RVR90 FIRM- zinc oxide kit

RVR90 Firm by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Zinc Oxide 12% w/w Sunscreen

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.

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 rash occurs

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

DOSAGE & ADMINISTRATION

Directions

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

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:

• after 40 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours

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

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

INGREDIENTS AND APPEARANCE

RVR90 FIRM 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73122-065

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73122-065-01	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 BOTTLE	99.9 mL
Part 2	1 BOTTLE	199 mL
Part 3	1 BOTTLE	29.9 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: 73122-066
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73122-066-01	99.9 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
OTC monograph final	part352	12/20/2021

Part 2 of 4

ULTRA BALANCING GEL CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) gel

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
INGR	HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
INGR	GLYCOL DISTEARATE (UNII: 13W7MDN21W)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	WATER (UNII: 059QF0KO0R)
INGR	CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
INGR	SALICYLIC ACID (UNII: O414PZ4LPZ)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	BENZYL ALCOHOL (UNII: LKG8494WBH)
INGR	FORMIC ACID (UNII: 0YIW783RG1)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	CUCUMBER (UNII: YY7C30VXJT)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
INGR	OATMEAL (UNII: 8PI54V663Y)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	LAURETH-4 (UNII: 6HQ855798J)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	SORBIC ACID (UNII: X045WJ989B)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		199.9 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

Part 3 of 4

ULTRA C FIRMING SERUM 
body and hand (excluding shaving preparations) lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	ASCORBIC ACID (UNII: PQ6CK8PD0R)
INGR	CITRAL (UNII: T7EU0O9VPP)
INGR	SODIUM LACTATE (UNII: TU7HW0W0QT)
INGR	SODIUM METABISULFITE (UNII: 4VON5FNS3C)
INGR	PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
INGR	LACTIC ACID (UNII: 33X04XA5AT)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	LAVENDER OIL (UNII: ZBP1YXW0H8)
INGR	YLANG-YLANG OIL (UNII: 8YOY78GNNX)
INGR	CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	DEXTRAN 1 (UNII: I8LHQ0D645)
INGR	PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	GERANIOL (UNII: L837108USY)
INGR	.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
INGR	DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
INGR	ANOGEISSUS LEIOCARPUS BARK (UNII: U5TP1X38RH)
INGR	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
INGR	CAPROOYL TETRAPEPTIDE-3 (UNII: LZI0HJ3K2R)
INGR	ALCOHOL (UNII: 3K9958V90M)
INGR	SODIUM PHOSPHATE (UNII: SE337SVY37)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
INGR	WATER (UNII: 059QF0KO0R)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
INGR	POLYSORBATE 60 (UNII: CAL22UVI4M)
INGR	CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
INGR	MENYANTHES TRIFOLIATA LEAF (UNII: GYG64DIH9P)
INGR	POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
INGR	SODIUM SULFITE (UNII: VTK01UQK3G)
INGR	MANDARIN OIL (UNII: NJO720F72R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		29.9 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

Part 4 of 4

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

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	DECYL OLEATE (UNII: ZGR06DO97T)
INGR	SODIUM LACTATE (UNII: TU7HW0W0QT)
INGR	LINOLENIC ACID (UNII: 0RBV727H71)
INGR	SOYBEAN OIL (UNII: 241ATL177A)
INGR	TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	LACTIC ACID (UNII: 33X04XA5AT)
INGR	OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X)
INGR	SQUALENE (UNII: 7QWM220FJH)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
INGR	AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	UREA (UNII: 8W8T17847W)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	CETEARETH-12 (UNII: 7V4MR24V5P)
INGR	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
INGR	CHOLESTEROL (UNII: 97C5T2UQ7J)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	PHENYLPROPANOL (UNII: 0F897O3O4M)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	CETYL PALMITATE (UNII: 5ZA2S6B08X)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	BENZOIC ACID (UNII: 8SKN0B0MIM)
INGR	CETEARYL ISONONANOATE (UNII: P5O01U99NI)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	CERAMIDE NP (UNII: 4370DF050B)
INGR	METHYLPROPANEDIOL (UNII: N8F53B3R4R)
INGR	DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
INGR	WATER (UNII: 059QF0KO0R)
INGR	POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
INGR	LINOLEIC ACID (UNII: 9KJL21T0QJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		75.1 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
Cosmetic		12/20/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/03/2022

Labeler - Ultraceuticals US, LLC (117022448)