FDA.reportPublic FDA data

Daily Beauty Regimen with TriHex Technology

Manufacturer
Alastin Skincare, Inc.
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:07:01

Label at a glance#

ProductDaily Beauty Regimen with TriHex Technology
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply: After 40 minutes of swimming or sweating Immediately after towel drying 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 pr...

Storage and handling

Protect the product in this container from excessive heat and direct sun. Store at room temperature 15° - 30°C (59° - 86°F).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Titanium Dioxide 8.9%Sunscreen
Zinc Oxide 3.4%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.

Warnings

WARNINGS SECTION

  • For external use only.

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

  • When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Reapply:
    • After 40 minutes of swimming or sweating
    • Immediately after towel drying
    • 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 time in the sun, especially from 10am - 2pm
    • Wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Water/Aqua/Eau, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Butylene Glycol, Aluminum Hydroxide, Stearic Acid, Thermus Thermophillus Ferment, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride, Camellia Sinensis Leaf Extract, Hydroxymethoxyphenyl Decanone, Dunaliella Salina Extract, Asteriscus Graveolens Flower/Fruit/Leaf/Stem Extract, Ergothioneine, Ectoin, Squalane, Glycerin, Caprylic/Capric Triglyceride, Tocopherol, Tocopheryl Acetate, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Sodium Citrate, Potassium Sorbate, Dipropylene Glycol, Phenoxyethanol, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499).

Other Information

STORAGE AND HANDLING SECTION

  • Protect the product in this container from excessive heat and direct sun. Store at room temperature 15° - 30°C (59° - 86°F).

SPL UNCLASSIFIED SECTION

Distributed by
Alastin Skincare® Inc., a Galderma Company
Carlsbad, CA 92010

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALASTIN®
SKINCARE

DAILY BEAUTY
REGIMEN

with TriHex Technology®

Designed to help restore and renew skin to
maintain a healthy, youthful appearance.

PRINCIPAL DISPLAY PANEL - Kit Carton
PRINCIPAL DISPLAY PANEL - Kit Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70604-011-00Daily Beauty Regimen with TriHex Technology12 g in 1 TUBECREAM12 g0.089 g in 1g1
70604-050-00Daily Beauty Regimen with TriHex Technology1 in 1 CARTONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70604-011DAILY BEAUTY REGIMEN WITH TRIHEX TECHNOLOGY (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ALASTIN SKINCARE, INC.]1Unmatched20240112_4092c96d-ed3f-4ffd-b25f-19abfe46c73a.zip
70604-050DAILY BEAUTY REGIMEN WITH TRIHEX TECHNOLOGY (TITANIUM DIOXIDE AND ZINC OXIDE) KIT [ALASTIN SKINCARE, INC.]12 package rows20240112_4092c96d-ed3f-4ffd-b25f-19abfe46c73a.zip

Products#

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

DailyMed product names page 1 of 3 · 97 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70604-05070604-050-00
70604-01170604-011-00

Ingredients#

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

DailyMed ingredient rows page 1 of 4 · 136 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
THERMUS THERMOPHILUS LYSATE775R692494IACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
SODIUM CHLORIDE451W47IQ8XIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
1-(4-HYDROXY-3-METHOXYPHENYL)-DECAN-3-ONEBO24ID7E9UIACT
DUNALIELLA SALINAF4O1DKI9A6IACT
ERGOTHIONEINEBDZ3DQM98WIACT
ECTOINE7GXZ3858RYIACT
SQUALANEGW89575KF9IACT
GLYCERINPDC6A3C0OXIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEX75PL53TZJIACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
DIPROPYLENE GLYCOLE107L85C40IACT
PHENOXYETHANOLHIE492ZZ3TIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
WATER059QF0KO0RINGR
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UINGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
OATZ6J799EAJKINGR
ODETIGLUCANQ6X9CNN54XINGR

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
3414157e-6c31-4152-8042-3f53cb216c744092c96d-ed3f-4ffd-b25f-19abfe46c73a2023-12-20WarningsExact identifier
spl id: 3414157e-6c31-4152-8042-3f53cb216c74
spl set id: 4092c96d-ed3f-4ffd-b25f-19abfe46c73a

Reported adverse events (FAERS/openFDA)#

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