Broad Spectrum Sunscreen Spf 30
FDA Label NDC 69146-301

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Truth Aesthetics Llc for the product Broad Spectrum Sunscreen Spf 30 (NDC 69146-301). 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 back panel - active ingredient, back panel - purpose, back panel - uses, back panel - directions, back panel - warnings, back panel - inactive ingredients, otc - questions, front panel - pdp, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Back Panel - Active Ingredient

Titanium Dioxide 12.1%

Back Panel - Purpose

Sunscreen

Back Panel - Uses

  • Helps prevent sunburn.
  • 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.

Back Panel - Directions

Directions

  • Apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: Ask a doctor
  • Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a board 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-sleeve shirts, pants, hats, and sunglasses

Back Panel - Warnings

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 doctor

if rash occurs

----------------------------------------------------------

Keep out of reach of children.

If product is swallowed, get medical help or

contact a Poison Control Center right away.

Back Panel - Inactive Ingredients

Inactive Ingredients: Water/Aqua/EAU, Glycerin, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cyclopentasiloxane, coconut Alkanes, Caprylic / Capric Triglycerine, Mica (CI77019), Propanediol, Polyhydroxystearic Acid, Stearoxymethicone / Dimenthicone Copolymer, Stearic Acid, Simmondsia Chinensis (Jojoba) Seed Oil, Diisopropyl Dimer Dilinoleate, Alumina, Caprylyl Caprylate / Caprate, Lauryl Glucoside, Phenethyl Alcohol, Oriza Sativa (Rice) Bran Extract, Pyrus Malus (Apple) Fruit Extract, Coco- Caprylate / Caprate, Cichorium Intybus (Chicory) Root Extract, Carbomer, Helianthus Annuus (Sunflower) Seed Oil, Ethylhexylglycerin, Aminomethyl Propanol, Xanthan Gum, Phenoxyethanol, Silica, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol.

Front Panel - Pdp

TRUFORA

Titanium Day Cream SPF 30

Broad Spectrum Sunscreen

30 ml / 1 fl. oz

* Please review the disclaimer below.