RVR90 CLEAR- zinc oxide kit

RVR90 Clear by

Drug Labeling and Warnings

RVR90 Clear by is a Otc medication manufactured, distributed, or labeled by Ultraceuticals US, LLC, Nanophase Technologies Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PURPOSE

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

• For treatment of acne
• Clears acne blemishes

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

INDICATIONS & USAGE

Stop use and ask a doctor

• If skin rash occurs.

Indications - Ultra Clear Foaming Cleanser

Stop use and ask a doctor:

• if skin irritation becomes severe

Warnings- Ultra Clear Foaming Cleanser

Warnings

For external use only.

When using this product:

• Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

WARNINGS

Warnings

Do not use:

• on damaged or broken skin.

When using this product

• Keep out of eyes. Rinse with water to remove.
• For external use only

Directions

Directions

• Clean the skin thoroughly before applying this product.
• Cover the entire affected area with a thin layer and rinse thoroughly one to three times daily
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
• If dryness or peeling occurs, reduce application to once a day or every other day.
• If going outside, apply Sunscreen after using this product. If Irritation or sensitivity develops, stop use of both product and ask a doctor.

DOSAGE & ADMINISTRATION

Directions

• Apply liberally 15 minutes before sun exposure and at least every 2 hours
• Children under 6 months of age: ask a doctor.

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. - 2p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses
• reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

RVR90 CLEAR 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73122-071

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73122-071-01	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	01/03/2022

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	99.9 mL
Part 2	1 BOTTLE	149.9 mL
Part 3	1 TUBE	49.9 mL
Part 4	1 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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73122-072-01	99.9 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	01/03/2022

Part 2 of 4

ULTRA CLEAR FOAMING CLEANSER 
salicylic acid cream

Product Information
Item Code (Source)	NDC: 73122-073
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73122-073-01	149.9 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/03/2022

Part 3 of 4

ULTRA CLEAR TREATMENT 
salicylic acid lotion

Product Information
Item Code (Source)	NDC: 73122-074
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73122-074-01	49.9 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/03/2022

Part 4 of 4

UITRA HYDRATING LOTION 
lotions, oils, powders, and creams lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	UREA (UNII: 8W8T17847W)
INGR	POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	LINOLEIC ACID (UNII: 9KJL21T0QJ)
INGR	DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
INGR	DECYL OLEATE (UNII: ZGR06DO97T)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	CHOLESTEROL (UNII: 97C5T2UQ7J)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	SOYBEAN OIL (UNII: 241ATL177A)
INGR	AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
INGR	LACTIC ACID (UNII: 33X04XA5AT)
INGR	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
INGR	TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
INGR	CETEARYL ISONONANOATE (UNII: P5O01U99NI)
INGR	SQUALENE (UNII: 7QWM220FJH)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	CETYL PALMITATE (UNII: 5ZA2S6B08X)
INGR	CERAMIDE NP (UNII: 4370DF050B)
INGR	CETEARETH-12 (UNII: 7V4MR24V5P)
INGR	AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
INGR	WATER (UNII: 059QF0KO0R)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	PHENYLPROPANOL (UNII: 0F897O3O4M)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	METHYLPROPANEDIOL (UNII: N8F53B3R4R)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	BENZOIC ACID (UNII: 8SKN0B0MIM)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		75.1 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		01/03/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	01/03/2022

Labeler - Ultraceuticals US, LLC (117022448)