Lucin Organics Tinted Sunscreen Spf 30 Non Nano Zinc Oxide Cream
FDA Label NDC 84124-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lucin Organics, Llc for the product Lucin Organics Tinted Sunscreen Spf 30 Non Nano Zinc Oxide (NDC 84124-000). 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredients

Zinc Oxide (Non-Nano) 14%

Purpose

Sunscreen

Uses

  • 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. • 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 • reapply at least every 2 hours • use a water-resistant sunscreen if swimming or sweating

Inactive Ingredients

Aqua (Distilled Water), Organic Olive Squalane, Shea Butter Ethyl Esters, Simmondsia Chinensis (Jojoba) Esters, Organic Vitis Vinifera (Grape) Seed Oil, Organic Simmondsia Chinensis (Jojoba) Seed Oil, Silica, Polyglyceryl-4 Olivate/Polyricinoleate, Lactobacillus Ferment, Sorbitan Olivate, Lactobacillus, Cocos Nucifera (Coconut) Fruit Extract, Magnesium Sulfate, Organic Rosmarinus Officinalis (Rosemary) Leaf Extract, Organic Tocopherol (Vitamin E), Lavandula Angustifolia (Lavender) Oil, Cananga Odorata (Ylang Ylang) Oil, Pelargonium Graveolens (Geranium) Oil. May Contain (±): CI 77491, CI 77492, CI 77499 (Iron Oxides), CI 77891 (Titanium Dioxide). Citronellol**, Geraniol**, Linalool**

*Cerified Oraganic Ingredients

** Components of 100% pure essential oils

Other Information

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

Package Labeling:

Label1 (Label1)

Label1 (Label1)

* Please review the disclaimer below.