In Transit Skin Defence Cream
FDA Label NDC 71278-006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by This Works Products Limited for the product In Transit Skin Defence (NDC 71278-006). 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 ingredients, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Avobenzone 3%

Octinoxate 7%

Octocrylene 9.5%

Oxybenzone 6%

Purpose

Sunscreen

Use

  • Helps prevent sunburn.

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.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • 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 10am to2pm.
  • 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 excessive heat and direct sun.

Inactive Ingredients

Aqua (Water/Eau), Butyrospermum parkii (Shea) butter, Acacia decurrens/Jojoba/Sunflower seed cera (Wax/Cire)/Polyglyceryl-3 esters, Glycerin, Butylene glycol, Octyldodecanol, Tapioca starch, Phenoxyethanol, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Glyceryl stearate SE, Stearic acid, Xylitylglucoside, Benzyl alcohol, Sodium stearoyl glutamate, Anhydroxylitol, Polyacrylamide, Xanthan gum, Echium plantagineum seed oil, Lecithin, Xylitol, C13-14 Isoparaffin, Disodium EDTA, Sodium hyaluronate, Theobroma cacao (Cocoa) seed butter, Tocopheryl acetate, Helianthus annuus (Sunflower) seed oil unsaponifiables, Polymethylsilsesquioxane, Dehydroacetic acid, Parfum (Fragrance), Laureth-7, Limonene, Ethylbisiminomethylguaiacol manganese chloride, Cardiospermum halicacabum flower/Leaf/Vine extract, Linalool, Tocopherol, Citrus aurantium amara (Bitter Orange) leaf/Twig oil, Citrus aurantium bergamia (Bergamot) peel oil, Citrus limon (Lemon) peel oil, juniperus virginiana (Cedarwood) wood oil, Citric acid.
*Naturally occuring i essential oils.

Package Labeling:

Box (Box)

Box (Box)

* Please review the disclaimer below.