FDA.reportPublic FDA data

Brightening TRIO

Manufacturer
ULTRACEUTICALS PTY LIMITED | NANOPHASE TECHNOLOGIES CORPORATION
Effective date
2020-08-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:18:14

Label at a glance#

ProductBrightening TRIO
Active ingredientZINC OXIDE
Label structure9 sections

Indications and 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.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12% w/w Purpose Sunscreen

Uses

OTC - PURPOSE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

INDICATIONS & USAGE SECTION

Stop use and ask a doctor:

If skin rash occurs.

WARNINGS SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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.

INACTIVE INGREDIENT SECTION

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.

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 1Brightening Trio 1

Trio2aTrio2a

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 69 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10028-02810028-028-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 76 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XIACT
ZINC OXIDESOI2LOH54ZACTIM
CAFFEINE3G6A5W338EIACT
CARNOSINE8HO6PVN24WIACT
NIACINAMIDE25X51I8RD4IACT
POLYETHYLENE GLYCOL 500761NX2Q08YIACT
ALLANTOIN344S277G0ZIACT
LEVOMENOL24WE03BX2TIACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PROPANEDIOL5965N8W85TIACT
SODIUM HYDROXIDE55X04QC32IIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
TRICETEARETH-4 PHOSPHATE69534Y66NOIACT
WATER059QF0KO0RIACT
PHENYLPROPANOL0F897O3O4MIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
ISODODECANEA8289P68Y2IACT
METHYLPROPANEDIOLN8F53B3R4RIACT
DIMETHICONE92RU3N3Y1OIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
WATER059QF0KO0RINGR
SODIUM COCOYL GLYCINATEXLU9KH03XMINGR
SODIUM METHYL COCOYL TAURATEJVL98CG53GINGR
GERANIUM OIL, ALGERIAN TYPE5Q1I94P4WGINGR
SODIUM BENZOATEOJ245FE5EUINGR
CUCUMBERYY7C30VXJTINGR
LINOLENIC ACID0RBV727H71INGR
POTASSIUM SORBATE1VPU26JZZ4INGR
.BETA.-CITRONELLOL, (R)-P01OUT964KINGR
LINALOOL, (+/-)-D81QY6I88EINGR
COCONUT OILQ9L0O73W7LINGR
SODIUM HYDROXIDE55X04QC32IINGR
BERGAMOT OIL39W1PKE3JIINGR
LEMON OILI9GRO824LLINGR
TOCOPHEROLR0ZB2556P8INGR

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f56228a8-34b8-6243-e053-2995a90a912aacde3c83-8827-0430-e053-2a95a90aa1562023-02-23WarningsExact identifier
spl set id: acde3c83-8827-0430-e053-2a95a90aa156

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.