPZ)  
INGRHYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
INGRSODIUM SULFITE (UNII: VTK01UQK3G)  
INGRSODIUM PHOSPHATE (UNII: SE337SVY37)  
INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
INGRALCOHOL (UNII: 3K9958V90M)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRSODIUM METABISULFITE (UNII: 4VON5FNS3C)  
INGRCAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRMELISSA OFFICINALIS FLOWERING TOP (UNII: 5JQG17B06J)  
INGRBELLIS PERENNIS WHOLE (UNII: 2HU33I03UY)  
INGRHYDROXYRESVERATROL (UNII: 6V071CP5CR)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRSODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
129.8 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic11/15/2021
Part 4 of 4
ULTRA BRIGHTENING MOISTURISER CREAM 
lotions, oils, powders, and creams cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRGERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRWATER (UNII: 059QF0KO0R)  
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRLAVENDER OIL (UNII: ZBP1YXW0H8)  
INGRSANTALUM SPICATUM OIL (UNII: H9LVS6REV4)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRRUMEX OCCIDENTALIS WHOLE (UNII: XS2Y2E2M0T)  
INGROCTADECENEDIOIC ACID (UNII: 565ZMT5QRG)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRCETETH-20 (UNII: I835H2IHHX)  
INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
INGREUCALYPTUS RADIATA LEAF OIL (UNII: SB9A7612BD)  
INGRCAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
INGRGLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRHYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
INGRPEG-75 STEARATE (UNII: OT38R0N74H)  
INGRDIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
INGRORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
INGRBERGAMOT OIL (UNII: 39W1PKE3JI)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRPOGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRSORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
INGRYLANG-YLANG OIL (UNII: 8YOY78GNNX)  
INGRPHENYLPROPANOL (UNII: 0F897O3O4M)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRLINOLEIC ACID (UNII: 9KJL21T0QJ)  
INGRSQUALANE (UNII: GW89575KF9)  
INGRMETHYLPROPANEDIOL (UNII: N8F53B3R4R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
175.1 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic11/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/15/2021
Labeler - Ultraceuticals US, LLC (117022448)

Revised: 1/2023
Document Id: f1ee7415-4adb-0ea6-e053-2995a90ab073
Set id: d0d6812e-dd1f-0949-e053-2995a90a036a
Version: 2
Effective Time: 20230110
 
Ultraceuticals US, LLC