FDA.reportPublic FDA data

Tinted Physical Block Sunscreen

Manufacturer
Tucson Acne Clinic | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:20:55

Label at a glance#

ProductTinted Physical Block Sunscreen
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
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:

WARNINGS SECTION

For External Use Only

Keep out of reach of children

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure

INDICATIONS & USAGE SECTION

For external use only

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130385301203153GTIN-13: 0385301203153
EAN-13: 0385301203153
GTIN-12: 385301203153
UPC-A: 385301203153
GTIN storage (14 digits): 00385301203153		Tucson Acne Clinic Tinted Physical Block Sunscreen 203 SF.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85301-203-15Tinted Physical Block Sunscreen1.5 g in 1 PACKETCREAM1.52

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85301-20385301-203-15
58892-203

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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

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
Tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30ddc3d7-76df-3344-e063-6294a90a65ae2025-12-09WarningsExact identifier
ndc (product): 85301-203
Tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30ddf80c-8496-0f47-e063-6394a90afc182025-12-09WarningsExact identifier
ndc (package): 85301-203-15
ndc (product): 85301-203
ndc11 (package): 85301020315
spl id: 4586bfc8-b629-0671-e063-6294a90a2087
spl set id: 30ddf80c-8496-0f47-e063-6394a90afc18
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.