Pure Haven Face Sunscreen Spf-30 Lotion
FDA Label NDC 71355-219

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pure Haven, Llc for the product Pure Haven Face Sunscreen Spf-30 (NDC 71355-219). 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 if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Zinc Oxide (14%)

Purpose

sunscreen

Uses:

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • 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.

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 or irritation develops and lasts.

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.
  • Reapply at least every 2 hours.
  • Reapply as needed or after towel drying, swimming, or sweating.
  • Use a water-resistant sunscreen if swimming or sweating.

    • SUN PROTECTION MEASURES.

    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF 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.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Citric Acid, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Hydrolyzed Jojoba Esters, Lecithin, Polyhydroxystearic Acid, Tocopherol (Vitamin E),Tridecyl Salicylate, Xanthan Gum.

Other Information:

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

Package Labeling:

Label (Label)

Label (Label)

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