Environmental Defense Cream
FDA Label NDC 58518-010

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Avasol Llc for the product Environmental Defense (NDC 58518-010). 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 - stop use, otc - do not use, 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

Drug Facts

Other information Shake well before use. Warm as needed

Active Ingredients

Zinc Oxide (non-nano) 22.5%

Purpose

Sunscreen

Uses

  • helps prevent sunburn

Warnings

  • For external use only
  • Keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash or irritation occurs.

Otc - Do Not Use

Do not use if allergic to ingredients, or nuts. Test small area first.

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 before sun
  • reapply: after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours, or as needed
  • children under 6 months: Ask a doctor.
  • May stain some fabrics.

Inactive Ingredients

Caprylic/Capric Triglyceride (coconut),*Jojoba Oil, *Sunflower Oil, **Candelilla wax, *Calophyllum Inophyllum (Tamanu) Oil, **Argania spinosa (Argan) Oil, Silica,Theobroma Grandiflorum (Cupuacu) Butter, *Butyrospermum parkii (Shea) Butter, *Mauritia Flexuosa (Buriti) Oil, Emu Oil,*Rubus Idaeus (Raspberry) Seed Oil, *Beeswax, Propolis, Tocopherol, *Fragrance, Mica, Plankton Extract, *Rosemary Extract, Iron Oxides.

*Organic **Wildcrafted

Otc - Questions

Questions? Call 888-805-1507 or visit www.avasol.com

Manufactured in the USA for
AVASOL
1187 Coast Village # 611
Santa Barbara, CA 93108

Principal Display Panel - 2.5Oz Bottle Label

avasol®

natural mineral
sunscreen

30 SPF

2.5 FL OZ (75 ml)

* Please review the disclaimer below.