MDSolarSciences

Manufacturer
MD Solar Sciences
Effective date
2012-04-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:46:50

Label at a glance#

ProductMDSolarSciences Natural Mineral Sunscreen
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure8 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

Storage and handling

Protect the product in this container from excessive heat and direct sunlight May stain some fabrics You may report a 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 ingredients:Purpose
Titanium Dioxide 8.1%Sunscreen
Zinc Oxide 6.6%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 - STOP USE 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.

Other information

STORAGE AND HANDLING SECTION

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

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

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, POLYHYDROXYSTEARIC ACID, CETYL PEG/PPG-10/1 DIMETHICONE, BHT BENZYLIDENE DIMETHOXY-DIMETHYLINDANONE

PRINCIPAL DISPLAY PANEL - 12 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MDSolarSciences

SPF 41
Broad Spectum
UVA-UVB Protection

natural mineral
Sunscreen
KidStick

FOR LIPS, FACE & HANDS
Water Resistant (80 min)

Naturally Derived Mineral Actives
Gentle, Fragrance Free, Easy Application

Safe for Sensitive Skin
FEEL THE DIFFERENCE

For Children 6 Months and Older
DEVELOPED BY DERMATOLOGISTS

Net Weight 12g - .42 oz.

Principal Display Panel - 12 g Tube Carton
Principal Display Panel - 12 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49358-545-012023-08-31C16284748780-197449f38-d4ea-f6ea-e053-dbdaa90aa703Natural Mineral Sunscreen Kid Stick
49358-545-012019-11-13C16284748780-197449f38-d4ea-f6ea-e053-dbdaa90aa703Natural Mineral Sunscreen Kid Stick

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
Titanium DioxideACTIVE MOIETY15FIX9V2JP1
Zinc OxideACTIVE MOIETYSOI2LOH54Z1
Alkyl (C12-15) BenzoateINACTIVE INGREDIENTA9EJ3J61HQ1
Aluminum HydroxideINACTIVE INGREDIENT5QB0T2IUN01
Benzylidene DimethoxydimethylindanoneINACTIVE INGREDIENT75HIF3C97L1
Butylated HydroxytolueneINACTIVE INGREDIENT1P9D0Z171K1
Butyloctyl SalicylateINACTIVE INGREDIENT2EH13UN8D31
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
Glyceryl IsostearateINACTIVE INGREDIENTHYE7O27HAO1
High Density PolyethyleneINACTIVE INGREDIENTUG00KM4WR71
Neopentyl Glycol DiheptanoateINACTIVE INGREDIENT5LKW3C543X1
PetrolatumINACTIVE INGREDIENT4T6H12BN9U1
Shea ButterINACTIVE INGREDIENTK49155WL9Y1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65AP1
Yellow WaxINACTIVE INGREDIENT2ZA36H0S2V1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49358-54549358-545-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 110 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PetrolatumPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
High Density PolyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7OINTMENT / TOPICAL94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
High Density PolyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7SUPPOSITORY / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii candidate
26 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii candidate
26 equally ranked IID candidates
Glyceryl IsostearateGLYCERYL ISOSTEARATEHYE7O27HAOCREAM / VAGINAL135 mgExact identifier — unii candidate
2 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APPOWDER, FOR SUSPENSION / ORAL1203 mg/5mlExact identifier — unii candidate
26 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KAEROSOL, FOAM / TOPICAL4 mgExact identifier — unii candidate
32 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE / ORAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET / BUCCAL6 mgExact identifier — unii candidate
26 equally ranked IID candidates
High Density PolyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7TABLET, EXTENDED RELEASE / ORAL0.64 mgExact identifier — unii candidate
18 equally ranked IID candidates
Yellow WaxYELLOW WAX2ZA36H0S2VTABLET, COATED / ORAL213.7 mgExact identifier — unii candidate
9 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / TOPICAL8 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
Aluminum HydroxideALUMINUM HYDROXIDE5QB0T2IUN0OINTMENT / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KLOTION / TOPICAL1000 mgExact identifier — unii candidate
32 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
Shea ButterSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii candidate
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSPRAY / TOPICAL3 mgExact identifier — unii candidate
32 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS0.02 mgExact identifier — unii candidate
32 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KGEL, METERED / TOPICAL4 mgExact identifier — unii candidate
32 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KGUM, CHEWING / BUCCAL5 mgExact identifier — unii candidate
32 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APEMULSION / ORALNAExact identifier — unii candidate
26 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APSOLUTION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
Yellow WaxYELLOW WAX2ZA36H0S2VCAPSULE / ORAL44 mgExact identifier — unii candidate
9 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KOINTMENT / TOPICAL57 mgExact identifier — unii candidate
32 equally ranked IID candidates
High Density PolyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7PASTE / DENTAL60 mgExact identifier — unii candidate
18 equally ranked IID candidates
Glyceryl IsostearateGLYCERYL ISOSTEARATEHYE7O27HAOCREAM / TOPICAL2 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KFILM, SOLUBLE / ORAL0.06 mgExact identifier — unii candidate
32 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KGEL / TOPICAL8 mgExact identifier — unii candidate
32 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSWAB / TOPICAL0.5 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
High Density PolyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7OINTMENT / OPHTHALMICNAExact identifier — unii candidate
18 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii candidate
26 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APEMULSION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
Yellow WaxYELLOW WAX2ZA36H0S2VOINTMENT / TOPICAL20 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APCREAM / VAGINAL1088 mgExact identifier — unii candidate
26 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET / SUBLINGUAL9 mgExact identifier — unii candidate
26 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APOINTMENT / TOPICAL15 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
High Density PolyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7GEL / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
High Density PolyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii candidate
18 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE, EXTENDED RELEASE / ORAL0.03 mgExact identifier — unii candidate
32 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / VAGINALNAExact identifier — unii candidate
32 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
Yellow WaxYELLOW WAX2ZA36H0S2VTABLET, DELAYED RELEASE / ORAL0.1 mgExact identifier — unii candidate
9 equally ranked IID candidates
High Density PolyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7TABLET, COATED / ORAL25 mgExact identifier — unii candidate
18 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
26 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / VAGINAL4 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / RECTAL1 mgExact identifier — unii candidate
32 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / TOPICAL6 mgExact identifier — unii candidate
32 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
26 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
High Density PolyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7TABLET / ORAL50 mgExact identifier — unii candidate
18 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
26 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM, AUGMENTED / TOPICAL0.2 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
High Density PolyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7PASTE / TOPICAL2.5 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
High Density PolyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7SUPPOSITORY / RECTALNAExact identifier — unii candidate
18 equally ranked IID candidates

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
3bb7a046-eb50-41e7-b652-46d5ebcd91dfc61390b8-e536-4a5c-b0b5-2f427ba9b62d2023-08-31WarningsExact identifier
spl set id: c61390b8-e536-4a5c-b0b5-2f427ba9b62d

Reported adverse events (FAERS/openFDA)#

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