Mineral Sun Drops Lotion
FDA Label NDC 69949-025

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 Sun Drops (NDC 69949-025). 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 - 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

DISTRIBUTED BY:
Synchronicity Spa, Inc.
Las Vegas, NV 89128

Active Ingredient

Zinc Oxide 22%

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

Directions

  • -Shake well before use.
  • -Apply liberally 15 minutes before sun exposure.
  • -Reapply: after 80 minutes of swimming or sweating; immediately after towel drying; 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 skin early 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, expecially from 10am to 2pm – Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

Aloe Barbadensis Leaf Juice and Water, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Propanediol, Jojoba Esters, Methylheptyl Isostearate, Polyglyceryl-10 Stearate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Hydrogenated Methyl Abietate, Caprylol Glycerin/Sebacic Acid Copolymer, Polyglyceryl-2 Dipolyhydroxystearate, Caprylhydroxamic acid (and) Glyceryl Caprylate (and) Glycerin, Tapioca Starch, Sorbitan Sesquioleate, Lecithin, Pongamia Pinnata Seed Extract, Tocopherol, Bisabolol, Sodium Phytate, Allantoin.

Other Information

Protect this product from excessive heat & direct sun

Questions?

Call 888-786-5221

Principal Display Panel - 30 Ml Bottle Box

sun
tegrity®

MINERAL
SUN DROPS

BROAD SPECTRUM SPF 30
SPF 30
NON-NANO ZINC OXIDE

Water Resistant
(80 Minutes)

30 mL ℮ 1 fl oz
Lotion

Principal Display Panel (30 mL Bottle Box)

Principal Display Panel (30 mL Bottle Box)

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