FDA.reportPublic FDA data

Mineral Sunscreen SPF 40 Tinted

Manufacturer
Skin Restoration Aesthetics | 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 Sunscreen SPF 40 Tinted
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 sections

Indications and uses

Helps prevents sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

• Apply liberally 15 minutes before sun exposure. • Reapply: • After 80 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • Children under 6 months: 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...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8%

Zinc Oxide 3.8%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

Helps prevents sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medicalhelp or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

• Apply liberally 15 minutes before sun exposure.

• Reapply:

• After 80 minutes of swimming or sweating

• Immediately after towel drying

• At least every 2 hours

• Children under 6 months: 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 10 am-2 pm

• Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

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 Information:

OTHER SAFETY INFORMATION

• Protect this product from excessive heat and direct sun

• May stain some fabrics

• PA +++

Warning:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130385296203503GTIN-13: 0385296203503
EAN-13: 0385296203503
GTIN-12: 385296203503
UPC-A: 385296203503
GTIN storage (14 digits): 00385296203503		The Skin Restoration Mineral Sunscreen SPF 40 Tinted.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85296-203-50Mineral Sunscreen SPF 40 Tinted50 g in 1 BOTTLE, PUMPCREAM502

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
85296-20385296-203-50
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
CYCLOPENTASILOXANE0THT5PCI0RIACT
CI 774911K09F3G675IACT
ZINC OXIDESOI2LOH54ZACTIB
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONOL (2000 CST)T74O12AN6YIACT
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
CYCLOHEXASILOXANEXHK3U310BAIACT
ALUMINALMI26O6933IACT
DIMETHICONE CROSSPOLYMERUF7620L1W6IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
HYDROGEN DIMETHICONE (20 CST)12Z59IF64NIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Sunscreen SPF 40 TintedTITANIUM DIOXIDE, ZINC OXIDESkin Restoration Aesthetics2fc55e8c-41d6-15cc-e063-6394a90ac5432025-12-08WarningsExact identifier
ndc (package): 85296-203-50
ndc (product): 85296-203
ndc11 (package): 85296020350
spl id: 45775092-9f95-3865-e063-6294a90a7579
spl set id: 2fc55e8c-41d6-15cc-e063-6394a90ac543
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.