FDA.reportPublic FDA data

Professional Solutions Suncreen SPF 30

Manufacturer
Cosmetic Solutions LLC
Effective date
2019-09-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:35

Label at a glance#

ProductProfessional Solutions Suncreen SPF 30
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply generously until desired coverage is achieved. If exposed to sun, reapply every 2 hours. If swimming or sweating, use water resistant sunscreen. 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 ...

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 INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7%

Titanium Dioxide 2.5%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

WARNINGS

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove.Stop use and ask a doctor if rash occurs.

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 generously until desired coverage is achieved. If exposed to sun, reapply every 2 hours. If swimming or sweating, use water resistant sunscreen.

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 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Aloe Barbadensis Leaf Extract, Isocetyl Stearate, Sorbitol, Cetearyl Alcohol, Ceteareth-20, Tocopheryl Acetate, Acetyl Hexapeptide-8, Hydrolyzed Rice Protein, Alcohol SDA-40, Dimethicone, Octyl Salicylate, Cetyl Alcohol, Sodium Laureth Sulfate, Carbomer, Camellia Sinensis (Green Tea) Leaf Extract, Fragrance, Triethanolamine, Triethoxycaprylylsilane, Lecithin, Caprylyl Glycol, Methylisothiazolinone.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

Manufactured By:
Professional Solutions
Boca Raton, FL 33487

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Professional
Solutions®
PURE SCIENCE. BETTER SKIN

sunscreen lotion
broad spectrum spf 30
water resistant (40 mins)

protects + moisturizes

2 Fl. Oz. (60mL)

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66163-6500-22021-01-29C16284748780-1ba0f9c33-1ea7-a910-e053-dadaa90a0b85Professional Solutions ® Suncreen SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66163-6500-2Professional Solutions Suncreen SPF 3060 mL in 1 BOTTLE, PLASTICLOTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66163-6500PROFESSIONAL SOLUTIONS SUNCREEN SPF 30 (OCTINOXATE AND TITANIUM DIOXIDE) LOTION [COSMETIC SOLUTIONS LLC]1Legacy NDC, 1 package rows20190926_cb8dfbf0-142f-4579-b906-94c0925522d7.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66163-650066163-6500-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
Water059QF0KO0RIACT
Aloe Vera LeafZY81Z83H0XIACT
Isocetyl Stearate3RJ7186O9WIACT
Sorbitol506T60A25RIACT
Cetostearyl Alcohol2DMT128M1SIACT
Polyoxyl 20 Cetostearyl EtherYRC528SWUYIACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT
Acetyl Hexapeptide-8L4EL31FWILIACT
Dimethicone92RU3N3Y1OIACT
Octisalate4X49Y0596WIACT
Cetyl Alcohol936JST6JCNIACT
Methicone (20 Cst)6777U11MKTIACT
Sodium Laureth-3 SulfateBPV390UAP0IACT
Carboxypolymethylene0A5MM307FCIACT
Green Tea LeafW2ZU1RY8B0IACT
Trolamine9O3K93S3TKIACT
Stearic Acid4ELV7Z65APIACT
TriethoxycaprylylsilaneLDC331P08EIACT
Aluminum OxideLMI26O6933IACT
Caprylyl Glycol00YIU5438UIACT
Methylisothiazolinone229D0E1QFAIACT

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
b79614cf-044e-4c79-8c00-343dbef0b338cb8dfbf0-142f-4579-b906-94c0925522d72019-09-25WarningsExact identifier
spl id: b79614cf-044e-4c79-8c00-343dbef0b338
spl set id: cb8dfbf0-142f-4579-b906-94c0925522d7

Reported adverse events (FAERS/openFDA)#

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