Mineral Sunscreen

Manufacturer
TUBBY TODD
Effective date
2022-03-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:06:08

Label at a glance#

ProductMineral Sunscreen SPF-50
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 generously 15 minutes before sun exposure and as needed. Reapply      after 80 minutes of swimming or sweating      immediately after towel drying      at least every 2 hours Sun Protection Measures: Spending time in the sun 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 measure...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 5%
Zinc Oxide 7%

PURPOSE

OTC - PURPOSE SECTION

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.
• Do not use on damaged or broken skin.
• When using this product keep out of eyes. Rinse with water to remove.
• Stop use and ask a doctor if rash occurs.

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 generously 15 minutes before sun exposure and as needed.
  • Reapply
  •      after 80 minutes of swimming or sweating
  •      immediately after towel drying
  •      at least every 2 hours
  • Sun Protection Measures: Spending time in the sun 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 including:
  •      limit time in the sun, especially from 10 a.m.-2 p.m.
  •      wear long-sleeved shirts, pants, hats, and sunglasses".
  • Children under 6 months of age: ask a doctor

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Water, Caprylic Capric Triglycerides, C12-C15 Alkyl Benzoate, Triethoxycaprylsilane, Glycerin, Propanediol, Dicaprylyl Ether, lsostearic Acid, Polyhydroxystearic Acid, Octyldodecyl Stearyl Citrate Crosspolymer, Phenoxyethanol, Benzoic Acid, Ethylhexylglycerin, Glycereth-2 Cocoate, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Chloride, Sodium Hyaluronate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_TubbySunscreen_tube_061819-201b LBL_TubbySunscreen_tube_061819-2

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73088-10473088-104-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

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
29924c5f-f2e1-27f3-e063-6294a90ad1893517ba13-37a2-4677-bfef-55d53e7059322024-12-18WarningsExact identifier
spl set id: 3517ba13-37a2-4677-bfef-55d53e705932

Reported adverse events (FAERS/openFDA)#

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