FDA.reportPublic FDA data

MINERAL SUNSCREEN SPF 50

Manufacturer
Volans Epic LLC | PONTIKA AEROTECH LIMITED
Effective date
2024-02-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:25

Label at a glance#

ProductMINERAL SUNSCREEN SPF 50
Active ingredientNIACINAMIDE, .ALPHA.-TOCOPHEROL ACETATE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure12 sections

Dosage and administration

Apply sunscreen evenly, 15 minutes before stepping out.

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

No White Cast
UVA/UVB Protection With PA++++
Weightless & Non-Greasy

Niacinamide & Vitamin E
Suitable For Sensitive Skin

Active Ingredients  Purpose

OTC - ACTIVE INGREDIENT SECTION

Niacinamide 0.01%, Vitamin E Acetate 0.50%, Titanium Di Oxide 0.01%, Zinc Oxide 0.01% ................. Sun protection

Use

OTC - PURPOSE SECTION

For Sun protection

Warnings

WARNINGS SECTION

FOR EXTERNAL USEONLY.

When using this product

OTC - WHEN USING SECTION

■ Avoid contact with eyes. If contact occurs, flush thoroughly with water

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach or children.If swallowed, get medical help. Patch Test Recommended.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply sunscreen evenly, 15 minutes before stepping out.

Other lnformation

SPL UNCLASSIFIED SECTION

Store in a cool & dry place. Keep away from direct sunlight.

Inactive lngredlents

INACTIVE INGREDIENT SECTION

Aqua, Octocrylene, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (and) Aqua (and) Decyl Glucoslde (and) Propylene Glycol (and) Xanthan Gum, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Ethylhexyl Salicylate, Cetyl Alcohol, PEG 100 Stearate & Glyceryl Stearate, C12-15 Alkyl Benzoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glycerin, Phenoxyethanol, Fragrance.

Questions or Comments?

OTC - QUESTIONS SECTION

For any customer feedback or queries, write to us at: info@majesticpure.com or call us on +1 530-464-6426

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY & DOMESTIC REPRESENTATIVE ADDRESS:
Volans Epic LLC
Corporation Trust Center, 1209 Orange Street, Wilmington,
Delaware 19801, Country of New Castle

MANUFACTURED BY:
Pontika Aerotech Limited
Village Johron, PO Puruwala, Nahan Road, Paonta Sahib District
Sirmour, Himachal Pradesh-173001, India

Mfg.Lic.No.:N-COS/18/47

Made in India

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83325-008-03MINERAL SUNSCREEN SPF 5088 g in 1 BOTTLELOTION881

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83325-008MINERAL SUNSCREEN SPF 50 LOTION [VOLANS EPIC LLC]11 package rows20240208_92a8573a-a3c2-4cab-be68-57f8fe0d6c3c.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83325-00883325-008-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
OCTOCRYLENE5A68WGF6WMIACT
BISOCTRIZOLE8NT850T0YSIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
XANTHAN GUMTTV12P4NEEIACT
BEMOTRIZINOLPWZ1720CBHIACT
OCTISALATE4X49Y0596WIACT
CETYL ALCOHOL936JST6JCNIACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
FRAGRANCE 135765EM498GW35IACT
NIACINAMIDE25X51I8RD4ACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
10c9e47e-6996-5841-e063-6394a90a7e8092a8573a-a3c2-4cab-be68-57f8fe0d6c3c2024-02-07WarningsExact identifier
spl id: 10c9e47e-6996-5841-e063-6394a90a7e80
spl set id: 92a8573a-a3c2-4cab-be68-57f8fe0d6c3c

Reported adverse events (FAERS/openFDA)#

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