FDA.reportPublic FDA data

SPORT MINERAL SUN

Manufacturer
Synchronicity Spa, Inc. DBA Suntegrity
Effective date
2023-07-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:27:54

Label at a glance#

ProductSPORT MINERAL SUN
Active ingredientZinc Oxide
Label structure10 sections

Indications and 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

Dosage and administration

apply liberally 15 minutes before sun exposure Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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...

Storage and handling

protect this product from excessive heat & direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (20%)

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 and 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
  • Reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • 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, especially from 10am to 2pm
    • wear long-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months; Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

cocos nucifera (coconut) oil1, helianthus annuus (sunflower) seed oil1, cera alba (beeswax)1, euphorbia cerifera (candelilla wax), copernicia cerifera (carnauba) wax1, butyrospermum parkii (shea) butter1, ricinus communis (castor) seed oil1, tocopherol, theobroma cacao (cocoa) seed butter1, aloe barbadensis leaf juice (aloe vera)1, citrus sinensis (sweet orange) essential oil1

1 certified organic ingredient

Other Information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat & direct sun

SPL UNCLASSIFIED SECTION

Distributed By
Suntegrity Skincare®
Las Vegas, NV 89128

PRINCIPAL DISPLAY PANEL - 33 g Cylinder Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sun
tegrity®

MINERAL SPORT
SUN STICK

WATER RESISTANT
(80 MINUTES)

BROAD SPECTRUM SPF 30

Reef-Friendly
NSF
contains organic
ingredientsCM
Cruelty-Free

NET WT 1.16 OZ (33 g)

PRINCIPAL DISPLAY PANEL - 33 g Cylinder Label
PRINCIPAL DISPLAY PANEL - 33 g Cylinder Label

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69949-20169949-201-01, 69949-201-02, 69949-201-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
COCONUT OILQ9L0O73W7LIACT
SUNFLOWER OIL3W1JG795YIIACT
WHITE WAX7G1J5DA97FIACT
CANDELILLA WAXWL0328HX19IACT
CARNAUBA WAXR12CBM0EIZIACT
SHEA BUTTERK49155WL9YIACT
CASTOR OILD5340Y2I9GIACT
TOCOPHEROLR0ZB2556P8IACT
COCOA BUTTER512OYT1CRRIACT
ALOE VERA LEAFZY81Z83H0XIACT
CITRUS SINENSIS FLOWER OILAJ56JP5TFPIACT

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
b13ccedb-a045-4fcd-a008-907b0876713f5a9036cd-e31b-40e9-8281-8472423e14fc2024-11-21WarningsExact identifier
spl set id: 5a9036cd-e31b-40e9-8281-8472423e14fc

Reported adverse events (FAERS/openFDA)#

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