Otc - Active Ingredient
Zinc Oxide - 7.8%Octlnoxote - 7.5% Octlsolote - 4.0%
Sun Total Protector Color 30 Dark Tint
FDA Label NDC 66078-505
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Md Formulations for the product Sun Total Protector Color 30 Dark Tint (NDC 66078-505). 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, otc - when using, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Zinc Oxide - 7.8% SunscreenOctlnoxote - 7.5% SunscreenOctlsolote - 4.0% Sunscreen
Otc - When Using
When using this product do not use In or near the eyes. If product gets Into eyes, rinse thoroughly with water.
Indications & Usage
Uses to help prevent sunburn and for the temporary protection of sunburn.
Warnings
Warnings : For external use only.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash appears and lasts.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Polson Control Center right away.
Dosage & Administration
Children under 2 years of age should use sunscreen products with a minimum SPF of 4. Adults and children 6 months and over; apply liberally 15 minutes before sun or water exposure; reapply after swimming or excessive sweating or anytime after towel drying. Children under 6 monthsask a doctor.
Other
Other information Store at 20-25C (68 - 77F) Sun Alert: The sun causes sun damage. Regular use of sunscreens over the years may reduce the chance of skin damage, some types of skin cancer, and other harmful effects due to the sun.
Inactive Ingredient
Inactive ingredients: Purified Water (Aqua), C12-15 Alkyl Benzoate, Glyceryl Stearate, Glycerin, Stearelh·2, Stearelh-100, Trlcontanyl PVP, PEG-100 stearate, Tocopheryl Acetate, Allontoln, Dlmethlcone, Xanthun Gum, Cetyl Hydroxyethylcellulose, Disodium EDTA, Dlazolldlnyl Urea, lodopropynl Butylcarbamate, Methyldlbromo Glutaronllrlle, Phenoxyethcnol, Methylparaben, Propylparaben, MIca (CI 77019), Blsmulh OxychlorIde (CI 77163), Iron Oxides (CI77489)
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