DERMA SWISS 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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Derma Swiss SPF 50 Mineral Lotion

Active ingredients

Titanium Dioxide 4 %

Zinc Oxide 4 %

Purpose

Sunscreen

Uses:

Warnings

For external use only

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

Derma Swiss Broad Spectrum SPF 50 SUNSCREEN Mineral Lotion

Principal Display Label

DERMA SWISS  SPF 50 MINERAL
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0362
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE42.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE42.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
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)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
LEVOMENOL (UNII: 24WE03BX2T)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
Colorwhite (White to Off-White) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0362-389 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(58443-0362) , manufacture(58443-0362) , label(58443-0362) , analysis(58443-0362)

Revised: 9/2020
Document Id: afe978b6-082b-46a6-e053-2a95a90ad74a
Set id: afe978b6-082a-46a6-e053-2a95a90ad74a
Version: 1
Effective Time: 20200922
 
Prime Enterprises Inc.