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 1

Trio2a

BRIGHTENING TRIO 
zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10028-028
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10028-028-011 in 1 KIT; Type 1: Convenience Kit of Co-Package08/14/202002/01/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 100 mL
Part 21 TUBE 150 mL
Part 31 BOTTLE, PUMP 30 mL
Part 1 of 3
PROTECTIVE MINERAL DEFENCE SPF50 
zinc oxide cream
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION12 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1100 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/17/202002/01/2022
Part 2 of 3
BRIGHTENING FOAMING CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) liquid
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRSODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)  
INGRSODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
INGRGERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRCUCUMBER (UNII: YY7C30VXJT)  
INGRLINOLENIC ACID (UNII: 0RBV727H71)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGR.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRBERGAMOT OIL (UNII: 39W1PKE3JI)  
INGRLEMON OIL (UNII: I9GRO824LL)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRGERANIOL (UNII: L837108USY)  
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRGLYCOL STEARATE (UNII: 0324G66D0E)  
INGRPROPANEDIOL (UNII: 5965N8W85T)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRCAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRLAVENDER OIL (UNII: ZBP1YXW0H8)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRBUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
INGRSODIUM LACTATE (UNII: TU7HW0W0QT)  
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRCOCONUT ACID (UNII: 40U37V505D)  
INGRLAURIC ACID (UNII: 1160N9NU9U)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRLIME OIL (UNII: UZH29XGA8G)  
INGRLINOLEIC ACID (UNII: 9KJL21T0QJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1150 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic08/17/2020
Part 3 of 3
BRIGHTENING SERUM 
other skin care preparations liquid
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRHYDROXYRESVERATROL (UNII: 6V071CP5CR)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRSODIUM METABISULFITE (UNII: 4VON5FNS3C)  
INGRSODIUM SULFITE (UNII: VTK01UQK3G)  
INGRMELISSA OFFICINALIS FLOWERING TOP (UNII: 5JQG17B06J)  
INGRSALICYLIC ACID (UNII: O414PZ4LPZ)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRHYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRCAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
INGRWATER (UNII: 059QF0KO0R)  
INGRALCOHOL (UNII: 3K9958V90M)  
INGRBELLIS PERENNIS FLOWER (UNII: 26I94X9A1K)  
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRLACTIC ACID (UNII: 33X04XA5AT)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 mL in 1 BOTTLE, PUMP; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic08/17/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/14/202002/01/2022
Labeler - ULTRACEUTICALS PTY LIMITED (744068995)
Establishment
NameAddressID/FEIBusiness Operations
NANOPHASE TECHNOLOGIES CORPORATION623502044manufacture(10028-028)

Revised: 2/2023