Otc - Active Ingredient
Zinc Oxide 19.24%
Paulas Choice On-the-go Shielding Powder Broad Spectrum Spf 30
FDA Label NDC 76144-237
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 On-the-go Shielding Powder Broad Spectrum Spf 30 (NDC 76144-237). 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, instructions for use, dosage & administration, indications & usage, warnings, otc - do not use, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Instructions For Use
- Apply liberally 15 minutes before sun exposure.
- Use a water-resistant sunscreen if swimming or sweating:
- Immediately after towel drying.
- At least every two hours.
Remove cap. On first use remove plastic plug from center of brush and discard. Sweep brush over face, neck, and décolletage to release powder. Magnetic brush head can be removed for cleaning.
Dosage & Administration
Remove cap. On first use remove plastic plug from center of brush and discard. Sweep brush over face, neck, and décolletage to release powder. Magnetic brush head can be removed for cleaning.
Indications & Usage
- Apply liberally 15 minutes before sun exposure.
- Use a water-resistant sunscreen if swimming or sweating:
- Immediately after towel drying.
- At least every two hours.
Warnings
For external use only.
When using this product keep out of eyes. Rinse with water to remove.
Otc - Do Not Use
Stop use and ask a doctor if rash occurs.
Otc - Ask Doctor/Pharmacist
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.
Inactive Ingredient
Synthetic Fluorphlogopite, Boron Nitride, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Silica, Oryza Sativa (Rice) Bran Starch, Butylene Glycol, Stearic Acid, Ceramide NP, Tocopherol, Olive Glycerides, Ascorbyl Palmitate, Salix Nigra (Willow) Bark Extract, Water (Aqua), Triethoxycaprylylsilane, Polymethylsilsesquioxane, Nylon-6/12, EDTA, Retinyl Palmitate, Potassium Sorbate, Chlorphenesin, Iron Oxides (CI 77491, CI 77492, CI 77499).
Other Safety Information
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this reis, regularly use a sunscree with a broad spectrum SPF or 15 or higher and other sun preotectin measures, including:
- Limit time in the sun, especially from 10AM-2PM.
- Wear long-sleeve shirts, pants, hats and sunglasses.
Other information
Protect the product in this container from excessive heat and direct sun. Store at 20-25C (68-77F).
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