Zinc Oxide SPF 40 Non-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#

ProductZinc Oxide SPF 40 Non-Tinted
Active ingredientZINC OXIDE
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 40 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 Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

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 40 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

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Other Information:

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

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-130385296205040GTIN-13: 0385296205040
EAN-13: 0385296205040
GTIN-12: 385296205040
UPC-A: 385296205040
GTIN storage (14 digits): 00385296205040
The Skin Restoration Zinc Oxide SPF 40 Non-Tinted.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85296-205-04Zinc Oxide SPF 40 Non-Tinted113 g in 1 BOTTLE, PUMPCREAM1132

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85296-20585296-205-04
58892-205

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

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
Zinc Oxide SPF 40 Non-TintedZINC OXIDESkin Restoration Aesthetics2fc68041-acfe-8db6-e063-6294a90ad8ba2025-12-08WarningsExact identifier
ndc (package): 85296-205-04
ndc (product): 85296-205
ndc11 (package): 85296020504
spl id: 45775251-3e47-37c4-e063-6294a90a67a9
spl set id: 2fc68041-acfe-8db6-e063-6294a90ad8ba
Proceuticals Private Label by TiZO non-tinted mineral sunscreen 20% zinc oxideZINC OXIDEFallien Cosmeceuticals, Ltd1bbd14ec-4240-f0c2-e063-6394a90a2c072024-06-25WarningsExact identifier
ndc (product): 58892-205

Reported adverse events (FAERS/openFDA)#

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