FDA.reportPublic FDA data

Mineral SPF 40, Tinted

Manufacturer
Acne Specialists LLC | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
Effective date
2025-12-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:20:53

Label at a glance#

ProductMineral SPF 40, Tinted
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:

INDICATIONS & USAGE SECTION

  • For external use only.
  • Keep out of reach of children.

Warning:

WARNINGS SECTION

  • For external use only
  • 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

Cu

OTHER SAFETY INFORMATION

SAMPLE NOT FOR RESALE

Warning:

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-130385292203156GTIN-13: 0385292203156
EAN-13: 0385292203156
GTIN-12: 385292203156
UPC-A: 385292203156
GTIN storage (14 digits): 00385292203156		Acne Specialists Mineral SPF 40 Tinted SF.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85292-203-15Mineral SPF 40, Tinted1.5 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
85292-20385292-203-15
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
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHICONE92RU3N3Y1OIACT
CI 774911K09F3G675IACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT
ALUMINALMI26O6933IACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT

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
Mineral SPF 40, TintedTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2fb19ed7-8cee-ce80-e063-6394a90ad3dc2025-12-08WarningsExact identifier
ndc (package): 85292-203-15
ndc (product): 85292-203
ndc11 (package): 85292020315
spl id: 457735e2-c1f0-090e-e063-6294a90a542d
spl set id: 2fb19ed7-8cee-ce80-e063-6394a90ad3dc
Mineral SPF 40, TintedTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2fb14c4f-a435-aa6e-e063-6394a90a7d8d2025-12-08WarningsExact identifier
ndc (product): 85292-203
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.