Otc - Active Ingredient
Titanium Dioxide 3.85%
Zinc Oxide 3.12%
Paulas Choice Calm Redness Relief Spf 30 Mineral Moisturizer (normal To Dry)
FDA Label NDC 76144-913
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Paula's Choice, Llc. for the product Paulas Choice Calm Redness Relief Spf 30 Mineral Moisturizer (normal To Dry) (NDC 76144-913). 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, uses, warnings, otc - keep out of reach of children, otc - when using, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Uses
Helps prevent sunburn. Decreases the risk of skin cancer and early skin agining caused by the sun if used as directed with other sun protection measures (see Directions).
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 and irritation develops and lasts. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center immediately.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Otc - When Using
Keep out of eyes. Rinse with water to remove.
Otc - Ask Doctor
Stop use and ask a doctor if rash and irritation develops and lasts.
Otc - Stop Use
Stop use if rash and irritation develop and lasts.
Other Information
Store at 20-25°C (68-77°F). You may report serious adverse reactions to 705 5th Avenue South, Suite 200, Seattle, WA 98104.
Inactive Ingredient
Water (Aqua), C12-15 Alkyl Benzoate, Isononl Isononanoate, Prunus Armeniaca (Apricot) Kernel Oil, Glyceryl Stearate, PEG-100 Stearate, Cyclopentasiloxane, Butylene Glycol, Pentylene Glycol, Cetearyl Alcohol, Dimethicone, VP/Eicosene Copolymer, Glycine Soja (Soybean) Sterols, Avena Sativa (Oat) Kernel Extract, Glycerin, Sodium Hyaluronate, Allantoin, Tocopheryl Acetate, Hydrogenated Lecithin, Tetrahexyldecyl Ascorbate, Superoxide Dismutase, Ubiquinone, Ceramide NG, Methicone, Palmitoyl Hexapeptide-12, PEG-10 Dimethicone, Cucumis Sativus (Cucumber) Fruit Extract, Caprylic/Capric Triglyceride, Tibehenin, Peg-10 Phytosterol, Sorbitan Stearate, Polyhydroxystearic Acid, Alumina, Polysorbate 20, Aluminum Stearate, Xanthan Gum, Caprylyl Glycol, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Chlorphenesin.
Package Label.Principal Display Panel
Artwork (9137 Component Travel Paths Page 001)
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