Chem-free Active Defense Spf 30
FDA Label NDC 71994-007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Van Laere Llc for the product Chem-free Active Defense Spf 30 (NDC 71994-007). 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 - 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

Distributed by van laere llc, New York, NY10003, USA

Active Ingredient

Zinc Oxide 17.5%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn
  • Retains SPF after 80 minutes of activity in the water or perspiring

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 - Stop Use

Stop use and ask a doctor if 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 Centre right away

Directions

Apply generously 15 minutes before sun exposure.

Reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 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 a 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
      • Children under 6 months of age: Ask a doctor

Other Information

Protect this product from excessive heat and direct sun. Report a serious adverse event reaction to: van laere llc. 119 Fifth Avenue, New York, NY 10003

Inactive Ingredients

Water (Aqua), Isononyl Isononanoate, Caprylic/Capric Triglyceride, Dimethicone, Hexylene Glycol, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Argania Spinosa Kernel Extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copoly Polyglyceryl-4 Isostearate, Tocopheryl Acetate, Polyhydroxystearic Acid, Squalane, Polyglyceryl-3 -Poyricinoleate, Phenoxyethanol, Lecithin, Sodium Chloride, Isostearic Acid, Hexyl Laurate Ethylhexylglycerin, Bisabolol, Caprylyl Glycol, Polysorbate 60, Chlorphenesin, Disodium EDTA

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Chem-Free Active Defense SPF30

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