SPF 60 Mineral Sunscreen

Manufacturer
Derma Care Research Labs, LLC
Effective date
2023-11-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:02:34

Label at a glance#

ProductSPF 60 Mineral Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 6%, Zinc Oxide 4.6%

OTC - PURPOSE SECTION

Sunscreen

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 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 or irritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Apply liberally 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 value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10:00 a.m. - 2:00 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT SECTION

Aluminum hydroxide, beeswax, BHT, butyloctyl salicylate, C12-15 alkyl benzoate, cetyl alcohol, dimethicone, euphoria cerifera (candelilla) wax, isostearic acid, neopentyl glycol diethylhexanoate, ozokerite, paraffin, polyethylene, stearic acid, triethoxycaprylysilane

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabelLabelLabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72839-547-01SPF 60 Mineral Sunscreen14 g in 1 CYLINDERSTICK141
72839-547-11SPF 60 Mineral Sunscreen14 g in 1 CYLINDERSTICK141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72839-547SPF 60 MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) STICK [DERMA CARE RESEARCH LABS, LLC]1Current NDC, 2 package rows20231122_0aae69f1-66bf-a199-e063-6394a90a3d75.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72839-54772839-547-01, 72839-547-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
SPF 60 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aae69f1-66bf-a199-e063-6394a90a3d752023-11-21WarningsExact identifier
ndc (package): 72839-547-11
ndc (package): 72839-547-01
ndc (product): 72839-547
ndc11 (package): 72839054701
ndc11 (package): 72839054711
spl id: 0aae69f1-66c0-a199-e063-6394a90a3d75
spl set id: 0aae69f1-66bf-a199-e063-6394a90a3d75

Reported adverse events (FAERS/openFDA)#

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