RVR90 HYDRATING- 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 Hydrating

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 on:

When using this product

For external use only

Directions

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:

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

Hydrating

Boost Skin's hydration levels for smoother, more youthful looking skin

Facial Cleanser 5.07 fl. oz.

Facial Serum 1.01 fl. oz.

Facial Moisturizer 2.54 fl. oz.

Sunscreen 3.38 fl. oz.

Cosmetics Bag

Hydrating RVR Kit

RVR90 HYDRATING 
zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73122-063
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73122-063-011 in 1 KIT; Type 1: Convenience Kit of Co-Package12/20/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 99.9 mL
Part 21 BOTTLE 149.9 mL
Part 31 BOTTLE 29.9 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:73122-064
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73122-064-0199.9 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/20/2021
Part 2 of 4
ULTRA BRIGHTENING FOAMING CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
INGRCAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRLINOLENIC ACID (UNII: 0RBV727H71)  
INGR.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGRGLYCOL STEARATE (UNII: 0324G66D0E)  
INGRLAURIC ACID (UNII: 1160N9NU9U)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRSODIUM LACTATE (UNII: TU7HW0W0QT)  
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRLIME OIL, COLD PRESSED (UNII: UZH29XGA8G)  
INGRLEMON OIL, COLD PRESSED (UNII: I9GRO824LL)  
INGRLAVENDER OIL (UNII: ZBP1YXW0H8)  
INGRWATER (UNII: 059QF0KO0R)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRSODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
INGRSODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRCOCONUT ACID (UNII: 40U37V505D)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRLINOLEIC ACID (UNII: 9KJL21T0QJ)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRPROPANEDIOL (UNII: 5965N8W85T)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRBERGAMOT OIL (UNII: 39W1PKE3JI)  
INGRGERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRCUCUMBER (UNII: YY7C30VXJT)  
INGRGERANIOL (UNII: L837108USY)  
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
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
Cosmetic12/20/2021
Part 3 of 4
ULTRA B2 HYDRATING SERUM 
body and hand (excluding shaving preparations) cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRUREA (UNII: 8W8T17847W)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRSORBIC ACID (UNII: X045WJ989B)  
INGRSALICYLIC ACID (UNII: O414PZ4LPZ)  
INGRCUCUMBER (UNII: YY7C30VXJT)  
INGRTREHALOSE (UNII: B8WCK70T7I)  
INGRPROPANEDIOL (UNII: 5965N8W85T)  
INGRWATER (UNII: 059QF0KO0R)  
INGRBENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
129.9 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic12/20/2021
Part 4 of 4
ULTRA MOISTURISER CREAM 
lotions, oils, powders, and creams cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRPHENYLPROPANOL (UNII: 0F897O3O4M)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRMETHYLPROPANEDIOL (UNII: N8F53B3R4R)  
INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
INGRSORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRPEG-75 STEARATE (UNII: OT38R0N74H)  
INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
INGRVANILLIN (UNII: CHI530446X)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRLINOLEIC ACID (UNII: 9KJL21T0QJ)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRGLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRLINOLENIC ACID (UNII: 0RBV727H71)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRCETETH-20 (UNII: I835H2IHHX)  
INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRUREA (UNII: 8W8T17847W)  
INGRCHOLESTEROL (UNII: 97C5T2UQ7J)  
INGRCERAMIDE NP (UNII: 4370DF050B)  
INGRLACTIC ACID (UNII: 33X04XA5AT)  
INGRALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRHYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
INGRWATER (UNII: 059QF0KO0R)  
INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
INGRSODIUM LACTATE (UNII: TU7HW0W0QT)  
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
Cosmetic12/20/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/20/2021
Labeler - Ultraceuticals US, LLC (117022448)

Revised: 1/2023
Document Id: f1ee79a6-d462-79a7-e053-2a95a90a327d
Set id: d397fadf-c548-d7e0-e053-2995a90aa007
Version: 2
Effective Time: 20230110
 
Ultraceuticals US, LLC