RVR90 CLEAR- 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 Clear

Active Ultra UV mineral Defense SPF 50

Active Ingredients Purpose

Zinc Oxide 12 w/w Sunscreen

Active ingredient- Ultra Clear Foaming Cleanser

Active ingredients Purpose

Salicylic Acid 0.5% Acne Treatment

Active ingredients- Ultra Clear Treatment Lotion

Active ingredients Purpose

Salicylic Acid 2% w/w Acne Treatment

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.

Purpose

Uses

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

Indications - Ultra Clear Foaming Cleanser

Stop use and ask a doctor:

Warnings- Ultra Clear Foaming Cleanser

Warnings

For external use only.

When using this product:

Warnings

Do not use:

When using this product

Directions

Directions

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 - Ultra Clear Treatment Lotion

Inactive Ingredients:

Water/Eau, PPG-15 Stearyl Ether, Arginine, Glycerin, Mandelic Acid, Niacinamide, Tribehenin PEG-20 Esters, Ethoxydiglycol, Methylpropanediol, Cetearyl Alcohol, Disodium Laurimodipropionate Tocopheryl Phosphates, Dimethicone, Bentonite, Caprylyl Glycol, Allantoin, Bisabolol, Hydrated Silica, Sodium PCA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate Crosspolymer-6 Xanthan Gum, Disodium EDTA, Phenylpropanol, Eucalyptus Globulus Leaf Oil, Fusanus Spicata Wood Oil, Phenoxyethanol, Eugenia Caryophyllus (Clove) Bud Oil, Aloe Barbadensis Leaf Juice Powder, Maltodextrin, T-Butyl Alcohol, Benzoic Acid, Dehydroacetic Acid.

Inactive ingredients- Ultra Clear Foaming Cleanser

Inactive Ingredients

Water/Eau, Polysorbate 20, Methylpropanediol, Decyl Glucoside, PEG-120 Methyl Glucose Dioleate, Lactic Acid, Hamamelis Virginiana Water, Cocamidopropyl Betaine, Sodium Hydroxide, Mandelic Acid, Caprylyl Glycol, Sodium Lauroyl Lactylate, Allantoin, Sodium Chloride, Sodium PCA, Disodium EDTA, Phenylpropanol, Niacinamide, Disodium Lauriminodipropionate Tocopheryl Phosphates, Eucalyptus Globulus Leaf Oil, Fusanus Spicatus Wood Oil, Eugenia Caryophyllus (Clove) Bud Oil, Sodium Benzoate, Benzoic acid, Phenoxyethanol, Dehydroacetic Acid.

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

Clear

Visibly decongest and smooth skin while reducing future breakouts

Acne Facial Cleanser 5.07 fl. oz.

Acne Treatment Lotion 1.69 fl. oz.

Facial Moisturizer 2.54 fl. oz.

Sunscreen 3.38 fl. oz.

Cosmetic Bag

Belly band clear

RVR90 CLEAR 
zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73122-071
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73122-071-011 in 1 KIT; Type 1: Convenience Kit of Co-Package01/03/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 99.9 mL
Part 21 BOTTLE 149.9 mL
Part 31 TUBE 49.9 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:73122-072
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:73122-072-0199.9 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02001/03/2022
Part 2 of 4
ULTRA CLEAR FOAMING CLEANSER 
salicylic acid cream
Product Information
Item Code (Source)NDC:73122-073
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
ALLANTOIN (UNII: 344S277G0Z)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
LACTIC ACID (UNII: 33X04XA5AT)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
MANDELIC ACID (UNII: NH496X0UJX)  
CLOVE OIL (UNII: 578389D6D0)  
SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
NIACINAMIDE (UNII: 25X51I8RD4)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73122-073-01149.9 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/03/2022
Part 3 of 4
ULTRA CLEAR TREATMENT 
salicylic acid lotion
Product Information
Item Code (Source)NDC:73122-074
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
WATER (UNII: 059QF0KO0R)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)  
ARGININE (UNII: 94ZLA3W45F)  
POLYPROPYLENE GLYCOL 15 STEARYL ETHER (UNII: 1II18XLS1L)  
GLYCERIN (UNII: PDC6A3C0OX)  
MANDELIC ACID (UNII: NH496X0UJX)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)  
BENTONITE (UNII: A3N5ZCN45C)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ALLANTOIN (UNII: 344S277G0Z)  
LEVOMENOL (UNII: 24WE03BX2T)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CLOVE OIL (UNII: 578389D6D0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73122-074-0149.9 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/03/2022
Part 4 of 4
UITRA HYDRATING LOTION 
lotions, oils, powders, and creams lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRUREA (UNII: 8W8T17847W)  
INGRPOLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRLINOLEIC ACID (UNII: 9KJL21T0QJ)  
INGRDICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
INGRDECYL OLEATE (UNII: ZGR06DO97T)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRCHOLESTEROL (UNII: 97C5T2UQ7J)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGROLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)  
INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
INGRSOYBEAN OIL (UNII: 241ATL177A)  
INGRAMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
INGRLACTIC ACID (UNII: 33X04XA5AT)  
INGRSODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
INGRTERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
INGRCETEARYL ISONONANOATE (UNII: P5O01U99NI)  
INGRSQUALENE (UNII: 7QWM220FJH)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRCETYL PALMITATE (UNII: 5ZA2S6B08X)  
INGRCERAMIDE NP (UNII: 4370DF050B)  
INGRCETEARETH-12 (UNII: 7V4MR24V5P)  
INGRAMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
INGRWATER (UNII: 059QF0KO0R)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
INGRPHENYLPROPANOL (UNII: 0F897O3O4M)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRMETHYLPROPANEDIOL (UNII: N8F53B3R4R)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRBENZOIC ACID (UNII: 8SKN0B0MIM)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
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
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: 9/2023
Document Id: 04514f59-79cc-57e6-e063-6294a90aa644
Set id: d6963037-dfb1-f37d-e053-2a95a90ac7a0
Version: 4
Effective Time: 20230901
 
Ultraceuticals US, LLC