Mineral Lip Balm Stick
FDA Label NDC 69949-559

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Synchronicity Spa, Inc. Dba Suntegrity for the product Mineral Lip Balm (NDC 69949-559). 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 - do not use, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Zinc Oxide 8.0%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

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 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 sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months of age: 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 10a.m. – 2p.m.
    • wear long sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

Sunflower Oil, Beeswax, Olive Oil

Organic Ingredient

, Flavor, Tocopherol, Soybean Oil, Aloe Extract, Canola Oil.

Other Information

Protect this product from excessive heat and direct sun.

Storage And Handling

Dist. By: Synchronicity Spa, Inc. DBA: Suntegrity Las Vegas, NV USA, 89128

Principal Display Panel - 4.25 G Tube Label

sun
tegrity®

MINERAL
LIP BALM

PINEAPPLE

BROAD SPECTRUM SPF 15

SPF 15

NON-NANO ZINC OXIDE

Reef-Friendly
Cruelty-Free

Principal Display Panel (4.25 g Tube Label)

Principal Display Panel (4.25 g Tube Label)

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