Skin Apeel Ageless Defense Spf 40 Broad Spectrum Cream
FDA Label NDC 83628-208

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Skin Apeel, Inc. for the product Skin Apeel Ageless Defense Spf 40 Broad Spectrum (NDC 83628-208). 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 active ingredients:, purpose:, uses:, warnings:, otc - do not use, otc - stop 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

Active Ingredients:

Zinc Oxide 16%

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 - Stop Use

Stop use and ask a doctor if rash occurs.

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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant product if swimming or sweating.
  • Reapply at least every 2 hours
  • Children under 6 months: 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 am-2 pm
    • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydrogen Dimethicone, Iron Oxide, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

Other Information:

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics

    • Made in USA for Skin Apeel Day Spa | Boca Raton, Florida 33433

Principal Display Panel – 50 G Bottle Label

skin apeel

organic results • cruelty free

Ageless Defense

SPF 40 Broad Spectrum

lightly tinted
ceramides . zinc oxide
antioxidants c + e

Net Wt. 1.75 oz/50 g

Principal Display Panel – 50 G Bottle Label (Ski11 0000 01)

Principal Display Panel – 50 G Bottle Label (Ski11 0000 01)

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