Theradermspf 43
FDA Label NDC 66428-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Therapon Skin Health, Lp for the product Theradermspf 43 (NDC 66428-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, uses, warnings, directions, inactive ingredients, label for tube and box, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Label (Theraderm Tube)

Label (Theraderm Tube)

Theraderm Box Label

Box (Theraderm Box)

Box (Theraderm Box)

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