TheradermSPF 43 description, usages, side effects, indications, overdosage, supplying and lots more!

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TheradermSPF 43

Therapon Skin Health, LP

Theraderm


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

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

TheradermSPF 43 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 LabelTheradermSPF 43

Theraderm Box LabelTheradermSPF 43

TheradermSPF 43

Zinc Oxide, Octinoxate, Octisalate EMULSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:66428-002
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Zinc Oxide Zinc oxide 7.5 mL
OCTINOXATE OCTINOXATE 7.5 mL
OCTISALATE OCTISALATE 2.5 mL

Inactive Ingredients

Ingredient Name Strength
water
ISOPROPYL PALMITATE
Octyl Stearate
ETHYLHEXYL ISONONANOATE
CYCLOMETHICONE 5
CETEARYL GLUCOSIDE
DIMETHICONE
GLYCERETH-26
HYALURONATE SODIUM
PANTHENOL
ALLANTOIN
OLETH-3 PHOSPHATE
2-HYDROXYETHYL ACRYLATE
Polyisobutylene (1300 MW)
COCONUT ALCOHOL
Polyester-7
Ethylene Oxide
POLYETHYLENE GLYCOL 350
Polyisobutylene (1300 MW)
PHENOXYETHANOL
BUTYLENE GLYCOL
IODOPROPYNYL BUTYLCARBAMATE
.ALPHA.-TOCOPHEROL ACETATE
ASCORBYL PALMITATE
TRIETHOXYCAPRYLYLSILANE

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-01-20


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