FDA.reportPublic FDA data

SPORT NATURAL MINERAL TINTED SUNSCREEN

Manufacturer
Synchronicity Spa, Inc. DBA Suntegrity
Effective date
2023-07-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:28:02

Label at a glance#

ProductSPORT NATURAL MINERAL TINTED SUNSCREEN
Active ingredientZinc Oxide
Label structure9 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 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 th...

Storage and handling

protect the product in this container from excessive heat and 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 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 10am to 2pm
    • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of age; Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

helianthus annus (sunflower) seed oil1, caprylic/capric triglyceride1, cera alba (beeswax)1, olea europaea (olive) fruit oil1, ricinus communis (castor) seed oil1, simmondsia chinensis (jojoba) oil1, butyrospermum parkii (shea) butter1, tocopherol, mica (ci 77019), iron oxides (ci 77491, ci 77492)

1 certified organic ingredient

Other Information

STORAGE AND HANDLING SECTION

  • protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sun
tegrity®

NATURAL MINERAL
TINTED SUNSCREEN
SPORT

Water Resistant
(80 Minutes)

SPF
30
BROAD SPECTRUM SPF 30
UVA/UVB | Non-Nano Zinc Oxide
NATURAL TINT

NSF
contains organic
ingredientsCM

Unscented
Reef Friendly | Cruelty Free

NET WT 3 OZ (85g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Label
PRINCIPAL DISPLAY PANEL - 85 g Tube 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
69949-21569949-215-01

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
SUNFLOWER OIL3W1JG795YIIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
WHITE WAX7G1J5DA97FIACT
OLIVE OIL6UYK2W1W1EIACT
CASTOR OILD5340Y2I9GIACT
JOJOBA OIL724GKU717MIACT
SHEA BUTTERK49155WL9YIACT
TOCOPHEROLR0ZB2556P8IACT
MICAV8A1AW0880IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT

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
1d226cb5-e8d4-42fc-b356-e061c7aced33efe628ad-115e-49b8-91f6-92e9c19ccb5a2023-07-25WarningsExact identifier
spl id: 1d226cb5-e8d4-42fc-b356-e061c7aced33
spl set id: efe628ad-115e-49b8-91f6-92e9c19ccb5a

Reported adverse events (FAERS/openFDA)#

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