DERMASWISS BROAD SPECTRUM SPF 50 MINERAL- titanium dioxide, zinc oxide lotion 
Prime Enterprises Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DermaSwiss DERMASUN Sunscreen Broad Spectrum SPF 50

Active ingredients

Titanium Dioxide 4 %

Zinc Oxide 4 %

Purpose

Sunscreen

Uses:

Warnings

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients:

Allantoin, Aloe Barbadensis Leaf Extract, Alumina, Bisabolol, Butyrospermum Parkii (Shea) Butter, Camellia Oleifera (Green Tea) Leaf Extract, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Dimethicone Crosspolymer, Disodium EDTA, Disteardimonium Hectorite, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Hexyl Laurate, Panthenol, PEG-10 Dimethicone, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane, Silica, Stearic Acid, Tocopheryl Acetate, Water

Other information

Questions or comments?

dermaswiss@dermaswiss.com

DermaSwiss DERMASUN Sunscreen Broad Spectrum SPF 50 - 89 mL

Principle Display Label

DERMASWISS  BROAD SPECTRUM SPF 50 MINERAL
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0422
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE42.36 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE42.36 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PANTHENOL (UNII: WV9CM0O67Z)  
LEVOMENOL (UNII: 24WE03BX2T)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ALLANTOIN (UNII: 344S277G0Z)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
SHEA BUTTER (UNII: K49155WL9Y)  
WATER (UNII: 059QF0KO0R)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
GLYCERIN (UNII: PDC6A3C0OX)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0422-389 mL in 1 TUBE; Type 0: Not a Combination Product11/20/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/20/2019
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0422) , manufacture(58443-0422) , label(58443-0422) , analysis(58443-0422)

Revised: 9/2021
Document Id: cc2174fc-0ede-c11a-e053-2a95a90a6984
Set id: cc2174f3-fa1b-0c42-e053-2995a90a9507
Version: 1
Effective Time: 20210916
 
Prime Enterprises Inc.