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

Brightening TRIO by

Drug Labeling and Warnings

Brightening 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]

BRIGHTENING 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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Brightening TRIO

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 of reach of children.

If product 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 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, 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.

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

Brightening TRIO

Face Cleanser 150mL

Face Serum 30 mL

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@ultraceuticlas.com.au

www.ultraceuticals.com

Contains products made in USA and Australia

100% Australian Owned

Store below 77F

KIT-306-001

BRIGHTENING TRIO 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10028-028

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10028-028-01	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	08/14/2020	02/01/2022

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	100 mL
Part 2	1 TUBE	150 mL
Part 3	1 BOTTLE, PUMP	30 mL

Part 1 of 3

PROTECTIVE MINERAL DEFENCE SPF50 
zinc oxide cream

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		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	08/17/2020	02/01/2022

Part 2 of 3

BRIGHTENING FOAMING CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)
INGR	SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
INGR	GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	CUCUMBER (UNII: YY7C30VXJT)
INGR	LINOLENIC ACID (UNII: 0RBV727H71)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
INGR	LINALOOL, (+/-)- (UNII: D81QY6I88E)
INGR	COCONUT OIL (UNII: Q9L0O73W7L)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	BERGAMOT OIL (UNII: 39W1PKE3JI)
INGR	LEMON OIL (UNII: I9GRO824LL)
INGR	TOCOPHEROL (UNII: R0ZB2556P8)
INGR	GERANIOL (UNII: L837108USY)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	GLYCOL STEARATE (UNII: 0324G66D0E)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	LAVENDER OIL (UNII: ZBP1YXW0H8)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
INGR	SODIUM LACTATE (UNII: TU7HW0W0QT)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	COCONUT ACID (UNII: 40U37V505D)
INGR	LAURIC ACID (UNII: 1160N9NU9U)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	LIME OIL (UNII: UZH29XGA8G)
INGR	LINOLEIC ACID (UNII: 9KJL21T0QJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		150 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		08/17/2020

Part 3 of 3

BRIGHTENING SERUM 
other skin care preparations liquid

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	HYDROXYRESVERATROL (UNII: 6V071CP5CR)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	SODIUM METABISULFITE (UNII: 4VON5FNS3C)
INGR	SODIUM SULFITE (UNII: VTK01UQK3G)
INGR	MELISSA OFFICINALIS FLOWERING TOP (UNII: 5JQG17B06J)
INGR	SALICYLIC ACID (UNII: O414PZ4LPZ)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
INGR	WATER (UNII: 059QF0KO0R)
INGR	ALCOHOL (UNII: 3K9958V90M)
INGR	BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K)
INGR	NIACINAMIDE (UNII: 25X51I8RD4)
INGR	LACTIC ACID (UNII: 33X04XA5AT)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 mL in 1 BOTTLE, PUMP; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		08/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/14/2020	02/01/2022

Labeler - ULTRACEUTICALS PTY LIMITED (744068995)

Establishment
Name	Address	ID/FEI	Business Operations
NANOPHASE TECHNOLOGIES CORPORATION		623502044	manufacture(10028-028)

Revised: 2/2023

Document Id: f56228a8-34b8-6243-e053-2995a90a912a

34390-5

Set id: acde3c83-8827-0430-e053-2a95a90aa156

Version: 2

Effective Time: 20230223