Smoothing TRIO by ULTRACEUTICALS PTY LIMITED / NANOPHASE TECHNOLOGIES CORPORATION Smoothing TRIO

Smoothing TRIO by

Drug Labeling and Warnings

Smoothing TRIO by is a Otc medication manufactured, distributed, or labeled by ULTRACEUTICALS PTY LIMITED, NANOPHASE TECHNOLOGIES CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SMOOTHING TRIO- zinc oxide 
ULTRACEUTICALS PTY LIMITED

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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Smoothing TRIO

Active Ingredients

Zinc Oxide 12% w/w Purpose Sunscreen

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 if reach of children.

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

Stop use and ask a doctor:

If skin rash occurs.

Do not use:

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor:

If skin rash occurs.

For external use only.

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 10a.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.

Allantoin, Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caffeine, Caprylyl Glycol, Caprylyl Methicone, Camosine, 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

Protect the product in this container from excessive heat and direct sun.

Smooting TRIO

Face Cleanser 200ml

Face Serum 30ml

Sunscreen 100ml

Ultra UV Protective Mineral Defence SPF50+ 100ml

Distributed by:

Ultraceuticals Pty Ltd

Suite 2, Level 4, 436-484 Victoria Road

Gladesville NSW 2111 Australia

Toll free US: 833 703 9067

Email: advice@ultraceuticals.com.au

www.ultraceuticals.com

Contains products made in USA and Australia

100% Australian Owned

Store below 77F

KIT-305-001

SMOOTHING TRIO 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10028-024

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10028-024-01	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	08/13/2020	06/30/2021

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	200 mL
Part 2	1 BOTTLE	30 mL
Part 3	1 TUBE	100 mL

Part 1 of 3

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	SALICYLIC ACID (UNII: O414PZ4LPZ)
INGR	EDETATE SODIUM (UNII: MP1J8420LU)
INGR	BENZYL ALCOHOL (UNII: LKG8494WBH)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	FORMIC ACID (UNII: 0YIW783RG1)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	OATMEAL (UNII: 8PI54V663Y)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	LAURETH-4 (UNII: 6HQ855798J)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
INGR	DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
INGR	MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
INGR	GLYCOL DISTEARATE (UNII: 13W7MDN21W)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	CUCUMBER (UNII: YY7C30VXJT)
INGR	SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
INGR	WATER (UNII: 059QF0KO0R)
INGR	SORBIC ACID (UNII: X045WJ989B)
INGR	MALTODEXTRIN (UNII: 7CVR7L4A2D)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		200 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		08/13/2020	06/30/2021

Part 2 of 3

SMOOTHING SERUM MILD 
lotions, oils, powders, and creams liquid

Product Information
Route of Administration	TOPICAL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 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		08/13/2020	06/30/2021

Part 3 of 3

PROTECTIVE MINERAL DEFENCE SPF 50 
zinc oxide cream

Product Information
Item Code (Source)	NDC: 10028-025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	12 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)
PROPANEDIOL (UNII: 5965N8W85T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
LEVOMENOL (UNII: 24WE03BX2T)
CAFFEINE (UNII: 3G6A5W338E)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
DIMETHICONE (UNII: 92RU3N3Y1O)
NIACINAMIDE (UNII: 25X51I8RD4)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
ISODODECANE (UNII: A8289P68Y2)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALLANTOIN (UNII: 344S277G0Z)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CARNOSINE (UNII: 8HO6PVN24W)
PHENYLPROPANOL (UNII: 0F897O3O4M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10028-025-01	100 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
OTC monograph final	part352	08/13/2020	06/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/13/2020	06/30/2021

Labeler - ULTRACEUTICALS PTY LIMITED (744068995)

Establishment
Name	Address	ID/FEI	Business Operations
NANOPHASE TECHNOLOGIES CORPORATION		623502044	manufacture(10028-024)

Revised: 12/2021

Document Id: d24670b6-fc75-3539-e053-2a95a90ad482

34390-5

Set id: acb30143-e28c-3c47-e053-2a95a90a8640

Version: 2

Effective Time: 20211203