FDA.reportPublic FDA data

SHADED

Manufacturer
Potency No. 710 LLC | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:21:35

Label at a glance#

ProductSHADED
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Dosage and administration

Apply liberally 15 minutes before sun exposure

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8% Zinc Oxide 3.8%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Warning:

INDICATIONS & USAGE SECTION

For External Use Only

Warning:

WARNINGS SECTION

  • For External Use Only
  • Keep Out of Reach of Children

Warning:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure

INACTIVE INGREDIENT SECTION

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

OTHER SAFETY INFORMATION

SAMPLE NOT FOR RESALE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130385319203152GTIN-13: 0385319203152
EAN-13: 0385319203152
GTIN-12: 385319203152
UPC-A: 385319203152
GTIN storage (14 digits): 00385319203152		Potency 710 SHADED 203 SF.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85319-203-15SHADED1.5 g in 1 PACKETCREAM1.52

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85319-20385319-203-15
58892-203

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
ALUMINALMI26O6933IACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
CI 774911K09F3G675IACT
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
CI 77499XM0M87F357IACT
CI 77492EX438O2MRTIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC3117e138-83a1-0931-e063-6394a90abe432025-12-10WarningsExact identifier
ndc (product): 85319-203
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC31188175-a4ca-449f-e063-6394a90a3c052025-12-10WarningsExact identifier
ndc (package): 85319-203-15
ndc (product): 85319-203
ndc11 (package): 85319020315
spl id: 459be997-2950-a7cf-e063-6394a90ad491
spl set id: 31188175-a4ca-449f-e063-6394a90a3c05
PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD0b62062d-b77e-4e6c-b3ab-b35ab24db7cb2024-06-04WarningsExact identifier
ndc (product): 58892-203

Reported adverse events (FAERS/openFDA)#

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