Octinoxate
FDA Label NDC 60541-8407

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hayden Caleel Llc for the product Octinoxate (NDC 60541-8407). 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 other, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Octinoxate 5%

Titanium Dioxide 10%

Purpose

Sunscreen

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.

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

When using this product keep out of the eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if skin rash occurs.

Otc - Keep Out Of Reach Of Children

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
  • children under 6 months of age: 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 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

Other Information

  • protect this product from excessive heat and direct sun

Inactive Ingredients

Aqua (Water/Eau), Ethylhexyl Palmitate, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Trimellitate, Silica, Cyclopentasiloxane, Caprylic/Capric Triglyceride, HDI/Trimethylol Hexyllactone Crosspolymer, Butylene Glycol, Glycerin, Polyglyceryl-3 Diisostearate, Cyclohexasiloxane, Octyldodecanol, Octyldecyl Xyloside, PEG-30 Dipolyhydroxystearate, Silica Dimethyl Silylate, Phenoxyethanol, Hydroxyethylacrylate/Sodium Acryloydimethyl Taurate Copolymer, Isohexadecane, Polysorbate 60, Caprylyl Glycol, Ethylhexyl Glycerin, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Polymethylsilsesquioxane, Dimethicone, Retinyl Palmitate (Vitamin A), Triethoxycaprylylsilane, Camellia Oleifera (Green Tea) Leaf Extract, Diamond Powder, (+/-):Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

Questions Or Comments?

Call: 1.800.232.0398 M-F 9am-6pm MST

Principal Display Panel - 30 Ml Carton Label

LUXE

LIQUID FOUNDATION

BROAD SPECTRUM SPF 18

ANTI-AGING

DIAMOND POWDER

TECHNOLOGY

glo·minerals

30 mL / 1 fl. oz.

Principal Display Panel (30 mL Carton Label)

Principal Display Panel (30 mL Carton Label)

* Please review the disclaimer below.