Sheet SPF 30 Mineral

Manufacturer
Vivier Pharma Inc.
Effective date
2024-02-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:08:39

Label at a glance#

ProductSheet SPF 30 Mineral
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Indications and uses

• Helps prevent sunburn and provides a sun protection factor of 30. Broad Spectrum. • Ideal for daily use; can be applied under makeup.

Dosage and administration

Adults and children over 6 months of age: Apply liberally and evenly 15 minutes before sun exposure.  Reapply at least every 2 hours.  Sun Protection Measures: Spending time in the sun increase 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: - limits time in the sun, especial...

Label contents#

Full prescribing information#

Medicinal ingredients

OTC - ACTIVE INGREDIENT SECTION

10% Titanium Dioxide

8% Zinc Oxide

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• Helps prevent sunburn and provides a sun protection factor of 30. Broad Spectrum. • Ideal for daily use; can be applied under makeup.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Other warnings

SPL UNCLASSIFIED SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 6 months of age:

  • Apply liberally and evenly 15 minutes before sun exposure. 
  • Reapply at least every 2 hours.
  •  Sun Protection Measures: Spending time in the sun increase 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: - limits time in the sun, especially from 10 a.m.–2 p.m. ; and wear long-sleeved shirts, pants, hats, and sunglasses.

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature (15-30°C / 59-86°F).

Non-medicinal ingredients

INACTIVE INGREDIENT SECTION

Alumina, Ammonium Acryloyldimethyltaurate/VP Copolymer, Bis-PEG/PPG-16/16 PEG/PPG-16/16 Dimethicone, Butylparaben, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Cetyl Dimethicone, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel Extract, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dipropylene Glycol Dibenzoate, DL-alpha Tocopheryl Acetate, Ethylparaben, Glycerin, Glyceryl Stearate, Green Tea Extract, Iron Oxides CI 77491, Iron Oxides CI 77492, Iron Oxides CI 77499, Isopropyl Titanium Triisostearate, Methylparaben, Phenoxyethanol, Phytic Acid, Polyhydroxystearic Acid, Polysorbate 20, PPG-15 Stearyl Ether Benzoate, Propylene Glycol, Propylparaben, Pyrus Malus (Apple) Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Sodium Ascorbyl Phosphate, Sodium Hydroxide, t-Butyl Alcohol, Triethoxycaprylylsilane, VP/Eicosene Copolymer, Water/Eau, Xanthan Gum.

Questions?

OTC - QUESTIONS SECTION

Call 1 877 484 8437

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel2Label2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67226-2232-6Sheet SPF 30 Mineral1 in 1 BOXLOTION13
67226-2232-6Sheet SPF 30 Mineral60 mL in 1 BOTTLELOTION603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67226-2232SHEET SPF 30 MINERAL (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VIVIER PHARMA INC.]3Current NDC, Legacy NDC, 2 package rows20240215_bbb5b87c-d641-3ba2-e053-2a95a90a0f70.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67226-223267226-2232-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 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
Sheet SPF 30 MineralTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma Inc.bbb5b87c-d641-3ba2-e053-2a95a90a0f702024-02-14WarningsExact identifier
ndc (package): 67226-2232-6
ndc (product): 67226-2232
ndc11 (package): 67226223206
spl id: 1159e6f6-423b-51ac-e063-6394a90ab0a4
spl set id: bbb5b87c-d641-3ba2-e053-2a95a90a0f70

Reported adverse events (FAERS/openFDA)#

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