FDA.reportPublic FDA data

Pharmaskincare Solar-C Moisturizer SPF 15

Manufacturer
Spa de Soleil
Effective date
2017-10-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:40

Label at a glance#

ProductPharmaskincare Solar-C Moisturizer SPF 15
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Sun Alert) decreases the risk of skin cancer and early skin aging caused by the sun. Sun Alert: Spending time in the use 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 pro...

Dosage and administration

Apply every morning as a daily moisturizer. Apply generously and evenly 15 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 before use.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 5.3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Warnings

WARNINGS SECTION

  • For external use only.
  • Do not use on broken or damaged skin
  • When using this product, keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor is rash or irritation occurs or lasts.
  • If swallowed, seek medical help or contact a poison control center right away.
  • Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply every morning as a daily moisturizer. Apply generously and evenly 15 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 before use.

Other Information

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat.

Uses:

INDICATIONS & USAGE SECTION

Helps prevent sunburn. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see Sun Alert) decreases the risk of skin cancer and early skin aging caused by the sun.

Sun Alert: Spending time in the use 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 such as limited time in the sun, especially from 10 a.m. to 2 p.m. Wear long pants, hats, sunglasses, and long-sleeve shirts.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Cocos Nucifera (Coconut) Oil, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Caprylic/Capric Triglyceride, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Titanium Dioxide, Polyglyceryl-3 Beeswax, Polyglyceryl-6 Distearate, Jojoba Esters, Polyhydroxystearic Acid, Carbomer, *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, Benzyl Alcohol, Disodium EDTA, Dehydroacetic Acid

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pharmaskincare SolarC SPF 15

Pharmaskincare SolarC SPF 15Pharmaskincare SolarC SPF 15

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68062-9100-12025-01-30C16284748780-12cef2736-a257-d83d-e063-dadaa90ab31fPharmaskincare Solar-C Moisturizer SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68062-9100-1Pharmaskincare Solar-C Moisturizer SPF 1550 mL in 1 JARLOTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68062-9100PHARMASKINCARE SOLAR-C MOISTURIZER SPF 15 (ZINC OXIDE) LOTION [SPA DE SOLEIL]1Legacy NDC, 1 package rows20171011_5b3d3d9c-b1f8-b4e0-e053-2a91aa0afa20.zip

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
68062-910068062-9100-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
COCONUT OILQ9L0O73W7LIACT
SAFFLOWER OIL65UEH262ISIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML · Source PDF

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
5b3d3d9c-b1f9-b4e0-e053-2a91aa0afa205b3d3d9c-b1f8-b4e0-e053-2a91aa0afa202017-10-10WarningsExact identifier
spl id: 5b3d3d9c-b1f9-b4e0-e053-2a91aa0afa20
spl set id: 5b3d3d9c-b1f8-b4e0-e053-2a91aa0afa20

Reported adverse events (FAERS/openFDA)#

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