RVR90 HYDRATING- zinc oxide kit

RVR90 Hydrating by

Drug Labeling and Warnings

RVR90 Hydrating 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

Hydrating

Boost Skin's hydration levels for smoother, more youthful looking skin

Facial Cleanser 5.07 fl. oz.

Facial Serum 1.01 fl. oz.

Facial Moisturizer 2.54 fl. oz.

Sunscreen 3.38 fl. oz.

Cosmetics Bag

INGREDIENTS AND APPEARANCE

RVR90 HYDRATING 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73122-063

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73122-063-01	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	12/20/2021

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	99.9 mL
Part 2	1 BOTTLE	149.9 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: 73122-064
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)
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)
ISODODECANE (UNII: A8289P68Y2)
TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)
PHENYLPROPANOL (UNII: 0F897O3O4M)
WATER (UNII: 059QF0KO0R)
CAFFEINE (UNII: 3G6A5W338E)
LEVOMENOL (UNII: 24WE03BX2T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73122-064-01	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 BRIGHTENING FOAMING CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	COCONUT OIL (UNII: Q9L0O73W7L)
INGR	CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	LINOLENIC ACID (UNII: 0RBV727H71)
INGR	.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	GLYCOL STEARATE (UNII: 0324G66D0E)
INGR	LAURIC ACID (UNII: 1160N9NU9U)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	SODIUM LACTATE (UNII: TU7HW0W0QT)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	LIME OIL, COLD PRESSED (UNII: UZH29XGA8G)
INGR	LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
INGR	LAVENDER OIL (UNII: ZBP1YXW0H8)
INGR	WATER (UNII: 059QF0KO0R)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
INGR	SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	COCONUT ACID (UNII: 40U37V505D)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	LINOLEIC ACID (UNII: 9KJL21T0QJ)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	BERGAMOT OIL (UNII: 39W1PKE3JI)
INGR	GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	CUCUMBER (UNII: YY7C30VXJT)
INGR	GERANIOL (UNII: L837108USY)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		149.9 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		12/20/2021

Part 3 of 4

ULTRA B2 HYDRATING SERUM 
body and hand (excluding shaving preparations) cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	UREA (UNII: 8W8T17847W)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	SORBIC ACID (UNII: X045WJ989B)
INGR	SALICYLIC ACID (UNII: O414PZ4LPZ)
INGR	CUCUMBER (UNII: YY7C30VXJT)
INGR	TREHALOSE (UNII: B8WCK70T7I)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	WATER (UNII: 059QF0KO0R)
INGR	BENZYL ALCOHOL (UNII: LKG8494WBH)

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		12/20/2021

Part 4 of 4

ULTRA MOISTURISER CREAM 
lotions, oils, powders, and creams cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	PHENYLPROPANOL (UNII: 0F897O3O4M)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	METHYLPROPANEDIOL (UNII: N8F53B3R4R)
INGR	STEARETH-20 (UNII: L0Q8IK9E08)
INGR	SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	PEG-75 STEARATE (UNII: OT38R0N74H)
INGR	COCONUT OIL (UNII: Q9L0O73W7L)
INGR	VANILLIN (UNII: CHI530446X)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	LINOLEIC ACID (UNII: 9KJL21T0QJ)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	LINOLENIC ACID (UNII: 0RBV727H71)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	CETETH-20 (UNII: I835H2IHHX)
INGR	POLYSORBATE 60 (UNII: CAL22UVI4M)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	UREA (UNII: 8W8T17847W)
INGR	CHOLESTEROL (UNII: 97C5T2UQ7J)
INGR	CERAMIDE NP (UNII: 4370DF050B)
INGR	LACTIC ACID (UNII: 33X04XA5AT)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
INGR	WATER (UNII: 059QF0KO0R)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	SODIUM LACTATE (UNII: TU7HW0W0QT)

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		12/20/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/20/2021

Labeler - Ultraceuticals US, LLC (117022448)