FDA.reportPublic FDA data

SilkShield All Mineral Sunscreen with TriHex Technology

Manufacturer
Alastin Skincare, Inc. | Wasatch Product Development, LLC | Bentley Labs
Effective date
2022-09-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:50:52

Label at a glance#

ProductSilkShield All Mineral Sunscreen with TriHex Technology
Active ingredientZINC OXIDE
Label structure10 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 two 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 ...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 19.95%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

Warnings

WARNINGS SECTION

  • For external use only.
  • 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 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 two 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

Dimethicone, Cyclopentasiloxane, Polysilicone-11, Squalane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Methyl Methacrylate Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Palmitoyl Hexapeptide-12, Palmitoyl Tripeptide-1, Dunaliella Salina Extract, Ectoin, Hydroxymethoxyphenyl Decanone, Tocopherol, Caprylic/Capric Triglyceride, Stearalkonium Hectorite, Disteardimonium Hectorite, Pentaerythrityl Tetraisostearate, Propylene Carbonate

Other Information

STORAGE AND HANDLING SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by Alastin Skincare®, Inc.
Carlsbad, CA 92010.

PRINCIPAL DISPLAY PANEL - 53.8 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70604-030-02

SilkSHIELD®
ALL MINERAL
SUNSCREEN
with TriHex Technology®

ALASTIN®
SKINCARE

Broad Spectrum SPF 30 Sunscreen
Water Resistant (40 minutes)

1.9 Oz. 53.8g

PRINCIPAL DISPLAY PANEL - 53.8 g Tube Carton
PRINCIPAL DISPLAY PANEL - 53.8 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70604-030-002024-01-30C16284748780-11030e365-6dee-111a-e063-dadaa90a10e2SilkShield ® All Mineral Sunscreen with TriHex Technology ®
70604-030-022024-01-30C16284748780-11030e365-6dee-111a-e063-dadaa90a10e2SilkShield ® All Mineral Sunscreen with TriHex Technology ®
70604-030-042024-01-30C16284748780-11030e365-6dee-111a-e063-dadaa90a10e2SilkShield ® All Mineral Sunscreen with TriHex Technology ®
70604-030-992024-01-30C16284748780-11030e365-6dee-111a-e063-dadaa90a10e2SilkShield ® All Mineral Sunscreen with TriHex Technology ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70604-030-00SilkShield All Mineral Sunscreen with TriHex Technology5 g in 1 TUBECREAM51
70604-030-00SilkShield All Mineral Sunscreen with TriHex Technology12 in 1 CARTONCREAM121
70604-030-02SilkShield All Mineral Sunscreen with TriHex Technology53.8 g in 1 TUBECREAM53.81
70604-030-02SilkShield All Mineral Sunscreen with TriHex Technology1 in 1 CARTONCREAM11
70604-030-04SilkShield All Mineral Sunscreen with TriHex Technology113 g in 1 TUBECREAM1131
70604-030-99SilkShield All Mineral Sunscreen with TriHex Technology12 g in 1 TUBECREAM121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70604-030SILKSHIELD ALL MINERAL SUNSCREEN WITH TRIHEX TECHNOLOGY (ZINC OXIDE) CREAM [ALASTIN SKINCARE, INC.]1Legacy NDC, 6 package rows20220928_ee964348-a8a5-402c-8a96-abe56c031e7f.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70604-03070604-030-02, 70604-030-04, 70604-030-99, 70604-030-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE92RU3N3Y1OIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
SQUALANEGW89575KF9IACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEX75PL53TZJIACT
PALMITOYL HEXAPEPTIDE-12HO4ZT5S86CIACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
DUNALIELLA SALINAF4O1DKI9A6IACT
ECTOINE7GXZ3858RYIACT
1-(4-HYDROXY-3-METHOXYPHENYL)-DECAN-3-ONEBO24ID7E9UIACT
TOCOPHEROLR0ZB2556P8IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
PENTAERYTHRITYL TETRAISOSTEARATE9D7IK5483FIACT
PROPYLENE CARBONATE8D08K3S51EIACT

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
61491293-3ab7-48ba-bb35-a97b8eba669fee964348-a8a5-402c-8a96-abe56c031e7f2022-09-23WarningsExact identifier
spl id: 61491293-3ab7-48ba-bb35-a97b8eba669f
spl set id: ee964348-a8a5-402c-8a96-abe56c031e7f

Reported adverse events (FAERS/openFDA)#

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