RVR90 FIRM- 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 Firm

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

Firm

Delay the visible effects of time and boost the appearance of skin's firmness and resilience

Facial Cleanser 6.76 fl. oz.

Facial Serum 1.01 fl. oz.

Facial Moisturizer 2.54 fl. oz.

Sunscreen 3.38 fl. oz.

Cosmetic Bag

RVR 90 firm

RVR90 FIRM 
zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73122-065
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73122-065-011 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 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:73122-066
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)  
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)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
WATER (UNII: 059QF0KO0R)  
CAFFEINE (UNII: 3G6A5W338E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73122-066-0199.9 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 BALANCING GEL CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) gel
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
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)  
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
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)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
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
ULTRA C FIRMING SERUM 
body and hand (excluding shaving preparations) lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRASCORBIC ACID (UNII: PQ6CK8PD0R)  
INGRCITRAL (UNII: T7EU0O9VPP)  
INGRSODIUM LACTATE (UNII: TU7HW0W0QT)  
INGRSODIUM METABISULFITE (UNII: 4VON5FNS3C)  
INGRPALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
INGRLACTIC ACID (UNII: 33X04XA5AT)  
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
INGRLAVENDER OIL (UNII: ZBP1YXW0H8)  
INGRYLANG-YLANG OIL (UNII: 8YOY78GNNX)  
INGRCHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRDEXTRAN 1 (UNII: I8LHQ0D645)  
INGRPALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
INGRGERANIOL (UNII: L837108USY)  
INGR.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
INGRDIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
INGRANOGEISSUS LEIOCARPUS BARK (UNII: U5TP1X38RH)  
INGRSODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
INGRCAPROOYL TETRAPEPTIDE-3 (UNII: LZI0HJ3K2R)  
INGRALCOHOL (UNII: 3K9958V90M)  
INGRSODIUM PHOSPHATE (UNII: SE337SVY37)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRPALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
INGRWATER (UNII: 059QF0KO0R)  
INGRPROPANEDIOL (UNII: 5965N8W85T)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRCARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
INGRCAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
INGRMENYANTHES TRIFOLIATA LEAF (UNII: GYG64DIH9P)  
INGRPOLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRHYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
INGRSODIUM SULFITE (UNII: VTK01UQK3G)  
INGRMANDARIN OIL (UNII: NJO720F72R)  
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
Cosmetic01/03/2022
Part 4 of 4
ULTRA HYDRATING LOTION 
lotions, oils, powders, and creams lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRDECYL OLEATE (UNII: ZGR06DO97T)  
INGRSODIUM LACTATE (UNII: TU7HW0W0QT)  
INGRLINOLENIC ACID (UNII: 0RBV727H71)  
INGRSOYBEAN OIL (UNII: 241ATL177A)  
INGRTERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRLACTIC ACID (UNII: 33X04XA5AT)  
INGROLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)  
INGRSQUALENE (UNII: 7QWM220FJH)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRAMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
INGRAMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRUREA (UNII: 8W8T17847W)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRCETEARETH-12 (UNII: 7V4MR24V5P)  
INGRSODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
INGRCHOLESTEROL (UNII: 97C5T2UQ7J)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRPHENYLPROPANOL (UNII: 0F897O3O4M)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRCETYL PALMITATE (UNII: 5ZA2S6B08X)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRBENZOIC ACID (UNII: 8SKN0B0MIM)  
INGRCETEARYL ISONONANOATE (UNII: P5O01U99NI)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
INGRCERAMIDE NP (UNII: 4370DF050B)  
INGRMETHYLPROPANEDIOL (UNII: N8F53B3R4R)  
INGRDICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
INGRWATER (UNII: 059QF0KO0R)  
INGRPOLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
INGRLINOLEIC ACID (UNII: 9KJL21T0QJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
175.1 mL in 1 BOTTLE; Type 0: Not a Combination Product
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 finalpart35201/03/2022
Labeler - Ultraceuticals US, LLC (117022448)

Revised: 2/2023
Document Id: f552334c-2f3f-27a4-e053-2995a90a6495
Set id: f5524264-84d6-5a4f-e053-2a95a90a2115
Version: 12
Effective Time: 20230222
 
Ultraceuticals US, LLC