THERADERMSPF 43  SPF 43- zinc oxide, octinoxate, octisalate emulsion 
Therapon Skin Health, LP

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.



Active Ingredients

Zinc Oxide 7.50% ...................Sunscreen
Octinoxate 7.50% ...................Sunscreen
Octisalate 2.50% ...................Sunscreen


Helps prevent sunburn and photo damage caused by UVA/UVB exposure.



Best used within 12 months of opening.

Inactive Ingredients

Purified water, Isopropyl palmitate, Octyl stearate, Ethyl hexyl isononanoate,Cyclopentasiloxane, Cetearyl glucoside, Dimethicone, Glycereth-26, Sodium Hyaluronate, Panthenol, Allantoin, Oleth-3 phosphate, Hydroxyethyl Acrylate/Sodium acryloyl dimethyl taurate copolymer, Polyisobutene, PEG-7 trimethylolpropane coconut ether, Polyether-1, Phenoxyethanol, Butylene glycol, Iodopropynyl butylcarbamate, Tocopheryl acetate, Triethoxycaprylylsilane.

Label for Tube and Box

Theraderm Tube LabelLabel

Theraderm Box LabelBox

zinc oxide, octinoxate, octisalate emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66428-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide7.5 mL  in 100 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 mL  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate2.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
Octyl Stearate (UNII: 772Y4UFC8B)  
Ethylhexyl Isononanoate (UNII: I6KB4GE3K4)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Cetearyl Glucoside (UNII: 09FUA47KNA)  
Dimethicone (UNII: 92RU3N3Y1O)  
Glycereth-26 (UNII: NNE56F2N14)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Panthenol (UNII: WV9CM0O67Z)  
Allantoin (UNII: 344S277G0Z)  
Oleth-3 Phosphate (UNII: 8Q0Z18J1VL)  
2-Hydroxyethyl Acrylate (UNII: 25GT92NY0C)  
Polyisobutylene (1300 MW) (UNII: 241BN7J12Y)  
Coconut Alcohol (UNII: 13F4MW8Y9K)  
Polyester-7 (UNII: 0841698D2F)  
Ethylene Oxide (UNII: JJH7GNN18P)  
Polyethylene Glycol 350 (UNII: ZBR3T82M2V)  
Polyisobutylene (1300 MW) (UNII: 241BN7J12Y)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Ascorbyl Palmitate (UNII: QN83US2B0N)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66428-002-021 in 1 BOX
190 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/20/2012
Labeler - Therapon Skin Health, LP (792518995)
NameAddressID/FEIBusiness Operations
Swiss American Products, Inc.611921669manufacture

Revised: 1/2012
Document Id: a9bbadd5-6e2d-4221-b508-a9719779b3ce
Set id: d83f0f88-8112-47dc-9bc5-c56f86dec51a
Version: 2
Effective Time: 20120120
Therapon Skin Health, LP