FDA.reportPublic FDA data

NATURAL MINERAL BODY SUNSCREEN

Manufacturer
Synchronicity Spa, Inc. DBA Suntegrity
Effective date
2024-11-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:38:56

Label at a glance#

ProductNATURAL MINERAL BODY SUNSCREEN
Active ingredientZinc Oxide
Label structure11 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases risk of skin cancer and 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 skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including: li...

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 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 product is 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 skin 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 10 a.m. – 2 p.m.
    • wear long sleeved shirts, pants, hats and sunglasses

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera) Leaf Juice1, Capric/Caprylic Triglyceride2, Water (Aqua), Glycerin2, Hydrogenated Castor Oil2, Sorbitan Sesquioleate2, Magnesium Sulfate2, Polyglyceryl-10 Laurate2, Simmondsia Chinensis (Jojoba) Seed Oil1, Helianthus Annuus (Sunflower) Seed Oil1, Cucumis Sativus (Cucumber) Fruit Extract1, Hyaluronic Acid2, Camellia Sinensis (Green Tea) Extract1, Punica Granatum (Pomegranate) Seed Oil1, Dimethicone, Citrus Sinensis (Sweet Orange) Essential Oil1, Citrus Reticulata Blanco (Tangerine) Essential Oil1, Polyaminopropyl Biguanide, Ethylhexylglycerin

1 Certified Organic

2 Natural or Naturally-derived ingredients

Other Information

STORAGE AND HANDLING SECTION

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

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-786-5221 M-F, 10:00am-4:00pm PST.

SPL UNCLASSIFIED SECTION

Distributed By: Suntegrity® Skincare, Las Vegas, NV 89128

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sun
tegrity®

NATURAL MINERAL
BODY
SUNSCREEN
WITH ANTIOXIDANTS

BROAD SPECTRUM SPF 30

SPF 30

NON-NANO ZINC OXIDE

"Suntegrity® was made in honor of my
Mom and all of those who lost their
lives to skin cancer. May you wear this
sunscreen and smile in their memory."

Tricia T.

LIGHT ORANGE SCENT

For Daily Use | All Skin Types

Vegan | Reef Friendly

NET WT 3 OZ (85 g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Label
PRINCIPAL DISPLAY PANEL - 85 g Tube Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69949-100-01NATURAL MINERAL BODY SUNSCREEN85 g in 1 TUBECREAM852
69949-100-02NATURAL MINERAL BODY SUNSCREEN141.7 g in 1 TUBECREAM141.72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69949-100NATURAL MINERAL BODY SUNSCREEN (ZINC OXIDE) CREAM [SYNCHRONICITY SPA, INC. DBA SUNTEGRITY]2Current NDC, Legacy NDC, 2 package rows20241124_dc5116d4-3a42-44d4-b41a-e88b5b16d111.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69949-10069949-100-01, 69949-100-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
POLYGLYCERYL-10 LAURATEMPJ2Q8WI8GIACT
JOJOBA OIL724GKU717MIACT
SUNFLOWER OIL3W1JG795YIIACT
CUCUMBERYY7C30VXJTIACT
HYALURONIC ACIDS270N0TRQYIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
POMEGRANATE SEED OIL0UI45XV0T6IACT
DIMETHICONE92RU3N3Y1OIACT
ORANGE OIL, COLD PRESSEDAKN3KSD11BIACT
MANDARIN OILNJO720F72RIACT
POLYAMINOPROPYL BIGUANIDEDT9D8Z79ETIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
NATURAL MINERAL BODY SUNSCREENZINC OXIDESynchronicity Spa, Inc. DBA Suntegritydc5116d4-3a42-44d4-b41a-e88b5b16d1112024-11-21WarningsExact identifier
ndc (package): 69949-100-01
ndc (package): 69949-100-02
ndc (product): 69949-100
ndc11 (package): 69949010002
ndc11 (package): 69949010001
spl id: 63ef5062-4f1d-4f7a-b1a2-88814db88ca3
spl set id: dc5116d4-3a42-44d4-b41a-e88b5b16d111

Reported adverse events (FAERS/openFDA)#

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