Tan De Soleil Orange Tanning Balm Spf 6 Oil
FDA Label NDC 84562-509

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tanning Club, Llc for the product Tan De Soleil Orange Tanning Balm Spf 6 (NDC 84562-509). 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, 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 Ingredients

Homosalate 3.00%

Octisalate 4.0%

Purpose

Sunscreen

Uses:

  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • If used as directed with other sun protection measures (see  Directions), decreases the risk of skin cancer and early skin aging 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 or irritation develops and lasts.

Keep Out Of Reach Of Children.

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

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions:

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • 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 aging.  To decrease the risk, regularly use a sunscreen with broad spectrum SPF 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.

Other Information:

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

Inactive Ingredients:

Butyrospermum Parkii (Shea) Butter, Hydrogenated Vegetable Oil, Iron Oxide (CI 77492), Isopropyl Myristate, Mineral Oil, Ozokerite Wax, Paraffin, Parfum (Fragrance), Petrolatum, Theobroma Cacao (Cocoa) Butter), I-Tyrosine, Tocopheryl Acetate (Vitamin E), D&C Red#17.

Questions

(877) TAN-0052 - (877) 826-0052

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