NeoStrata Sheer Physical Protection

Manufacturer
NeoStrata Company Inc.
Effective date
2025-01-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:52:03

Label at a glance#

ProductNeoStrata Sheer Physical Protection Sunscreen Broad Spectrum SPF 50
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure10 sections

Indications and uses

Helps prevent 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

Shake vigorously for 15 seconds before each use Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply sunscreen 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 of 15...

Storage and handling

Store at 15°C-30°C (59°F-86°F) Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (w/w)

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 7%
Zinc Oxide 6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent 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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this productkeep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctorif rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake vigorously for 15 seconds before each use
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply sunscreen 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 of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m.–2 p.m.
    • Wear long-sleeve shirts, pants, hats, and sunglasses

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Dimethicone, Isododecane, C12-15 Alkyl Benzoate, Hydrogenated Polydecene, Butyloctyl Salicylate, Gluconolactone, Styrene/Acrylates Copolymer, Alumina, Ammonium Hydroxide, Lactobionic Acid, PEG-9 Polydimethylsiloxyethyl Dimethicone, Phenethyl Benzoate, Nylon-12, DL-Alpha Tocopheryl Acetate, Epigallocatechin Gallate, Polyhydroxystearic Acid, Ethylhexylglycerin, Tocopherol, Dimethicone/PEG-10/ 15 Crosspolymer, Hydrogen Dimethicone, Isohexadecane, Sodium Citrate, Disteardimonium Hectorite, Magnesium Sulfate, Dipropylene Glycol, Propylene Carbonate, Sodium Bisulfite, Triethoxycaprylylsilane, Phenoxyethanol, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499).

Other information

STORAGE AND HANDLING SECTION

  • Store at 15°C-30°C (59°F-86°F)
  • Protect this product from excessive heat and direct sun

Questions?

OTC - QUESTIONS SECTION

1-800-628-9904

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEOSTRATA ®

DEFEND
PROTECTION AGAINST
ENVIRONMENTAL STRESSORS

Sheer Physical Protection
Sunscreen Broad Spectrum SPF 50
Matte-finish tinted sunscreen PA++++

50 mL / 1.7 FL OZ

Principal Display Panel - 50 mL Bottle Carton
Principal Display Panel - 50 mL Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58414-0018-12022-03-09C16284748780-19d75b9d1-013b-f424-e053-dadaa90a57ceNeoStrata ® Sheer Physical Protection
58414-0018-12020-01-31C16284748780-19d75b9d1-013b-f424-e053-dadaa90a57ceNeoStrata ® Sheer Physical Protection

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58414-0018NEOSTRATA SHEER PHYSICAL PROTECTION SUNSCREEN BROAD SPECTRUM SPF 50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [NEOSTRATA COMPANY INC.]4Legacy NDC20250112_30042428-a0d4-4259-a678-6f40d3bffe41.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58414-001858414-0018-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
42c22e99-fd9b-993d-e063-6294a90a86f930042428-a0d4-4259-a678-6f40d3bffe412025-11-04WarningsExact identifier
spl set id: 30042428-a0d4-4259-a678-6f40d3bffe41

Reported adverse events (FAERS/openFDA)#

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