Rationale The Discovery Travel Kit
FDA Label NDC 83108-210

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rationale Group Pty Ltd for the product Rationale The Discovery Travel Kit (NDC 83108-210). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Zinc Oxide 24.50%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn
  • If used as directed with other other sun protection measures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun

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 swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Apply liberally 15 minutes before sun exposure.
  • Reapply
  • At least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating. 
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m.- 2 p.m.
  • Wear long sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months of age:Ask a doctor

Other Information

  • Protect the product in this container from exceesive heat and direct sun.

Inactive Ingredients

Undecane, Caprylic/Capric Triglyceride, Tridecane, Aqua (Water), Butyloctyl Salicylate, Lauryl PEG-IO Tris(Trimethylsi- loxy)silylethyl Dimethicone, Coco-Caprylate/• Caprate, Polyhydroxystearic Acid, Boron Nitride, Capryloyl Glycerin/Sebacic Acid Copolymer, Ethylhexyl Methoxycrylene, Helianthus Annuus (Sunflower) Seed Oil, Dimethicone, Methyl Methacrylate Crosspolymer, Sodium Potassium Aluminum Silicate, Pentylene Glycol, Silica, Propanediol, 7-Dehydrocholesterol, Bisabolol, Sodium Chloride, Polyurethane-79, Maltodextrin, Cetearyl Dimethicone Crosspolymer, Mica, Copernicia Cerifera (Carnauba) Wax, I ,2•HexanedioI, Fragrance/Parfum, Pongamol, C12-15 Alkyl Benzoate, Calcium Silicate, Voandzeia Subterranea Seed Extract, Glycerin, Lupinus Albus Seed Extract, Caprylhydroxamic Acid Disodium EDTA, Melanin, Tin Oxide,Phenoxyethanol, Lecithin, Triethoxycapry- lylsilane, Plankton Extract, Micrococcus Lysate, Arabidopsis Thaliana Extract, Octyldodecanol, Pelargonium Graveolens Flower Oil, PolyglyceryI•6 Polyricinoleate, Tocopherol, Ethylhexylglycerin, Dilinoleic Acid/ButanedioI Copolymer, Disodium Stearoyl Glutamate, Castor Oil/IPDI Copolymer, Sodium Hyaluronate, Sorbitan Oleate, Acetyl Tetrapeptide-22, Limonene, Citrus Aurantium Peel Oil, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Linalyl Acetate, Vanillin, Linalool, Pinene, Lavandula OiVExtract, Citronellol, CI 77891 (Titanium Dioxide), CI 77492 (Iron Oxides), Cl 77491 (Iron Oxides), Cl 77499 (Iron Oxides), Cl 42090 (Blue 1 Lake).

Package Labeling:

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