Otc - Active Ingredient
Zinc Oxide 18%
Titanium Dioxide 6%
True Coast Spf 50 Mineral Sunscreen Cream
FDA Label NDC 84938-016
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Foshan Sugar Max Cosmetics Co.,ltd for the product True Coast Spf 50 Mineral Sunscreen (NDC 84938-016). 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 - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, 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 cancer and early skin aging caused by exposure to the sun.
Warnings
For external use only.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product Keep out of eyes.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Apply liberally 15 minutes before sun exposure.
Reapply
After 80 minutes of swimming or sweating
At least every 2 hours.
Sun Protection Measures.Spending time in the sun
increases your risk of skin cancer and early skin aging. To
decreasethe 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 10am to 2pm.
Wear long-sleeve shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor.
Inactive Ingredient
Water (Aqua)
Cyclopentasiloxane
Dimethicone
Isododecane
C12-15 Alkyl Benzoate
Caprylic/Capric Triglyceride
Trimethylsiloxysilicate
Acrylates/Octylacrylamide Copolymer
PEG-30 Dipolyhydroxystearate
Polyhydroxystearic Acid
Silica
Alumina
Tocopherol
Phenoxyethanol
Package Label.Principal Display Panel
Label1 (Label1)
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