FDA.reportPublic FDA data

Smoothing TRIO

Manufacturer
ULTRACEUTICALS PTY LIMITED | NANOPHASE TECHNOLOGIES CORPORATION
Effective date
2020-08-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:18:13

Label at a glance#

ProductSmoothing 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.

Dosage and administration

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....

Label contents#

Full prescribing information#

Active Ingredients

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 if reach of children.

If products 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.

INACTIVE INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 1smoothing Trio 1

Smoothing Trio 2Smoothing Trio 2

Products#

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

DailyMed product names page 1 of 2 · 63 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10028-02410028-024-01
10028-02510028-025-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 72 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 500761NX2Q08YIACT
PROPANEDIOL5965N8W85TIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ZINC OXIDESOI2LOH54ZACTIM
TRICETEARETH-4 PHOSPHATE69534Y66NOIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
LEVOMENOL24WE03BX2TIACT
CAFFEINE3G6A5W338EIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
DIMETHICONE92RU3N3Y1OIACT
NIACINAMIDE25X51I8RD4IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
ISODODECANEA8289P68Y2IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALLANTOIN344S277G0ZIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CARNOSINE8HO6PVN24WIACT
PHENYLPROPANOL0F897O3O4MIACT
SODIUM HYDROXIDE55X04QC32IIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
SODIUM CHLORIDE451W47IQ8XIACT
SALICYLIC ACIDO414PZ4LPZINGR
EDETATE SODIUMMP1J8420LUINGR
BENZYL ALCOHOLLKG8494WBHINGR
ALOE VERA LEAFZY81Z83H0XINGR
FORMIC ACID0YIW783RG1INGR
SODIUM HYDROXIDE55X04QC32IINGR
OATMEAL8PI54V663YINGR
PROPANEDIOL5965N8W85TINGR
LAURETH-46HQ855798JINGR
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0INGR
GLYCERINPDC6A3C0OXINGR
SODIUM LAUROYL SARCOSINATE632GS99618INGR
CITRIC ACID MONOHYDRATE2968PHW8QPINGR
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VINGR
DECYL GLUCOSIDEZ17H97EA6YINGR

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
d24670b6-fc75-3539-e053-2a95a90ad482acb30143-e28c-3c47-e053-2a95a90a86402021-12-03WarningsExact identifier
spl set id: acb30143-e28c-3c47-e053-2a95a90a8640

Reported adverse events (FAERS/openFDA)#

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