FDA.reportPublic FDA data

ClearSPF Sheer Sunscreen

Manufacturer
Synchronicity Spa, Inc. DBA Suntegrity
Effective date
2024-11-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:48:47

Label at a glance#

ProductClearSPF Sheer 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 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 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 value of 15 or higher and other sun protection measures includi...

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.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact 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 value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10a.m.– 2p.m.

  • Wear long-sleeve shirts, pants, hats, and sunglasses.

Other information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Butyloctyl Salicylate, Coco-Caprylate, Niacinamide, Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Glycerin, Panthenol, Tocopheryl Acetate, Sucrose Palmitate, Glyceryl Stearate, Xanthan Gum, Citric Acid, Saccharide Isomerate, Sucrose Tristearate, Sodium Stearoyl Glutamate, Benzyl Alcohol, Dehydroacetic Acid, Sodium Phytate

Questions?

OTC - QUESTIONS SECTION

888-786-5221

SPL UNCLASSIFIED SECTION

Distributed By: Suntegrity Skincare, Las Vegas, NV 89128

PRINCIPAL DISPLAY PANEL - 48 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLEARSPF

Sheer Moisturizing
Daily Sunscreen
Broad Spectrum SPF 30

SPF
30

20% Non-Nano Zinc Oxide

Niacinamide & Panthenol

Lightweight Formula | For All Skin Tones

Net Wt. 1.7 oz (48 g)

Principal Display Panel - 48 g Bottle Label
Principal Display Panel - 48 g Bottle Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69949-250CLEARSPF SHEER SUNSCREEN (ZINC OXIDE) LOTION [SYNCHRONICITY SPA, INC. DBA SUNTEGRITY]2Unmatched20241124_04bf7fa7-484d-416e-bd41-cd5ce9ddf68f.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
69949-25069949-250-01

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
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
COCO-CAPRYLATE4828G836N6IACT
NIACINAMIDE25X51I8RD4IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
GLYCERINPDC6A3C0OXIACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SUCROSE PALMITATE3OSQ643ZK5IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
SUCROSE TRISTEARATE71I93STU5MIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
BENZYL ALCOHOLLKG8494WBHIACT
DEHYDROACETIC ACID2KAG279R6RIACT
PHYTATE SODIUM88496G1ERLIACT

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
4b948f8d-1c1f-0fa7-e063-6394a90a41c104bf7fa7-484d-416e-bd41-cd5ce9ddf68f2026-02-24WarningsExact identifier
spl set id: 04bf7fa7-484d-416e-bd41-cd5ce9ddf68f

Reported adverse events (FAERS/openFDA)#

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