FDA.reportPublic FDA data

NATURAL MOISTURIZING FACE SUNSCREEN and PRIMER

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 00:38:55

Label at a glance#

ProductNATURAL MOISTURIZING FACE SUNSCREEN and PRIMER
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 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 childern 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 ti...

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 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
  • Do not use on damaged or broken skin
  • Stop use and ask a doctor if rash occurs
  • 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
  • childern 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

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, Astaxanthin2, Hyaluronic Acid2, Chlorella Emersonii (Red Algae) Extract2, 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 this product 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 - 50 g Canister Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sun
tegrity®

NATURAL MOISTURIZING
FACE SUNSCREEN & PRIMER

BROAD SPECTRUM SPF30

"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.

NET WT. 1.7 OZ (50 g)

Principal Display Panel - 50 g Canister Label
Principal Display Panel - 50 g Canister Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69949-010-01NATURAL MOISTURIZING FACE SUNSCREEN and PRIMER50 g in 1 CANISTERCREAM502
69949-010-02NATURAL MOISTURIZING FACE SUNSCREEN and PRIMER50 g in 1 BOXCREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69949-010NATURAL MOISTURIZING FACE SUNSCREEN AND PRIMER (ZINC OXIDE) CREAM [SYNCHRONICITY SPA, INC. DBA SUNTEGRITY]2Current NDC, Legacy NDC, 2 package rows20241124_5996f9b2-18c1-4c8f-a0ab-eca180db61ad.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69949-01069949-010-01, 69949-010-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 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
ASTAXANTHIN8XPW32PR7IIACT
HYALURONIC ACIDS270N0TRQYIACT
CHLORELLA EMERSONII6701V9L3PVIACT
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 MOISTURIZING FACE SUNSCREEN and PRIMERZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity5996f9b2-18c1-4c8f-a0ab-eca180db61ad2024-11-21WarningsExact identifier
ndc (package): 69949-010-01
ndc (package): 69949-010-02
ndc (product): 69949-010
ndc11 (package): 69949001002
ndc11 (package): 69949001001
spl id: 3dc666fa-dd86-4924-9b90-50d240203981
spl set id: 5996f9b2-18c1-4c8f-a0ab-eca180db61ad

Reported adverse events (FAERS/openFDA)#

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