FDA.reportPublic FDA data

Mineral Tinted Sunscreen

Manufacturer
MDSolarSciences
Effective date
2019-08-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:25

Label at a glance#

ProductMineral Tinted Sunscreen Broad Spectrum SPF 30 Sunscreen UVA-UVB 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

Protect the product in this container from excessive heat and direct sunlight You may report serious adverse reactions to: Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Titanium Dioxide 8.25%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 use on damaged or broken skin

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash occurs

OTC - WHEN USING SECTION

When using this product keep 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

  • Protect the product in this container from excessive heat and direct sunlight
  • You may report serious adverse reactions to: Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Polyethylene, Dimethicone, Butyrospermum Parkii (Shea) Butter, Petrolatum, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Undecylcrylene Dimethicone, Neopentyl Glycol Diheptanoate, Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Behenyl Olivate, Aluminum Hydroxide, Stearic Acid, Glyceryl Isostearate, Beeswax, Polyhydro- xystearic Acid, Cetyl PEG/PPG10/1 Dimeth- icone, BHT, Octyldodec- anol, Iron Oxides, Sorbitan Oleate, Citric Acid Benzylidene Dimethoxydimethylindanone, Tetrahexyldecyl Ascorbate

SPL UNCLASSIFIED SECTION

Distributed by:
MDSolarSciences Corp.
Stamford, CT 06902

PRINCIPAL DISPLAY PANEL - 17 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MDSolarSciences™

30

MINERAL
TINTED
SUNSCREEN STICK

BROAD SPECTRUM
SPF 30
UVA-UVB SUNSCREEN

+R
enhanced with
ProVention-R™
antioxidant complex

Dermatologists developed,
approved & recommended

Water resistant (80 minutes)
Non-Comedogenic – Won't clog pores
Oil-Free – Fragrance-Free

sun care

Net Wt. 17g -0.6Oz

PRINCIPAL DISPLAY PANEL - 17 g Tube Carton
PRINCIPAL DISPLAY PANEL - 17 g Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49358-563-012023-01-30C16284748780-1f386c64a-1e16-0266-e053-dadaa90a7c1aMineral Tinted Sunscreen Stick Broad Spectrum SPF 30 Sunscreen UVA-UVB Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49358-563-01Mineral Tinted Sunscreen Broad Spectrum SPF 30 Sunscreen UVA-UVB Suncreen17 g in 1 TUBESTICK171
49358-563-01Mineral Tinted Sunscreen Broad Spectrum SPF 30 Sunscreen UVA-UVB Suncreen1 in 1 CARTONSTICK11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49358-563MINERAL TINTED SUNSCREEN BROAD SPECTRUM SPF 30 SUNSCREEN UVA-UVB SUNCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) STICK [MDSOLARSCIENCES]1Legacy NDC, 2 package rows20190916_05400f51-6c23-40d9-9e9c-dc3f6bfb6da0.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
49358-56349358-563-01

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
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
Dimethicone92RU3N3Y1OIACT
SHEA BUTTERK49155WL9YIACT
PETROLATUM4T6H12BN9UIACT
BUTYLOCTYL OLEATE2830Y2FNR6IACT
SALICYLIC ACIDO414PZ4LPZIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
BEHENYL OLIVATENGS1GGK4GWIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
YELLOW WAX2ZA36H0S2VIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
BENZYLIDENE DIMETHOXYDIMETHYLINDANONE75HIF3C97LIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT

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
04802a76-f6cb-4050-bb7d-b93e3fab9ad405400f51-6c23-40d9-9e9c-dc3f6bfb6da02019-08-05WarningsExact identifier
spl id: 04802a76-f6cb-4050-bb7d-b93e3fab9ad4
spl set id: 05400f51-6c23-40d9-9e9c-dc3f6bfb6da0

Reported adverse events (FAERS/openFDA)#

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