FDA.reportPublic FDA data

PRESSED MINERAL

Manufacturer
Synchronicity Spa, Inc. DBA Suntegrity
Effective date
2022-06-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:58:46

Label at a glance#

ProductPRESSED MINERAL
Active ingredientZinc Oxide
Label structure11 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer & early skin aging caused by the sun

Dosage and administration

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: Ask a doctor Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including: limit ...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 25%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & early skin aging caused by the sun

Warnings

WARNINGS SECTION

  • For external use only

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs

OTC - WHEN USING SECTION

  • When using this product keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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: Ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Mica (CI 77019), Silica, Octyldodecyl Stearoyl Stearate. May Contain: Iron Oxides (CI 77491, CI 77492, CI 77499).

Other Information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-786-5221 M-F10:00am-4:00pm PST.

SPL UNCLASSIFIED SECTION

Distributed By:
Suntegrity® Skincare
Las Vegas, NV 89128

PRINCIPAL DISPLAY PANEL - 14.5 g Compact Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sun
tegrity®

PRESSED
MINERAL POWDER COMPACT

NON-NANO ZINC OXIDE

SPF
50

BROAD SPECTRUM SPF 50

NET WT. 0.51 OZ (14.5g)

Principal Display Panel - 14.5 g Compact Box
Principal Display Panel - 14.5 g Compact Box

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69949-34069949-340-01, 69949-340-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
MICAV8A1AW0880IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
OCTYLDODECYL STEAROYL STEARATE3D47Q6D93CIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
17caa210-1d22-4859-8f03-bc3cf637cd9046b66c1f-b59e-406b-8abd-0763bb17548c2022-06-20WarningsExact identifier
spl id: 17caa210-1d22-4859-8f03-bc3cf637cd90
spl set id: 46b66c1f-b59e-406b-8abd-0763bb17548c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.