FDA.reportPublic FDA data

Solar SPF 40

Manufacturer
MDSolarSciences
Effective date
2025-06-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:02:24

Label at a glance#

ProductSolar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 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 Reapply: after 80 minutes of swimming or sweating immediately after towel drying 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 the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures...

Storage and handling

Rub in well. Protect the product in this container from excessive heat and direct sunlight May stain some fabrics You may report serious adverse reactions to: Report Reaction LLC PO Box 611, Pompton Plains, NJ 07444

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Titanium Dioxide 8.1%Sunscreen
Zinc Oxide 6%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 useon damaged or broken skin

OTC - STOP USE SECTION

Stop use and ask a doctorif rash occurs

OTC - WHEN USING SECTION

When using this productkeep 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
  • Reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • 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 the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10a.m.-2p.m.
    • Wear long-sleeved shirts, pants, hats and sunglasses

Other Information

STORAGE AND HANDLING SECTION

Rub in well.

  • Protect the product in this container from excessive heat and direct sunlight
  • May stain some fabrics
  • You may report serious adverse reactions to: Report Reaction LLC PO Box 611, Pompton Plains, NJ 07444

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Polyethylene, Dimethicone, Butyloctyl Salicylate, Petrolatum, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Methyl Dihydroabietate, Acrylates/ Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Octyldodecanol, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopherol (Vitamin E), Behenyl Olivate, Aluminum Hydroxide, Stearic Acid, Sorbitan Sesquioleate, Glyceryl Isostearate, Polyhydroxystearic Acid, Citric Acid, Benzylidene Dimethoxydimethylindanone

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
MDSOLARSCIENCES CORP.
GREENS FARMS, CT 06838

PRINCIPAL DISPLAY PANEL - 17 G Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MDSOLARSCIENCES ®

SOLAR STICK™

Broad Spectrum SPF 40
Water Resistant (80 Min)
Mineral Sunscreen

SPF 40

Sheer, lightweight
portable protection

DERMATOLOGIST DEVELOPED
With Vitamins C + E

0.6 OZ / 17 G

PRINCIPAL DISPLAY PANEL - 17 G Tube Carton
PRINCIPAL DISPLAY PANEL - 17 G Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49358-577-012025-06-05C16284748780-12cef2736-b6a3-d83d-e063-dadaa90ab31fSolar Stick™ SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Sunscreen
49358-577-012025-01-30C16284748780-12cef2736-b6a3-d83d-e063-dadaa90ab31fSolar Stick™ SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49358-577-01Solar SPF 40Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen1 in 1 CARTONSTICK12
49358-577-01Solar SPF 40Broad Spectrum SPF 40 Water Resistant (80 min) Mineral Suncreen17 g in 1 TUBESTICK172

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49358-57749358-577-01

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
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
DIMETHICONE92RU3N3Y1OIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PETROLATUM4T6H12BN9UIACT
SHEA BUTTERK49155WL9YIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW)S7ZA3CCJ4MIACT
OCTYLDODECANOL461N1O614YIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
TOCOPHEROLR0ZB2556P8IACT
BEHENYL OLIVATENGS1GGK4GWIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BENZYLIDENE DIMETHOXYDIMETHYLINDANONE75HIF3C97LIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
Solar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences6ce602bb-c1f4-43c1-ae61-0f05d7952db32025-06-05WarningsExact identifier
ndc (package): 49358-577-01
ndc (product): 49358-577
ndc11 (package): 49358057701
spl id: 36d8788d-8533-df6d-e063-6394a90add46
spl set id: 6ce602bb-c1f4-43c1-ae61-0f05d7952db3

Reported adverse events (FAERS/openFDA)#

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