RVR90 RETEXTURIZE- zinc oxide kit

RVR90 Retexturize by

Drug Labeling and Warnings

RVR90 Retexturize 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

Retexturize

Exfoliate, clarify and refine skin for a refreshed and energized complexion

Facial Cleanser 6.ty 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 RETEXTURIZE 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73122-069

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73122-069-01	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 TUBE	29.8 mL
Part 4	1 TUBE	75.1 mL

Part 1 of 4

ULTRA UV PROTECTIVE MINERAL DEFENCE SPF 50 
zinc oxide cream

Product Information
Item Code (Source)	NDC: 73122-070
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)
PHENYLPROPANOL (UNII: 0F897O3O4M)
WATER (UNII: 059QF0KO0R)
CAFFEINE (UNII: 3G6A5W338E)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73122-070-01	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	01/03/2022

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	LIMONENE, (+)- (UNII: GFD7C86Q1W)
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	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
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)

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

EVEN SKINTONE SMOOTHING SERUM MILD 
body and hand (excluding shaving preparations) cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	ALCOHOL (UNII: 3K9958V90M)
INGR	LACTIC ACID (UNII: 33X04XA5AT)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	CUCUMBER (UNII: YY7C30VXJT)
INGR	HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
INGR	SALIX ALBA BARK (UNII: 205MXS71H7)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
INGR	SALICYLIC ACID (UNII: O414PZ4LPZ)
INGR	WATER (UNII: 059QF0KO0R)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		29.8 mL in 1 TUBE; 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

EVEN SKINTONE SMOOTHING MOISTURISER 
moisturizing cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)
INGR	CETETH-20 (UNII: I835H2IHHX)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	LINOLENIC ACID (UNII: 0RBV727H71)
INGR	PHENYLPROPANOL (UNII: 0F897O3O4M)
INGR	UREA (UNII: 8W8T17847W)
INGR	WATER (UNII: 059QF0KO0R)
INGR	CERAMIDE NP (UNII: 4370DF050B)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	LINOLEIC ACID (UNII: 9KJL21T0QJ)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
INGR	STEARETH-20 (UNII: L0Q8IK9E08)
INGR	POLYSORBATE 60 (UNII: CAL22UVI4M)
INGR	PEG-75 STEARATE (UNII: OT38R0N74H)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	METHYLPROPANEDIOL (UNII: N8F53B3R4R)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		75.1 mL in 1 TUBE; 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)