Label: MINERAL SUNSCREEN SPF 50 lotion
- NDC Code(s): 83325-008-03
- Packager: Volans Epic LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 7, 2024
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- INDICATIONS & USAGE
- Active Ingredients Purpose
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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.
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SPL UNCLASSIFIED SECTION
DISTRIBUTED BY & DOMESTIC REPRESENTATIVE ADDRESS:
Volans Epic LLC
Corporation Trust Center, 1209 Orange Street, Wilmington,
Delaware 19801, Country of New CastleMANUFACTURED BY:
Pontika Aerotech Limited
Village Johron, PO Puruwala, Nahan Road, Paonta Sahib District
Sirmour, Himachal Pradesh-173001, IndiaMfg.Lic.No.:N-COS/18/47
Made in India
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INGREDIENTS AND APPEARANCE
MINERAL SUNSCREEN SPF 50
mineral sunscreen spf 50 lotionProduct 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)
