Made Of Broad Spectrum Spf 30 Non-nano Zinc Oxide Sunscreen
FDA Label NDC 71439-050

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Madeof, Llc for the product Made Of Broad Spectrum Spf 30 Non-nano Zinc Oxide Sunscreen (NDC 71439-050). 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 ingredient, purpose, uses, warnings, otc - do not use, otc - when using, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Otc - Do Not Use

→ Otc - When Using

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Ingredients

→ Other Information:

→ Principal Display Panel - 118 Ml Tube

Other

Drug Facts

Active Ingredient

Non-Nano Uncoated Zinc Oxide 20.0%

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 eyes. Rinse with water to remove.

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

Diretions for full protection, apply liberally (2mg/cm2) to all exposed skin 15 minutes before sun exposure then rub it in to reduce whitening effect.

Reapply:

After 40 minutes of swimming or sweating • Immediately after towel drying. • At least every two hours.

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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10am-2pm
- Wear long-sleeved shirts, pants, hats, and sunglasses
- For children under six months of age ask a doctor.

Ingredients

Helianthus Annuus* (Sunflower) Oil, Cocos Nucifera* (Coconut) Oil, Cera Alba* (Beeswax), Theobroma Cacao* (Cocoa) Seed Butter, Vanilla Oil* (Vanilla), Tocopherol*, Argania Spinosa Leaf* (Argan) Oil, Rubus Ideaus* (Raspberry) Seed Oil
*=Certified Organic