ZINC OXIDE - Grace and Fire USA Inc.

Manufacturer
Grace and Fire USA Inc.
Effective date
2026-06-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-07-17 21:34:44

Label at a glance#

ProductUltra Violette Velvet Screen Blurring Mineral Skinscreen Broad Spectrum SPF 40
Active ingredientZINC OXIDE
Label structure8 sections

Dosage and administration

Directions for Sunscreen Use ● apply liberally and evenly 15 minutes before sun exposure ● reapply at least every 2 hours ● use a water resistant sunscreen if swimming or sweating ● 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 measur...

Storage and handling

Protect this product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 25%

OTC - PURPOSE SECTION

SUNSCREEN

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 SECTION

.

For External Use Only

OTC - DO NOT USE SECTION

For External Use Only

Do not use on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Rash occurs

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

Directions for Sunscreen Use

● apply liberally and evenly 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● 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 a.m. – 2 p.m.

● wear long-sleeved shirts, pants, hats, and sunglasses

● children under 6 months of age: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Coco-Caprylate/Caprate, Dicaprylyl Carbonate, Caprylic/ Capric Triglyceride, Silica, Copernicia Cerfera (Carnauba) Wax, Microcrystalline Cellulose, Stearalkonium Hectorite, Glycerin, Triethoxycaprylylsilane, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Saccharide lsomerate, Polyhydroxystearic Acid, Hydroxyacetophenone, Sodium Chlorde, Phenoxyethanol, Propanediol, Panthenol, Tocopheryl Acetate, Oryza Sativa (Rice) Bran Wax, Citric Acid, Bisabolol,, Sodium Hydroxide, Xanthan Gum, Disodium EDTA, Sodium Citrate, Pantolactone, Tocopherol, Ganoderma Lucidum (Mushroom) Extract, Iron Oxides (C.I. 77492), Iron Oxides (C.I. 77491),

Iron Oxides (C.I. 77499)

Other Information

STORAGE AND HANDLING SECTION

Protect this product in this container from excessive heat and direct sun

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ULTRA VIOLETTE

VELVET SCREEN BROAD SPECTRUM SPF 40

BLURRING MINERAL SKINSCREEN

1.7 FL. OZ../ 50 ml

PDPPDP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

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
84803-11584803-115-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-05-27full-release2026-06-01 01:59:09

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
Ultra Violette Velvet Screen Blurring Mineral Skinscreen Broad Spectrum SPF 40ZINC OXIDEGrace and Fire USA Inc.52d4b1c1-7431-4f8c-e063-6294a90ad4822026-06-17WarningsExact identifier
ndc (package): 84803-115-50
ndc (product): 84803-115
ndc11 (package): 84803011550
spl id: 5474d16b-49f3-00f9-e063-6394a90aca99
spl set id: 52d4b1c1-7431-4f8c-e063-6294a90ad482

Reported adverse events (FAERS/openFDA)#

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