MINERAL SUNSCREEN SPF 50 lotion

MINERAL SUNSCREEN SPF 50 by

Drug Labeling and Warnings

MINERAL SUNSCREEN SPF 50 by is a Otc medication manufactured, distributed, or labeled by Volans Epic LLC, PONTIKA AEROTECH LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

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

Niacinamide & Vitamin E
Suitable For Sensitive Skin

Active Ingredients  Purpose

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

Use

For Sun protection

Warnings

FOR EXTERNAL USEONLY.

When using this product

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

KEEP OUT OF REACH OF CHILDREN

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

Directions

Apply sunscreen evenly, 15 minutes before stepping out.

Other lnformation

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

Inactive lngredlents

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?

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

INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN SPF 50 
mineral sunscreen spf 50 lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83325-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.1 g  in 88 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL ACETATE	0.5 g  in 88 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.1 g  in 88 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.1 g  in 88 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
OCTOCRYLENE (UNII: 5A68WGF6WM)
BISOCTRIZOLE (UNII: 8NT850T0YS)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
XANTHAN GUM (UNII: TTV12P4NEE)
BEMOTRIZINOL (UNII: PWZ1720CBH)
OCTISALATE (UNII: 4X49Y0596W)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FRAGRANCE 13576 (UNII: 5EM498GW35)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83325-008-03	88 g in 1 BOTTLE; Type 0: Not a Combination Product	02/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/02/2024

Labeler - Volans Epic LLC (118944905)

Establishment
Name	Address	ID/FEI	Business Operations
PONTIKA AEROTECH LIMITED		861299010	analysis(83325-008) , manufacture(83325-008)