Otc - Active Ingredient
Titanium Dioxide 6%, Zinc Oxide 4.6%
Spf 60 Mineral Sunscreen Stick
FDA Label NDC 72839-547
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Derma Care Research Labs, Llc for the product Spf 60 Mineral Sunscreen (NDC 72839-547). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
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
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
If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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
- 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.
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:
Inactive Ingredient
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
Label (Abs Min60 30 Psys 356269 001)
Label (Abs Bmin6 30 Psys 356270 001)
Label (Abs Min60 31 Psys 356271 001)
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