RVR90 RETEXTURIZE- 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 Retexturize

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

Retexturize

Exfoliate, clarify and refine skin for a refreshed and energized complexion

Facial Cleanser 6.ty fl. oz.

Facial Serum 1.01 fl. oz.

Facial Moisturizer 2.54 fl. oz.

Sunscreen 3.38 fl. oz.

Cosmetics Bag

Retexturize band

RVR90 RETEXTURIZE 
zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73122-069
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73122-069-011 in 1 KIT; Type 1: Convenience Kit of Co-Package01/03/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 99.9 mL
Part 21 BOTTLE 199 mL
Part 31 TUBE 29.8 mL
Part 41 TUBE 75.1 mL
Part 1 of 4
ULTRA UV PROTECTIVE MINERAL DEFENCE SPF 50 
zinc oxide cream
Product Information
Item Code (Source)NDC:73122-070
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73122-070-0199.9 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 finalpart35201/03/2022
Part 2 of 4
ULTRA BALANCING GEL CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) gel
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
INGRDECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
INGRHYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
INGRGLYCOL DISTEARATE (UNII: 13W7MDN21W)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRWATER (UNII: 059QF0KO0R)  
INGRCITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)  
INGRSALICYLIC ACID (UNII: O414PZ4LPZ)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRBENZYL ALCOHOL (UNII: LKG8494WBH)  
INGRFORMIC ACID (UNII: 0YIW783RG1)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRCUCUMBER (UNII: YY7C30VXJT)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRSODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
INGROATMEAL (UNII: 8PI54V663Y)  
INGRPROPANEDIOL (UNII: 5965N8W85T)  
INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGRSODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRLAURETH-4 (UNII: 6HQ855798J)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRSORBIC ACID (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1199.9 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/03/2022
Part 3 of 4
EVEN SKINTONE SMOOTHING SERUM MILD 
body and hand (excluding shaving preparations) cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRALCOHOL (UNII: 3K9958V90M)  
INGRLACTIC ACID (UNII: 33X04XA5AT)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRCUCUMBER (UNII: YY7C30VXJT)  
INGRHYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
INGRSALIX ALBA BARK (UNII: 205MXS71H7)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRCAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
INGRSALICYLIC ACID (UNII: O414PZ4LPZ)  
INGRWATER (UNII: 059QF0KO0R)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRPROPANEDIOL (UNII: 5965N8W85T)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRDIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
129.8 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/03/2022
Part 4 of 4
EVEN SKINTONE SMOOTHING MOISTURISER 
moisturizing cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGR3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)  
INGRCETETH-20 (UNII: I835H2IHHX)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRLINOLENIC ACID (UNII: 0RBV727H71)  
INGRPHENYLPROPANOL (UNII: 0F897O3O4M)  
INGRUREA (UNII: 8W8T17847W)  
INGRWATER (UNII: 059QF0KO0R)  
INGRCERAMIDE NP (UNII: 4370DF050B)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRLINOLEIC ACID (UNII: 9KJL21T0QJ)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRGLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRSORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
INGRPEG-75 STEARATE (UNII: OT38R0N74H)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRMETHYLPROPANEDIOL (UNII: N8F53B3R4R)  
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRHYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
175.1 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/03/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02001/03/2022
Labeler - Ultraceuticals US, LLC (117022448)

Revised: 2/2023
Document Id: f5617d06-2e60-498b-e053-2995a90ae1e5
Set id: f5617d06-2e61-498b-e053-2995a90ae1e5
Version: 13
Effective Time: 20230223
 
Ultraceuticals US, LLC