Otc - Active Ingredient
Zinc Oxide 20%
Mineral Sunscreen Lotion
FDA Label NDC 84380-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Daily Suncare Llc, Dba Daily Shade for the product Mineral Sunscreen (NDC 84380-001). 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, dosage & administration, otc - purpose, indications & usage, instructions for use, warnings, otc - keep out of reach of children, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration
Topical Lotion
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.
Instructions For Use
Apply generously and evenly 15 minutes before sun exposure. Apply to all skin exposed to the sun at least every 2 hours. Reapply after 40 minutes of swimming or sweating. Children under 6 months of age: ask a doctor.
Sun Protection Measures: Spending time in the sun increases risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or highre and other sun protection measures including: limit time in the sun, especially from 10am-2pm, wear long-sleeved shirts, pants, hats, and sunglasses.
Warnings
For external use only. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Other Safety Information
Protect the product in this container from excessive heat and direct sun.
Otc - Ask Doctor
Stop use and ask a doctor if rash occurs. Children under 6 months of age: ask a doctor
Inactive Ingredient
Aqua/Water/Eau, Caprylic/Capric Triglyceride, Undecane, Isoamyl Laurate, Polyglyceryl-6 Polyhydroxystearate, Tridecane, Glycerin, Magnesium Sulfate, Octyldodecyl Stearoyl Stearate, Polyglyceryl-6 Polyricinoleate,Brassica Napus Extract, Stearalkonium Bentonite, Triethyl Citrate, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Polyhydroxystearic Acid, Bixa Orellana Leaf Extract, Deoxyribonuclease, Glucose Oxidase, Jacaranda Mimosifolia Flower Extract, Kalanchoe Pinnata Leaf Extract, Raspberry Ketone, Sodium Citrate, Xanthan Gum, Squalane, Jojoba Esters, Polyglyceryl-3 Diisostearate, Stearoyl Glutamic Acid, Mica, Triethoxycaprylylsilane, Tocopherol, Iron Oxides
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