THERADERMSPF 43 SPF 43- zinc oxide, octinoxate, octisalate emulsion

TheradermSPF 43 by

Drug Labeling and Warnings

TheradermSPF 43 by is a Otc medication manufactured, distributed, or labeled by Therapon Skin Health, LP, Swiss American Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

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

Uses

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

Warnings

• For External use only.
  
• When using, avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  
• Stop use and contact a doctor if irritation or rash develops.
• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• Apply generously 15 minutes before sun exposure.
  
• Reapply to dry skin as needed.
  
• May be applied before make-up

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 Label

Theraderm Box Label

INGREDIENTS AND APPEARANCE

THERADERMSPF 43   SPF 43
zinc oxide, octinoxate, octisalate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66428-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	7.5 mL  in 100 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 mL  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	2.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66428-002-02	1 in 1 BOX
1		90 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/20/2012

Labeler - Therapon Skin Health, LP (792518995)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss American Products, Inc.		611921669	manufacture