FDA.reportPublic FDA data

Moisturizer Sunscreen SPF 50

Manufacturer
Spa de Soleil
Effective date
2026-04-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:55:47

Label at a glance#

ProductMoisture Sunscreen SPF 50
Active ingredientZINC OXIDE, OCTINOXATE
Label structure8 sections

Dosage and administration

Directions: Apply generously and evenly thirty minutes before sun exposure. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating. Children under six months of age: Consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 9.5%

Octinoxate 7.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Warnings

WARNINGS SECTION

Warnings When using this product

  • keep out of the eye area
  • rinse with water to remove
  • stop use and ask a doctor if rash or irritation develops
  • for external use onlyl
  • keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Apply generously and evenly thirty minutes before sun exposure. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating.

Children under six months of age: Consult a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Cocos Nucifera (Coconut) Oil, Carthamus Tinctorius (Safflower) Seed Oil, Heptyl Undecylenate, Caprylic/Capric Triglyceride, Cetyl Alcohol, Glycerin, Polyglyceryl-6 Distearate, Glyceryl Stearate, Titanium Dioxide, PEG-100 Stearate, Jojoba Esters, Polyhydroxystearic Acid, Polyglyceryl-3 Beeswax, Disodium EDTA, *CO Glycerin, Sodium Hydroxide, Thymus Vulgaris (Thyme) Leaf Extract, Rosa Canina Fruit Extract, Gardenia Florida Fruit Extract, Fucus Vesiculosus Extract, *CO Carum Petroselinum (Parsley) Extract, *CO Centella Asiatica Leaf Extract, *CO Cucumis Sativus (Cucumber) Seed Extract, *CO Daucus Carota Sativa (Carrot) Root Extract, *CO Euphrasia Officinalis Extract, Ascorbic Acid (Vitamin C),

INDICATIONS & USAGE SECTION

Directions: Apply generously and evenly thirty minutes before sun exposure. Reapply at least every two hours. Use a water-resistant sunscreen if swimming or sweating.

Children under six months of age: Consult a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF50privateLabel_NDCback.jpgSPF50privateLabel_NDCback.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68062-9001-12023-01-30C16284748780-1f386c64a-0932-0266-e053-dadaa90a7c1aMoisturizer Sunscreen SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68062-9001-1Moisture Sunscreen SPF 50120 mL in 1 TUBELOTION1202

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68062-900168062-9001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
HEPTYL UNDECYLENATEW77QUB6GXOIACT
SAFFLOWER OIL65UEH262ISIACT
GLYCERINPDC6A3C0OXIACT
COCONUT OILQ9L0O73W7LIACT
ZINC OXIDESOI2LOH54ZACTIB
OCTINOXATE4Y5P7MUD51ACTIB

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
Moisture Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilcb95975f-060d-23c2-e053-2a95a90adf1b2026-04-30WarningsExact identifier
ndc (package): 68062-9001-1
ndc (product): 68062-9001
ndc11 (package): 68062900101
spl id: 50b709f4-020b-4c97-e063-6294a90af7c8
spl set id: cb95975f-060d-23c2-e053-2a95a90adf1b

Reported adverse events (FAERS/openFDA)#

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